What is Dulcolax

Dulcolax is a stimulant laxative used to relieve constipation and also to prepare the bowel for diagnostic or surgical procedures requiring the bowel to be empty. The active ingredient in Dulcolax is Bisacodyl, which is a diphenylmethane laxative that acts by directly stimulating the nerve endings in the mucosa of the colon, increasing the movement of the intestines. Dulcolax (Bisacodyl) can help you empty your bowels if you have constipation (difficulty pooing).

Dulcolax (Bisacodyl) is used in hospitals to help you empty your bowels before surgery or some examinations or treatments. Your hospital will explain how to use it.

Dulcolax (Bisacodyl) comes as a tablet and a suppository (a medicine that you push gently into your back passage).

The Dulcolax (Bisacodyl) tablets and suppositories are available on prescription and to buy from pharmacies.

Key facts

• Dulcolax (Bisacodyl) tablets take 6 to 12 hours to work.
• Dulcolax (Bisacodyl) suppositories take 10 to 45 minutes to work, so it’s best to stay close to a toilet.
• The most common side effects are feeling sick (nausea), diarrhea, stomach pain or cramps.
• Only give Dulcolax (Bisacodyl) to children if their doctor recommends it.
• Do not take Dulcolax (Bisacodyl) tablets or use Dulcolax (Bisacodyl) suppositories every day for more than 5 days.
• Bisacodyl is also called by the brand name Alophen Pills, Bisac-Evac, Carter’s Little Pills, Correctol, Dulcolax, Feen-A-Mint, Fleet Bisacodyl, Bisacodyl Uniserts, Fleet Bisacodyl Enema, Dulcolax Bowel Prep Kit and Dulcolax.

How does Dulcolax work

Dulcolax (Bisacodyl) is in a class of medications called stimulant laxatives. It works by increasing activity of the intestines to cause a bowel movement.

Dulcolax (Bisacodyl) is used on a short-term basis to treat constipation. It also is used to empty the bowels before surgery and certain medical procedures.

Dulcolax (Bisacodyl) has been used to facilitate flushing of colostomies and may reduce or eliminate the need for irrigations.

Dulcolax (Bisacodyl) is used:

• to treat constipation that occurs following prolonged bed rest or hospitalization.
• to treat chronic constipation associated with opiate therapy.
• to treat constipation occurring secondary to idiopathic slowing of transit time, to constipating drugs, or to irritable bowel or spastic colon syndrome.
• to treat constipation in patients with neurologic constipation.

How should Dulcolax be used?

Dulcolax (Bisacodyl) comes as a tablet to take by mouth. Swallow the tablets whole with a glass of water; do not split, chew, or crush them. Do not take Dulcolax (Bisacodyl) within 1 hour after drinking or eating dairy products. Dulcolax (Bisacodyl) is usually taken the evening before a bowel movement is desired. Do not take Dulcolax (Bisacodyl) more than once a day or for more than 1 week without talking to your doctor. Follow the directions on the package or on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take Dulcolax (Bisacodyl) exactly as directed. Frequent or continued use of Dulcolax (Bisacodyl) may make you dependent on laxatives and cause your bowels to lose their normal activity.

What special dietary instructions should I follow?

A regular diet and exercise program is important for regular bowel function. Eat a high-fiber diet and drink plenty of liquids (eight glasses) each day as recommended by your doctor.

How long does it take for Dulcolax to work?

Dulcolax (Bisacodyl) tablet taken by mouth normally causes a bowel movement within 6 to 12 hours. If you do not have a regular bowel movement after taking Dulcolax (Bisacodyl), do not take any more medication and talk to your doctor.

Dulcolax (Bisacodyl) suppositories take 10 to 45 minutes to work, so it’s best to stay close to a toilet.

How long should I take Dulcolax for?

Do not take Dulcolax (Bisacodyl) every day for more than 5 days. If you are still constipated after that, talk to your doctor.

Is it safe to take Dulcolax for a long time?

Ideally, you should only use Dulcolax (Bisacodyl) occasionally and for a few days at a time.

Using laxatives like Dulcolax (Bisacodyl) for longer can lead to a fluid and salt imbalance in your body and you may become dehydrated.

If you need to use laxatives every day for a longer time, talk to your doctor.

With long term use or overdosage of stimulant laxatives, electrolyte disturbances including hypokalemia, hypocalcemia, metabolic acidosis or alkalosis, abdominal pain, diarrhea, malabsorption, weight loss, and protein-losing enteropathy may occur ¹. Electrolyte disturbances may produce vomiting and muscle weakness; rarely osteomalacia, secondary aldosteronism, and tetany may occur. Pathologic changes in including structural damage to the myenteric plexus, severe and permanent interference with colonic motility, and hypertrophy of the muscularis mucosae may occur with chronic use ¹.

Can I take different laxatives together?

For most people, 1 laxative will be enough to make your constipation better.

Occasionally, you may need to take 2 different types of laxatives at the same time to get your bowels moving again. Only take 2 laxatives together if your doctor or pharmacist tell you to as this increases the risk of side effects.

Are other laxatives any better?

There are other types of laxative. They work in a different way from Dulcolax (Bisacodyl), but are equally good at treating constipation.

• Bulk-forming laxatives, for example Fybogel and methylcellulose. These increase the “bulk” or weight of poo, which in turn stimulates bowel movement. They take 2 or 3 days to work.
• Osmotic laxatives, for example lactulose. These draw water from the rest of the body into your bowel to soften your poo and make it easier to pass. They take at least 2 days to work.
• Stimulant laxatives, for example senna. These stimulate the muscles that line your gut, helping them to move poo along your gut to your back passage. Senna takes about 8 hours to work.

Can I use Dulcolax after surgery?

It’s quite common to have constipation after surgery. Using a laxative may help.

If you have constipation after an operation, it’s better to use lactulose because it is gentler than Dulcolax (Bisacodyl). You can get it on prescription or buy it from pharmacies.

Can lifestyle changes help constipation?

It’s often possible to improve constipation without having to use laxatives. Before trying Dulcolax (Bisacodyl) – or to stop constipation coming back – it may help to:

• eat more fiber – aim for about 30-35 g of fiber a day. High-fiber foods include fruit, vegetables and cereals. If you’re not used to a high-fiber diet, increase the amount of fiber you eat gradually.
• add bulking agents, such as wheat bran, to your diet. These will help make your poo softer and easier to pass (although bran and fiber can sometimes make bloating worse).
• drink plenty of water – to keep poo soft.
• exercise regularly – keeping your body active will help to keep your gut moving.
• go to the toilet when you need to, rather than holding it in.

Who can and can’t take Dulcolax

Dulcolax (Bisacodyl) can be used by adults.

Dulcolax (Bisacodyl) can also be used by children, if their doctor recommends it. Doctors normally only recommend it for children aged 4 years and older. Occasionally, they recommend it for children aged 2 years and older.

Dulcolax (Bisacodyl) enteric-coated tablets are not recommenced for children up to 6 years of age since patients in this age group may have difficulty swallowing the tablet without chewing it ². Gastric irritation may develop if the enteric coating is destroyed by chewing ².

Furthermore, laxatives should not be given to young children unless prescribed by a physician. Since children are not usually able to describe their symptoms precisely, proper diagnosis should precede the use of laxatives ². This will avoid the complication of an existing condition (e.g., appendicitis) or the appearance of more severe side effects ².

Dulcolax (Bisacodyl) isn’t suitable for some people. To make sure it’s safe for you, tell your doctor or pharmacist if you have:

• ever had an allergic reaction to Dulcolax (Bisacodyl) or any other medicines in the past
• signs of dehydration
• severe stomach pain and you are feeling sick or being sick (nausea or vomiting)
• a serious problem in your tummy (abdomen), such as appendicitis, a blockage in your bowel (intestinal obstruction), ulcerative colitis or Crohn’s disease, or a problem with the muscles in your bowel not being able to move food and liquid along

For Dulcolax (Bisacodyl) tablets, also tell your doctor or pharmacist if you:

• can’t digest some sugars – the tablets contain a small amount of lactose and sucrose

For Dulcolax (Bisacodyl) suppositories, also tell your doctor or pharmacist if you have:

• ever had an allergic reaction to suppositories
• tears or open sores (anal fissures) or cracked skin around your back passage (anus)

Before taking Dulcolax – Precautions

• tell your doctor and pharmacist if you are allergic to Dulcolax (Bisacodyl), any other medications, or any of the ingredients in these products. Check the label or ask your pharmacist for a list of the ingredients.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• if you are taking antacids, wait at least 1 hour before taking Dulcolax (Bisacodyl).
• tell your doctor if you have stomach pain, nausea, vomiting, or a sudden change in bowel movements lasting more than 2 weeks.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking Dulcolax (Bisacodyl), call your doctor.
• talk to your doctor about the risks and benefits of taking this medication if you are 65 years of age or older. Older adults should not usually take Dulcolax (Bisacodyl) because it is not as safe or effective as other medications that can be used to treat the same condition.
• Stimulant laxatives are habit forming and long term use of these drugs may result in laxative dependence and loss of normal bowel function ¹.

Cautions with other medicines

Some medicines – and some foods – interfere with the way Dulcolax (Bisacodyl) works.

For safety, tell your doctor or pharmacist if you are taking any other medicines, including herbal remedies, vitamins or supplements.

They include:

• water tablets (diuretics), steroids (like prednisolone) or digoxin (a heart medicine) – these can upset the balance of salts and minerals in your body if you have too much Dulcolax (Bisacodyl) by accident. If you are taking digoxin, this imbalance makes it more likely you will have the serious side effects of digoxin. It’s important not to take too much Dulcolax (Bisacodyl) if you are taking any of these medicines.
• indigestion remedies (antacids) and dairy products like milk, cheese and yogurt – these interact with Dulcolax (Bisacodyl) tablets and stop them working properly. They can also make the Dulcolax (Bisacodyl) irritate your stomach and give you indigestion. Do not take Dulcolax (Bisacodyl) at the same time – leave a gap of 1 hour before or after taking Dulcolax (Bisacodyl) if you are having indigestion remedies or dairy products. The small amount of milk in coffee and tea is unlikely to affect it, but it’s best to take Dulcolax (Bisacodyl) tablets with a glass of water.

Mixing Dulcolax (Bisacodyl) with herbal remedies or supplements

There is not enough research to know if complementary medicines and herbal remedies are safe to take with Dulcolax (Bisacodyl).

Dulcolax in Pregnancy and Breastfeeding

Tell your pharmacist or doctor if you are trying to get pregnant, already pregnant, or breastfeeding.

FDA Pregnancy Risk Category B: NO EVIDENCE OF RISK IN HUMANS. Adequate, well controlled studies in pregnant women have not shown increased risk of fetal abnormalities despite adverse findings in animals, or, in the absence of adequate human studies, animal studies show no fetal risk. The chance of fetal harm is remote but remains a possibility ³.

Dulcolax (Bisacodyl) tablets or suppositories are not generally recommended if you are pregnant, especially in the first 3 months and while you are breastfeeding. Talk to your doctor about the benefits and risks of taking Dulcolax (Bisacodyl).

If you are pregnant or breastfeeding, it’s always better to try to treat constipation without taking a medicine. Your doctor or midwife will first advise you to eat more fibre and drink plenty of fluids. It may also help to do gentle exercise.

If diet and lifestyle changes do not work, your doctor or midwife may recommend another laxative, such as lactulose or Fybogel. These are safer laxatives to take during pregnancy and while breastfeeding.

I just found out I am pregnant. Should I stop taking Dulcolax?

Always talk with your healthcare provider before making any changes in your medications. It is important to consider the benefits of treating constipation symptoms during pregnancy.

Constipation may cause pain and other health problems in pregnancy such as cramps, hemorrhoids, and breakdown of the anal tissue. Treating constipation will help reduce the risk of these problems. Dietary changes such as increasing fluids, eating high fiber foods such as whole grains and fresh fruits and vegetables can help prevent constipation. Regular exercise can also help. Although occasional constipation is common in pregnancy, talk with your healthcare provider if constipation becomes an ongoing problem. Your healthcare provider may also want to confirm the diagnosis of constipation and see how dietary and exercise changes can help before discussing medical treatment.

Can the use of laxatives during pregnancy cause birth defects?

Few studies have been done to look at the possible risks from using laxatives during pregnancy. However, the available studies show that when used in recommended doses, laxatives are not expected to increase the risk of birth defects or pregnancy problems.

Are there other concerns when using laxatives?

Yes. Laxatives may reduce the amount of nutrition and medicines that get into the blood since laxatives can make food go through the intestines faster than usual. Nutritional problems are only seen when these agents are used more than recommended.

When more than the recommended amounts of laxatives are used, some can also lower the levels of salts, such as magnesium, in a person’s blood. There is one reported case of low magnesium levels in a newborn that was linked to the mother using too much docusate sodium. The baby’s main symptom was jitteriness, which went away by the second day of life.

Castor oil has been used at the end of pregnancy to bring on labor. It can cause severe diarrhea and cramping of the bowel and uterus. However, if the lower part of the uterus (cervix) is not ready, these contractions will not bring on labor. If you are at the end of your pregnancy, your health care provider can discuss other ways to begin labor.

Dulcolax and Breastfeeding

Dulcolax (Bisacodyl) is not absorbed from the gastrointestinal tract, and its active metabolite, which is absorbed, is not detectable in breastmilk ⁴. Dulcolax (Bisacodyl) can be taken during breastfeeding and no special precautions are required ⁴. Sixteen postpartum women who were not breastfeeding, but were producing at least 200 mL of milk daily by breast pump were given either oral enteric-coated bisacodyl tablets (Dulcolax) 10 mg daily or oral liquid sodium picosulfate (Laxoberal) 10 mg daily for 7 days ⁵. Both drugs are prodrugs metabolized to the active drug, bis-(p-hydroxyphenyl)-2-pyridyl-2-methane. All breastmilk was collected daily from the day before drug administration to 2 days after the last dose. Free and conjugated bis-(p-hydroxyphenyl)-2-pyridyl-2-methane were undetectable (<1 mcg/L) in all milk samples ⁵.

How and when to take Dulcolax

Before using rectal Dulcolax

• tell your doctor and pharmacist if you are allergic to Dulcolax (Bisacodyl), any other medications, or any of the ingredients in these products. Check the label or ask your pharmacist for a list of the ingredients.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have stomach pain, nausea, vomiting, a sudden change in bowel movements lasting more than 2 weeks, anal fissures, or hemorrhoids.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using rectal Dulcolax (Bisacodyl), call your doctor.
• talk to your doctor about the risks and benefits of using this medication if you are 65 years of age or older. Older adults should not usually use rectal Dulcolax (Bisacodyl) because it is not as safe or effective as other medications that can be used to treat the same condition.

How to take Dulcolax

Dulcolax (Bisacodyl) Tablets

• Take the medicine once a day just before bedtime.
• You can take it with or without food. Swallow the tablet whole with water.
• Do not have milk, indigestion remedies (antacids) or medicines to reduce stomach acid (for example, proton pump inhibitors) at the same time as Dulcolax (Bisacodyl). This is because they will stop the medicine working properly. Leave a gap of 1 hour between taking any of these and taking your Dulcolax (Bisacodyl) tablets.

Dulcolax (Bisacodyl) Suppositories

• Take the wrapping off and push a suppository gently into your back passage (anus).
• Suppositories work quickly (usually between 10 and 45 minutes), so use it when you know you will be near a toilet.
• Read the instructions in the leaflet inside the package. They will explain how to use the suppository.

Rectal Dulcolax (Bisacodyl) comes as a suppository and enema to use rectally. It is usually used at the time that a bowel movement is desired. The suppositories usually cause a bowel movement within 15 to 60 minutes and the enema within 5 to 20 minutes. Do not use Dulcolax (Bisacodyl) more than once a day or for more than 1 week without talking to your doctor. Follow the directions on the package or on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use rectal Dulcolax (Bisacodyl) exactly as directed. Frequent or continued use of Dulcolax (Bisacodyl) may make you dependent on laxatives and cause your bowels to lose their normal activity. If you do not have a regular bowel movement after using Dulcolax (Bisacodyl), do not use this medication again and talk to your doctor.

If using a Dulcolax (Bisacodyl) suppository, follow these steps:

1. If the suppository is soft, hold it under cool water or place it in the refrigerator for a few minutes to harden it before removing the wrapper.
2. Remove the wrapper.
3. If you were told to use half of the suppository, cut it lengthwise with a clean, sharp knife or blade.
4. Lie down on your left side and raise your right knee to your chest.
5. Using your finger, insert the suppository, pointed end first, into your rectum until it passes the muscular sphincter of the rectum, about 1 inch (2.5 centimeters) in adults. If not inserted past this sphincter, the suppository may pop out.
6. Hold it in place for as long as possible.
7. Wash your hands thoroughly.

If using a Dulcolax (Bisacodyl) enema, follow these steps:

1. Shake the enema bottle well.
2. Remove the protective shield from the tip.
3. Lie down on your left side and raise your right knee to your chest or kneel and lean forward so that your head and chest are resting comfortably.
4. Gently insert the enema bottle into the rectum with the tip pointing toward the navel.
5. Squeeze the bottle gently until the bottle is nearly empty.
6. Remove the enema bottle from the rectum. Hold the enema contents in place as long as possible, for up to 10 minutes.
7. Wash your hands thoroughly.

How much Dulcolax to take

Dulcolax (Bisacodyl) Tablets

The usual dose in:

• adults and children aged 12 years and over is 5—15 mg/day (1 to 3 tablets) once a day before bedtime
• children aged 6 to 11 years old is 5 mg (1 tablet) a day before bedtime, if their doctor recommends it

If you are an adult or child aged 10 and over and you have not taken Dulcolax (Bisacodyl) before, start with 1 tablet. If that doesn’t work well enough for you, you can take 2 tablets.

Dulcolax (Bisacodyl) Suppositories

The usual dose for:

• adults and children aged 12 years and over is 1 suppository (10mg) a day
• children 6 to 12 years old is 1 suppository (5mg) a day, if their doctor recommends it

What if I forget to take it?

If you forget a dose of Dulcolax (Bisacodyl), don’t worry. Just take the next dose at the usual time.

Never take 2 doses at the same time. Never take an extra dose to make up for a forgotten one.

What if I take too much?

Taking an extra dose of Dulcolax (Bisacodyl) by accident is unlikely to harm you. You may get diarrhea and stomach pain, but this should get better within a day or two.

If you’re worried, talk to your doctor or pharmacist for advice.

Is there any food and drink I need to avoid?

Do not take Dulcolax (Bisacodyl) at the same time as dairy products like milk, cheese or yogurt. Leave a gap of 1 hour between taking any of these and taking your Dulcolax (Bisacodyl) tablets. The small amount of milk in coffee and tea should not affect the Dulcolax (Bisacodyl) tablet.

It’s a good idea to stop eating pastries, cakes, puddings and cheese for a while as these can make constipation worse.

Can I drink alcohol with Dulcolax?

Yes, you can drink alcohol with Dulcolax (Bisacodyl).

Dulcolax dosage

Dulcolax Laxative Tablets

Active ingredient (in each suppository): Bisacodyl USP 5 mg
Purpose: Stimulant laxative

Dulcolax Laxative Tablets Warnings

• Dulcolax Laxative Tablets can be can be taken with water and must be swallowed whole.
• The tablets must NOT be chewed or crushed. Dulcolax Laxative Tablets are coated to prevent the active ingredient from being released until it reaches the part of the intestines where it is needed to work.
• Do not use if you cannot swallow without chewing

Ask a doctor before use if you have:

• stomach pain, nausea or vomiting
• a sudden change in bowel habits that lasts more than 2 weeks

When using this product it may cause stomach discomfort, faintness, rectal burning and mild cramps.

Stop use and ask a doctor if:

• you have rectal bleeding or no bowel movement after using this product. These could be signs of a serious condition.
• you need to use a laxative for more than 1 week

If pregnant or breast-feeding, ask a health professional before use.

• Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
• Do not use this product if the individual seal is broken

Dulcolax Laxative Tablets Use

• for temporary relief of occasional constipation and irregularity
• this product generally produces bowel movement in 6 to 12 hours
• Dulcolax Laxative Tablets can generally be taken at any time except within one hour of consuming dairy products or antacids. Dulcolax Laxative tablets have a special ‘enteric coating’, which protects the tablet from the stomach’s acidic environment and ensures it is released in the small intestine where it is needed most.

When using Dulcolax Laxative Tablets:

• do not chew or crush tablet(s)
• do not use within 1 hour after taking an antacid or milk
• it may cause stomach discomfort, faintness and cramps

Dulcolax Laxative Tablets Dosage

• Take Dulcolax Laxative Tablets with a glass of water
• Adults and children 12 years of age and over: 1 to 3 tablets in a single daily dose
  • If this is the first time you are taking this product, it’s recommend taking 1 to 2 tablets in a single daily dose. It is suggested to take the tablets within 30 to 60 minutes before your normal bedtime to produce a bowel movement the next morning. With experience, you may increase your daily dosage to 2 or 3 tablets, if needed.
• Children 6 to under 12 years of age: 1 tablet in a single daily dose
• Children under 6 years of age: Ask a doctor

What time of day should I take Dulcolax Laxative Tablets?

It is recommended that you take Dulcolax Laxative Tablets when you can allow 6 to 12 hours for the product to work. You may find that it is most convenient to take the product about 30 to 60 minutes before your normal bedtime in order to produce a bowel movement in the morning.

Can I take Dulcolax Laxative Tablets with milk or dairy products?

No. This product should not be taken with milk or dairy products. Do not take Dulcolax laxative tablets within one hour of taking indigestion remedies (antacids) or dairy products such as milk or yogurt as these could cause the tablet’s comfort (enteric) coating to dissolve before it reaches the colon which may result in vomiting or cramping.

Is it safe to use Dulcolax Laxative Tablets on a daily basis?

You may take up to 3 Dulcolax Laxative Tablets a day for up to 7 days. If you need to use a laxative for more than 7 days, consult a health professional.

Dulcolax Laxative Suppositories

Active ingredient (in each suppository): Bisacodyl USP 10 mg
Purpose: Stimulant laxative

Dulcolax Laxative Suppositories Warnings

• For rectal use only. They are NOT intended for oral or vaginal use.
  

Ask a doctor before use if you have:

• stomach pain, nausea or vomiting
• a sudden change in bowel habits that lasts more than 2 weeks

When using this product it may cause stomach discomfort, faintness, rectal burning and mild cramps.

Stop use and ask a doctor if:

• you have rectal bleeding or no bowel movement after using this product. These could be signs of a serious condition.
• you need to use a laxative for more than 1 week

If pregnant or breast-feeding, ask a health professional before use.

• Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
• Do not use this product if the individual seal is broken

Dulcolax Laxative Suppositories Use

• for temporary relief of occasional constipation and irregularity
• this product generally produces bowel movement in 15 minutes to 1 hour

Dulcolax Laxative Suppositories Dosage

• Adults and children 12 years of age and over: 1 suppository in a single daily dose. Peel open plastic. Insert suppository well into rectum, pointed end first. Retain about 15 to 20 minutes.
• Children 6 to under 12 years of age: 1/2 suppository in a single daily dose
• Children under 6 years of age: Ask a doctor

What time of day should I take Dulcolax Laxative Suppositories?

You may take a Dulcolax Laxative Suppository anytime. It generally produces a bowel movement in 15 to 60 minutes.

How often can I take Dulcolax Laxative Suppositories?

Is it safe for daily use?

You may take 1 Dulcolax Laxative Suppository a day for up to 7 days. If you need to use a laxative for more than 7 days, consult a doctor.

How do I use Dulcolax Laxative Suppositories?

What does retain mean?

Remove the suppository from the plastic wrapping and insert the suppository, pointed end first, into the rectum. For best results, you should lie down for 15 to 20 minutes and try to retain the suppository for as long as you can. To retain the suppository means to keep the suppository in the rectum.

Do I need to remove the suppository after it has been inserted?

The Dulcolax Laxative Suppository does not need to be removed after it has been inserted; it works in the rectum within 15-60 minutes.

Dulcolax side effects

Like all medicines, Dulcolax (Bisacodyl) may cause side effects in some people, but many people have no side effects or only minor ones.

Common side effects

Common side effects, which happen in more than 1 in 100 people, are:

• feeling sick (nausea)
• diarrhea
• stomach pain or cramps
• stomach cramps
• faintness
• burning in the rectum (for rectal Dulcolax)

These side effects are mild and usually go away after a couple of days. Talk to your doctor or pharmacist if the side effects bother you or don’t go away.

Serious side effects

Call your doctor straight away if these rare side effects happen to you:

• feeling dizzy
• blood in your poo
• rectal bleeding
• being sick (vomiting)

Serious allergic reaction

In rare cases, it’s possible to have a serious allergic reaction to Dulcolax (Bisacodyl).

• A serious allergic reaction is an emergency. Contact a doctor straight away if you think you or someone around you is having a serious allergic reaction.

The warning signs of a serious allergic reaction are:

• getting a skin rash that may include itchy, red, swollen, blistered or peeling skin
• wheezing
• tightness in the chest or throat
• having trouble breathing or talking
• swelling of the mouth, face, lips, tongue or throat

These are not all the side effects of Dulcolax (Bisacodyl). For a full list, see the leaflet inside your medicines packet.

How to cope with side effects

What to do about:

• feeling sick – try taking Dulcolax (Bisacodyl) with some food.
• diarrhea – stop taking Dulcolax (Bisacodyl) and drink plenty of water or other fluids. Speak to a pharmacist if you have signs of dehydration, such as
• peeing less than usual or having dark, strong-smelling pee. Don’t take any other medicines to treat diarrhea without speaking to a pharmacist or doctor.
• stomach pain or cramps – reduce your dose of Dulcolax (Bisacodyl) or stop taking it until these side effects go away.

Human Toxicity Reports

Mild to moderate toxicity

• Nausea, vomiting, abdominal pain, and diarrhea have been reported.

Severe toxicity

• Fluid and electrolyte depletion, hypotension from extensive fluid losses, blisters, and skin sloughing of the buttocks and perineum with diarrhea.

Chronic toxicity

• Electrolyte abnormalities (e.g., hypochloremia, hypokalemia, hypocalcemia, hypomagnesemia), reflex bowel hypofunction, permanent colonic dysfunction (cathartic colon, causing chronic constipation, bloating, and abdominal pain), frank/occult gastrointestinal bleeding and associated anemia, steatorrhea, protein-loss gastroenteropathy, pancreatic dysfunction. Toxic hepatitis and jaundice have been reported following the chronic use of very large doses of senna.

In therapeutic oral doses, all stimulant laxatives may produce some degree of abdominal discomfort, nausea, mild cramps, griping, and/or faintness. Rectal administration of bisacodyl suspensions may cause irritation and a sensation of burning of the rectal mucosa and mild proctitis ¹.

Weakness, incoordination, and orthostatic hypotension may be exacerbated in elderly patients as a result of significant electrolyte loss when stimulant laxatives are used repeatedly to evacuate the colon ².

Suppository may produce mild feeling of a sharp stinging pain or tenesmus, and with continued rectal administration may cause proctitis ⁶. Sloughing of surface of epithelium of rectum has been observed. Inflammatory changes that occur after short-term use of bisacodyl suppositories may resemble those seen in mild idiopathic ulcerative proctitis.

Bisacodyl should not be given to patients with intestinal obstruction or acute abdominal conditions such as appendicitis; care should be taken in patients with inflammatory bowel disease. It should not be used in patients with severe dehydration. The suppositories should preferably be avoided in patients with anal fissures, proctitis, or ulcerated hemorrhoids ⁷.

A case report on a female patient with frequent, repetitive formation of kidney stones and rapid double J stent encrustation, which were related to the chronic abuse of bisacodyl. Although these stones can be fragmented successfully by extracorporeal shockwave lithotripsy, it seems that the better treatment for this type of stone formation is to avoid the abuse of laxatives ⁸.

A case report a case of ammonium acid urate stone due to laxative abuse ⁹. A 27-year-old female complained of left flank pain. Computed tomography revealed bilateral ureter stones (right 16.5 x 9.0 mm; left 4 mm), while left ureter stone was radiolucent on the plain X ray film. Bilateral hydronephrosis was seen, but no therapy was performed for the right stone, because 99mTc-MAG3 scintigraphy revealed that right kidney had no function. The left stone was successfully removed by transurethral approach. The stone was revealed to be an ammonium acid urate by infrared spectrophotometry. She had been taking many laxatives (bisacodyl, sennoside, aloe extract) for 12 years to control her body weight ⁹. Ammonium acid urate stones are rarely seen in developed countries. We have reviewed 9 cases in Japan, describing ammonium acid urate stones due to laxative abuse. Among these patients, 24-hour urine volume and excretion in urinary sodium were decreased, and serum aldosterone was increased. The involvement of laxative abuse should be considered when ammonium acid urate is formed in a woman with a low body mass index ⁹.

References

1. McEvoy, G.K. (ed.). American Hospital Formulary Service- Drug Information 2005. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 2005 (Plus Supplements)., p. 2784
2. Thomson.Micromedex. Drug Information for the Health Care Professional. 24th ed. Volume 1. Plus Updates. Content Reviewed by the United States Pharmacopeial Convention, Inc. Greenwood Village, CO. 2004., p. 1732
3. Cowl, C.T. Physician’s Handbook 10th edition. Lippincott Williams & Wilkins, Philadelphia, PA. 2003, p. 209
4. Bisacodyl https://toxnet.nlm.nih.gov/cgi-bin/sis/search2/f?./temp/~38hWnu:5
5. Friedrich C, Richter E, Trommeshauser D et al. Lack of excretion of the active moiety of bisacodyl and sodium picosulfate into human breast milk: an open-label, parallel group, multiple dose study in healthy lactating women. Drug Metab Pharmacokinet. 2011;26:458-64 https://www.jstage.jst.go.jp/article/dmpk/26/5/26_DMPK-11-RG-007/_pdf/-char/en
6. American Medical Association. AMA Drug Evaluations Annual 1991. Chicago, IL: American Medical Association, 1991., p. 813
7. Reynolds, J.E.F., Prasad, A.B. (eds.) Martindale-The Extra Pharmacopoeia. 28th ed. London: The Pharmaceutical Press, 1982., p. 1363
8. Wu WJ et al; J Formos Med Assoc 92 (11): 1004-6; 1993 https://www.ncbi.nlm.nih.gov/pubmed/7910057
9. Kato Y et al; Hinyokika Kiyo 50 (11): 799-803; 2004 https://repository.kulib.kyoto-u.ac.jp/dspace/bitstream/2433/113488/1/50_799.pdf

What is Midol

Midol is a medicine that contains these active ingredients: Acetaminophen 500 mg + Caffeine 60 mg + Pyrilamine maleate 15 mg

Midol is used for the temporary relief of these symptoms associated with menstrual periods:

• cramps
• bloating
• water-weight gain
• headache
• backache
• muscle aches
• fatigue

Midol active ingredients

Acetaminophen

Acetaminophen (paracetamol) is a common painkiller used to treat aches and pain. It can also be used to reduce fever (100.4 °F [38 °C] and above).

Acetaminophen (paracetamol) is used to relieve mild to moderate pain from headaches, muscle aches, menstrual periods, colds and sore throats, toothaches, backaches, and reactions to vaccinations (shots), and to reduce fever. Acetaminophen may also be used to relieve the pain of osteoarthritis (arthritis caused by the breakdown of the lining of the joints). Acetaminophen is in a class of medications called analgesics (pain relievers) and antipyretics (fever reducers). It works by changing the way the body senses pain and by cooling the body.

Acetaminophen (paracetamol) is also available combined with other painkillers and anti-sickness medicines. It’s an ingredient in a wide range of cold and flu remedies.

Key facts on Acetaminophen

• Acetaminophen (paracetamol) takes up to an hour to work.
• The usual dose of Acetaminophen (paracetamol) is one or two 500mg tablets at a time.
• Don’t take Acetaminophen (paracetamol) with other medicines containing Acetaminophen (paracetamol).

Who can and can’t take Acetaminophen

Most people can take Acetaminophen (paracetamol) safely, including pregnant and breastfeeding women.

However, some people need to take extra care with Acetaminophen (paracetamol).

Check with your doctor or pharmacist if you:

• have had an allergic reaction to Acetaminophen (paracetamol) or any other medicines in the past
• have liver or kidney problems
• regularly drink more than the maximum recommended amount of alcohol (14 units a week)
• take medicine for epilepsy
• take medicine for tuberculosis (TB)
• take the blood-thinner warfarin and you may need to take Acetaminophen (paracetamol) on a regular basis

Before taking acetaminophen

• tell your doctor and pharmacist if you are allergic to acetaminophen, any other medications, or any of the ingredients in the product. Ask your pharmacist or check the label on the package for a list of ingredients.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, or herbal products you are taking or plan to take. Be sure to mention anticoagulants (‘blood thinners’) such as warfarin (Coumadin); isoniazid (INH); certain medications for seizures including carbamazepine (Tegretol), phenobarbital, and phenytoin (Dilantin); medications for pain, fever, coughs, and colds; and phenothiazines (medications for mental illness and nausea). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have ever developed a rash after taking acetaminophen.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking acetaminophen, call your doctor.
• if you drink three or more alcoholic beverages every day, do not take acetaminophen. Ask your doctor or pharmacist about the safe use of alcoholic beverages while taking acetaminophen.
• you should know that combination acetaminophen products for cough and colds that contain nasal decongestants, antihistamines, cough suppressants, and expectorants should not be used in children younger than 2 years of age. Use of these medications in young children can cause serious and life-threatening effects or death. In children 2 through 11 years of age, combination cough and cold products should be used carefully and only according to the directions on the label.
• if you have phenylketonuria (PKU, an inherited condition in which a special diet must be followed to prevent mental retardation), you should know that some brands of acetaminophen chewable tablets may be sweetened with aspartame, a source of phenylalanine.

Side effects of Acetaminophen

Acetaminophen (paracetamol) very rarely causes side effects if you take it at the right dosage.

If you’re worried about a side effect or notice anything unusual, talk to your pharmacist or doctor.

Serious allergic reaction

In rare cases, it’s possible to have a serious allergic reaction to Acetaminophen (paracetamol).

If you experience any of the following symptoms, stop taking acetaminophen and call your doctor immediately or get emergency medical attention:

• red, peeling or blistering skin
• rash
• hives
• itching
• swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
• hoarseness
• difficulty breathing or swallowing

Acetaminophen may cause other side effects. Call your doctor if you have any unusual problems while you are taking this medication.

Cautions with other medicines

It’s safe to take Acetaminophen (paracetamol) with most prescription medicines, including antibiotics.

Acetaminophen (paracetamol) isn’t suitable for some people. Talk to your doctor if you take:

• the blood-thinner warfarin (Acetaminophen (paracetamol) can increase the risk of bleeding if you take it regularly)
• medicine to treat epilepsy
• medicine to treat tuberculosis (TB)

Mixing Acetaminophen (paracetamol) with herbal remedies and supplements

Check with your doctor or pharmacist if you’re taking the herbal medicine St John’s wort for depression as you may need to reduce your Acetaminophen (paracetamol) dose.

Otherwise, Acetaminophen (paracetamol) isn’t generally affected by also taking herbal remedies or supplements.

Acetaminophen Overdose

An overdose of acetaminophen can damage your liver or cause death. If someone takes more than the recommended dose of acetaminophen, get medical help immediately, even if the person does not have any symptoms.

The first signs of an acetaminophen overdose include loss of appetite, nausea, vomiting, stomach pain, sweating, and confusion or weakness. Later symptoms may include pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes.

Symptoms of acetaminophen overdose may include the following:

• nausea
• vomiting
• loss of appetite
• sweating
• extreme tiredness
• unusual bleeding or bruising
• pain in the upper right part of the stomach
• yellowing of the skin or eyes (jaundice)
• flu-like symptoms

Caffeine

Caffeine is a stimulant drug, which means it speeds up the messages traveling between the brain and your body.

It’s found in the seeds, nuts and leaves of a number of different plants, including:

• Coffea Arabica (used for coffee)
• Camelia sinensis (used for tea)
• Cola acuminate (used as a nut, tea or in soft drinks including cola)
• Theobroma cacao (used in cocoa and chocolate)
• Paulinia cupana (used as guarana in snack bars and energy drinks)

Caffeine is used in a number of different products. The amount of caffeine in these products can vary dramatically, so it’s always best to check the label. The average amounts are listed below.

• 2 tablets of Midol = 120mg caffeine

The table below shows the amount of caffeine in common food and drinks. The caffeine amounts are averages, so they may change depending on the brand or how the food or drink is made. Check the package label on food and drinks to know how much caffeine they contain.

The amount of caffeine in foods and drinks varies a lot. For coffee and tea, the amount of caffeine depends on:

• The brand
• How it’s prepared
• The type of beans or leaves used
• The way it’s served (for example, as espresso or latte)
• The size of the cup. Not all coffee cups are the same size, even though you think of them as a cup. Check to see how many ounces your cup has, especially if you’re buying a cup of coffee or tea. If you’re making coffee or tea at home, measure to check the size of the cup.

Table 1. The amount of Caffeine used in a number of different products (approximates only)

Product	Average caffeine content (mg/100 ml)
Red Bull®	32.0
Mountain Dew®	15.0
Coca Cola®	9.7*
Diet Coke®	9.7*
Coke Zero®	9.6*
Brewed black tea	22.5
Brewed green tea	12.1
Coffee, cappuccino	101.9
Coffee, flat white	86.9
Coffee, long black	74.7
Coffee, from ground coffee beans, espresso style	194.0
Chocolate, milk with added milk solids	20.0
Chocolate, dark, high cocoa solids	59.0

[Source ¹]

Some energy drinks contain large amounts of caffeine. For example, a 24-ounce energy drink may have up to 500 milligrams of caffeine. Energy drinks may have a lot of sugar, too, and they may contain ingredients that may be harmful to your baby during pregnancy. Because we don’t know a lot about all the ingredients in energy drinks, it’s best not to have them when you’re pregnant.

The amount of caffeine you get from food and drinks throughout the day adds up. So if you have a cup of coffee in the morning, you may want to limit or give up having other food and drinks during the day that have caffeine.

Effects of caffeine

Caffeine’s main effect is making people feel more awake for a short time. Caffeine aids the release of acid in the stomach, which can result in an upset stomach. Caffeine also helps get rid of fluids from the body (a diuretic).

There is no safe level of drug use. Use of any drug always carries some risk. It’s important to be careful when taking any type of drug.

Caffeine affects everyone differently, based on:

• Size, weight and health
• Whether the person is used to taking it
• Whether other drugs are taken around the same time
• The amount taken

The following effects may be experienced between 5 to 30 minutes after consuming caffeine, and may continue for up to 12 hours:

• Feeling more alert and active
• Restlessness, excitability and dizziness
• Anxiety and irritability
• Dehydration and needing to urinate more often
• Higher body temperature
• Faster breathing and heart rate
• Headache and lack of concentration
• Stomach pains ²

Children and young people who consume energy drinks containing caffeine may also suffer from sleep problems, bed-wetting and anxiety ³.

I am trying to become pregnant. Is it true that drinking caffeinated beverages will lower my chance to become pregnant?

Results from studies have been mixed. Some studies have suggested that high levels of caffeine (more than 300mg/day) might make it harder to conceive, but these findings are not proven. Low (less than 200mg/day) to moderate (about 200-300mg/day) caffeine consumption probably does not make it harder for a woman to get pregnant.

How does caffeine affect you and your baby during pregnancy?

Caffeine slightly increases your blood pressure and heart rate and the amount of urine your body makes. Caffeine may cause you to feel jittery, have indigestion or have trouble sleeping. During pregnancy, you may be especially sensitive to caffeine because it may take you longer to clear it from your body than if you weren’t pregnant.

When you have caffeine during pregnancy, it passes through the placenta to your baby. The placenta grows in your uterus (womb) and supplies the baby with food and oxygen through the umbilical cord.

You may have heard that too much caffeine can cause miscarriage (when a baby dies in the womb before 20 weeks of pregnancy). Some studies say this is true, and others don’t. Until scientists know more about how caffeine can affect pregnancy, it’s best to limit the amount you get to 200 milligrams each day. This is about the amount in 2 x 8-ounce cups of coffee or one 12-ounce cup of coffee. Be sure to check the size of your cup to know how much caffeine you’re getting.

Can caffeine cause or make it more likely to have a miscarriage?

There are many studies that have looked at this question. To date, researchers have not reported an association between low levels of caffeine and an increased risk for miscarriage. Most studies on moderate use of caffeine have not found an increased risk of miscarriage. Some studies suggest that taking very high levels (over 800 mg per day) or taking it in high doses with cigarettes or alcohol (both of which are known to increase the risk of miscarriage) may increase the risk for miscarriage.

Will drinking caffeinated beverages during my pregnancy cause birth defects in my baby?

No. Large amounts of caffeine have not been shown to cause an increased chance for birth defects.

Large amounts of caffeine could affect babies in the same way as it does adults. Some reports suggest that children born to mothers who consumed more than 500mg/day were more likely to have faster heart rates, shaking, increased breathing rate, and spend more time awake in the days following birth.

Does drinking caffeinated beverages in pregnancy cause long-term problems in behavior or learning for the baby?

Most studies find no effect on learning or behavior in young school aged children whose mothers consumed caffeine during pregnancy.

Can I drink caffeinated beverages while I breastfeed?

Caffeine passes into breast milk and it suggested that you limit how much you have. If you’re breastfeeding, limit caffeine to no more than two cups of coffee a day. The infant should also be watched for irritability and trouble with sleeping. It’s important to keep drinking water while breastfeeding. Be sure to talk to your health care provider about all your options for breastfeeding.

Is it a problem if the baby’s father consumes a lot of caffeine?

Studies on caffeine and male fertility or sperm quality have not reported consistent findings. In general, exposures that fathers have are unlikely to increase risks to a pregnancy.

Coming down

Some people consume drinks with caffeine so that they can continue working or studying at night. However, the after-effect is that they will feel tired and lethargic the next day.

Long-term effects of taking caffeine

Regular, heavy use of caffeine (such as more than 4 cups of coffee a day) may eventually cause:

• Osteoporosis
• High blood pressure and heart disease
• Heartburn
• Ulcers
• Difficulty sleeping
• Infertility (in men and women)
• Anxiety
• Depression
• Needing to use more to get the same effect
• Dependence on caffeine ⁴

Caffeine Withdrawal

Giving up caffeine after using it for a long time is challenging because the body has to get used to functioning without it. Withdrawal symptoms usually start within 24 hours after the last dose – or even within 6 hours for people who consume a lot of caffeine regularly. The symptoms can last for around 36 hours, or even longer for people who consume a lot.

These symptoms can include:

• Headache
• Tiredness
• Sweating
• Muscle pains
• Anxiety and tension ⁵

Caffeine Overdose

If a large amount of caffeine is consumed it could also cause an overdose. If you experience any of the following effects, call an ambulance straight away by dialing your local emergency number.

• Tremors
• Nausea and vomiting
• Very fast and irregular heart rate
• Confusion and panic attack
• Seizures ⁶

It’s possible to die from having too much caffeine, but this is extremely rare. This would usually only happen if 5–10g of caffeine (or 80 cups of strong coffee) were consumed one after the other ⁴.

In small children, caffeine poisoning can happen if a lower amount, such as around 1g of caffeine (equal to around 12 energy drinks) is consumed one after the other ⁷.

How much caffeine in Midol

• Midol: Acetaminophen 500 mg + Caffeine 60 mg + Pyrilamine maleate 15 mg

In comparison a typical 8 ounce (236 ml) serving of brewed coffee contains at least 95-100mg of caffeine.

If you’re pregnant, limit the amount of caffeine you have to 200 milligrams (mg) a day. This is about the same as 2 x 8 ounce (236 ml) of instant coffee.

High levels of caffeine in pregnancy can result in babies having a low birthweight, which can increase the risk of health problems in later life. Too much caffeine can also cause a miscarriage.

Pyrilamine maleate

Pyrilamine maleate is a histamine H1 antagonist that is often used as an antihistaminergic agent in over-the-counter cold medications ⁸. Pyrilamine maleate selectively binds to but do not activate histamine H1 receptors, thereby blocking the actions of endogenous histamine. When you come into contact with something you have an allergy to, such as pollen, animal hair or fur, house dust or insect bites, your body produces a chemical called histamine. Histamine is a chemical that’s released by Mast cells in your body when an allergen is encountered that can produce symptoms of sneezing, hives, itching, watery eyes, and runny nose, also known as hypersensitivity reactions. Usually histamine is a useful substance but in an allergic reaction it causes unpleasant symptoms including itchy, watery eyes, running or blocked nose, sneezing and skin rashes. Pyrilamine maleate blocks the effects of histamine and so reduces these symptoms. Pyrilamine maleate acts in the bronchi, capillaries, and some other smooth muscles, and are used to prevent or allay motion sickness, seasonal rhinitis, and allergic dermatitis and to induce somnolence. The effects of blocking central nervous system H1 receptors are not as well understood. Pyrilamine maleate has mild hypnotic properties and some local anesthetic action and is used for allergies (including skin eruptions) both parenterally and locally. Pyrilamine maleate is also used to induce sleep, prevent sleeplessness, or treat sleep initiation and maintenance disorders. Pyrilamine maleate is a common ingredient of cold remedies.

Alcohol can increase the nervous system side effects of pyrilamine such as dizziness, drowsiness, and difficulty concentrating. Some people may also experience impairment in thinking and judgment. You should avoid or limit the use of alcohol while being treated with pyrilamine. Do not use more than the recommended dose of pyrilamine, and avoid activities requiring mental alertness such as driving or operating hazardous machinery until you know how the medication affects you. Talk to your doctor or pharmacist if you have any questions or concerns.

Midol Important Information

What do I need to tell my doctor before I take Midol?

• If you have an allergy to acetaminophen, caffeine, salicylamide, or any other part of Midol Complete (acetaminophen, caffeine, and pyrilamine).
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.

What are some things I need to know or do while I take Midol?

• Tell all of your health care providers that you take Midol Complete (acetaminophen, caffeine, and pyrilamine). This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how Midol Complete (acetaminophen, caffeine, and pyrilamine) affects you.
• Do not take more than what your doctor told you to take. Taking more than you are told may raise your chance of very bad side effects.
• Do not take Midol Complete (acetaminophen, caffeine, and pyrilamine) for longer than you were told by your doctor.
• Avoid other sources of acetaminophen. Check labels closely. Too much acetaminophen may cause problems.
• This medicine has acetaminophen in it. Very bad and sometimes deadly liver problems like the need for a liver transplant have happened with acetaminophen use. Most of the time, liver problems have happened in people taking more than 4,000 milligrams of acetaminophen in a day. Also, people who had liver problems were often using more than 1 drug that had acetaminophen in it. Talk with your doctor.
• Call your doctor right away if you take more than 4,000 mg (milligrams) of acetaminophen in a day, even if you feel well.
• Avoid drinking alcohol while taking Midol Complete (acetaminophen, caffeine, and pyrilamine).
• Talk with your doctor before you use other drugs and natural products that slow your actions.
• Limit your use of caffeine (for example, tea, coffee, cola) and chocolate. Use with Midol Complete (acetaminophen, caffeine, and pyrilamine) may cause nervousness, shakiness, and a fast heartbeat.
• If you are taking warfarin, talk with your doctor. You may need to have your blood work checked more closely while you are taking it with Midol Complete (acetaminophen, caffeine, and pyrilamine).
• This medicine may affect certain lab tests. Be sure your doctor and lab workers know you use Midol Complete (acetaminophen, caffeine, and pyrilamine).
• Use with care in children. Talk with the doctor.
• Do not give Midol Complete (acetaminophen, caffeine, and pyrilamine) to a child younger than 12 years old without first checking with the doctor.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Midol Complete (acetaminophen, caffeine, and pyrilamine) while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Midol Complete (acetaminophen, caffeine, and pyrilamine) with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

Liver warning

This product contains acetaminophen. Severe liver damage may occur if you take:

• more than 6 caplets in 24 hours, which is the maximum daily amount for this product
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while using this product

Do NOT use

• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
• if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have:

• liver disease
• glaucoma
• difficulty in urination due to enlargement of the prostate gland
• a breathing problem such as emphysema or chronic bronchitis

Ask a doctor or pharmacist before use if you are:

• taking the blood thinning drug warfarin
• taking sedatives or tranquilizers

When using Midol:

• you may get drowsy
• avoid alcoholic drinks
• excitability may occur, especially in children
• alcohol, sedatives, and tranquilizers may increase drowsiness
• be careful when driving a motor vehicle or operating machinery
• limit the use of caffeine-containing medications, foods, or beverages because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heartbeat. The recommended dose of this product contains about as much caffeine as a cup of coffee.

Stop use and ask a doctor if:

• new symptoms occur
• redness or swelling is present
• pain gets worse or lasts more than 10 days
• fever gets worse or lasts more than 3 days

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

What does Midol do

Midol is used for the temporary relief of these symptoms associated with menstrual periods:

• cramps
• bloating
• water-weight gain
• headache
• backache
• muscle aches
• fatigue

How is Midol best taken?

Use Midol Complete (acetaminophen, caffeine, and pyrilamine) as ordered by your doctor. Read all information given to you. Follow all instructions closely.

Take with or without food. Take with food if it causes an upset stomach.

How often can you take Midol Complete?

• do not take more than the recommended dose
• Adults and children 12 years and older:
  • take 2 caplets with water
  • repeat every 6 hours, as needed
  • do not exceed 6 caplets per day
• Children under 12 years: consult a doctor

What do I do if I miss a dose?

• If you take Midol Complete (acetaminophen, caffeine, and pyrilamine) on a regular basis, take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.
• Many times Midol Complete (acetaminophen, caffeine, and pyrilamine) is taken on an as needed basis. Do not take more often than told by the doctor.

How long does Midol last?

Midol Complete lasts about 6 hours.

Midol dosage

Midol Complete

Active ingredients (in each caplet): Acetaminophen 500 mg (Pain reliever) + Caffeine 60 mg (Diuretic) + Pyrilamine maleate 15 mg (Antihistamine)

Inactive ingredients: carnauba wax, croscarmellose sodium, FD&C blue #2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, propylene glycol, shellac, titanium dioxide, triacetin

Liver warning

This product contains acetaminophen. Severe liver damage may occur if you take:

• more than 6 caplets in 24 hours, which is the maximum daily amount for this product
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while using this product

Allergy Alert

• acetaminophen may cause severe skin or severe allergic reactions. Symptoms may include:
  • skin reddening
  • blisters
  • rash
  • hives
  • facial swelling
  • asthma (wheezing)
  • shock

If a skin or general allergic reaction occurs, stop use and seek medical help right away.

Do NOT use

• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
• if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have:

• liver disease
• glaucoma
• difficulty in urination due to enlargement of the prostate gland
• a breathing problem such as emphysema or chronic bronchitis

Ask a doctor or pharmacist before use if you are:

• taking the blood thinning drug warfarin
• taking sedatives or tranquilizers

When using this product:

• you may get drowsy
• avoid alcoholic drinks
• excitability may occur, especially in children
• alcohol, sedatives, and tranquilizers may increase drowsiness
• be careful when driving a motor vehicle or operating machinery
• limit the use of caffeine-containing medications, foods, or beverages because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heartbeat. The recommended dose of this product contains about as much caffeine as a cup of coffee.

Stop use and ask a doctor if:

• new symptoms occur
• redness or swelling is present
• pain gets worse or lasts more than 10 days
• fever gets worse or lasts more than 3 days

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Midol Complete Directions of use

• Do not take more than the recommended dose
• Adults and children 12 years and older:
  • take 2 caplets with water
  • repeat every 6 hours, as needed
  • do not exceed 6 caplets per day
• Children under 12 years: Ask a doctor

Midol Caffeine Free

Active ingredients (in each caplet): Acetaminophen 500 mg (Pain reliever) + Pamabrom 25 mg (Diuretic)

Pamabrom is a diuretic (water pill). It works by increasing urination.

Pamabrom is used to treat bloating, swelling, feelings of fullness, and other signs of water weight gain related to menstrual symptoms.

Inactive ingredients: carnauba wax, croscarmellose sodium, D&C red #7 calcium lake, FD&C blue #2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, propylene glycol, shellac, titanium dioxide, triacetin

Midol Caffeine Free Uses

For the temporary relief of these symptoms associated with menstrual periods:

• cramps
• bloating
• water-weight gain
• headache
• backache
• muscle aches

What are some things I need to know or do while I take Midol Caffeine Free?

• Tell all of your health care providers that you take Midol Caffeine Free (acetaminophen and pamabrom). This includes your doctors, nurses, pharmacists, and dentists.
• Avoid other sources of acetaminophen. Check labels closely. Too much acetaminophen may cause problems.
• This medicine has acetaminophen in it. Very bad and sometimes deadly liver problems like the need for a liver transplant have happened with acetaminophen use. Most of the time, liver problems have happened in people taking more than 4,000 milligrams of acetaminophen in a day. Also, people who had liver problems were often using more than 1 drug that had acetaminophen in it. Talk with your doctor.
• Call your doctor right away if you take more than 4,000 mg (milligrams) of acetaminophen in a day, even if you feel well.
• Talk with your doctor before you drink alcohol.
• If you are taking warfarin, talk with your doctor. You may need to have your blood work checked more closely while you are taking it with Midol Caffeine Free (acetaminophen and pamabrom).
• This medicine is not approved for use in children younger than 12 years old. Talk with the doctor.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Midol Caffeine Free (acetaminophen and pamabrom) while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

Liver warning

This product contains acetaminophen. Severe liver damage may occur if you take:

• more than 6 caplets in 24 hours, which is the maximum daily amount for this product
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while using this product

Allergy Alert

• acetaminophen may cause severe skin or severe allergic reactions. Symptoms may include:
  • skin reddening
  • blisters
  • rash
  • hives
  • facial swelling
  • asthma (wheezing)
  • shock

If a skin or general allergic reaction occurs, stop use and seek medical help right away.

Do NOT use

• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
• if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have:

• liver disease
• glaucoma
• difficulty in urination due to enlargement of the prostate gland
• a breathing problem such as emphysema or chronic bronchitis

Ask a doctor or pharmacist before use if you are:

• taking the blood thinning drug warfarin
• taking sedatives or tranquilizers

When using this product:

• you may get drowsy
• avoid alcoholic drinks
• excitability may occur, especially in children
• alcohol, sedatives, and tranquilizers may increase drowsiness
• be careful when driving a motor vehicle or operating machinery
• limit the use of caffeine-containing medications, foods, or beverages because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heartbeat. The recommended dose of this product contains about as much caffeine as a cup of coffee.

Stop use and ask a doctor if:

• new symptoms occur
• redness or swelling is present
• pain gets worse or lasts more than 10 days
• fever gets worse or lasts more than 3 days

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Midol Caffeine Free Directions of use

• Do not take more than the recommended dose
• Adults and children 12 years and older:
  • take 2 caplets with water
  • repeat every 6 hours, as needed
  • do not exceed 6 caplets per day
• Children under 12 years: Ask a doctor

What do I do if I miss a dose?

• If you take Midol Caffeine Free (acetaminophen and pamabrom) on a regular basis, take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.
• Many times Midol Caffeine Free (acetaminophen and pamabrom) is taken on an as needed basis. Do not take more often than told by the doctor.

What are some side effects that I need to call my doctor about right away?

Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
• A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.

Other side effects of Midol Caffeine Free

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if you have any side effects that bother you or do not go away.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

Midol Long Lasting Relief

Active ingredients (in each caplet): Acetaminophen 650 mg (Pain reliever)

Inactive ingredients: carnauba wax, colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycolpolysorbate 80, povidone, pregelatinized starch, stearic acid, titanium dioxide

Midol Long Lasting Relief Uses

Temporarily relieves minor aches and pains due:

• Temporarily relieves minor aches and pains due to:
  • the common cold
  • headache
  • backache
  • minor pain of arthritis
  • toothache
  • muscular aches
  • premenstrual and menstrual cramps
• Temporarily reduces fever

Liver warning

The product contains acetaminophen. Severe liver damage may occur if you take:

• more than 6 caplets in 24 hours, which is the maximum daily amount
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while using this product

Ask a doctor before use if you have liver disease.

Allergy Alert

Acetaminophen may cause severe skin reactions.

Symptoms may include:

• skin reddening
• blisters
• rash

If a skin reaction occurs, stop use and seek medical help right away.

Do NOT use

• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. If you are not sure whether a drug contains acetaminophen, as a doctor or pharmacist.
• If you are allergic to acetaminophen or any of the inactive ingredients in this product.

Stop use and ask a doctor if:

• pain gets worse or lasts more than 10 days
• fever gets worse or lasts more than 3 days
• new symptoms occur
• redness or swelling is present

These could be signs of a serious condition

As a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.

If pregnant or breast-feeding, ask a health professional before use.

Midol Long Lasting Relief Directions of use

• Do not take more than the recommended dose
• Adults and children 12 years and older:
  • take 2 caplets every 8 hours with water
  • swallow whole; do not crush, chew, split or dissolve
  • do not take more than 6 caplets in 24 hours
  • do not use for more than 10 days unless directed by a doctor
• Children under 12 years: Ask a doctor

Midol side effects

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Feeling sleepy.
• Feeling nervous and excitable.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

Rare side effects

Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
• Not able to pass urine or change in how much urine is passed.
• A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.

Midol Overdose

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can’t be awakened, immediately call your local emergency services number.

This is a free and confidential service. All local poison control centers in the United States use this national number. You should call if you have any questions about poisoning or poison prevention. You can call 24 hours a day, 7 days a week.

References

1. Food Regulation Standing Committee, Caffeine Working Group. (2013). The regulation of caffeine in foods.
2. Upfal, J. (2006). The Australian drug guide. (7th ed.). Melbourne: Black Inc.
3. Seifer, S., Schaechter, J., Hershorin, E. & Lepshultz, S. (2011). Health effects of energy drinks on children, adolescents, and young adults. Pediatrics, 127(3). 511–528. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3065144/
4. Brands, B., Sproule, B., & Marshman, J. (Eds.). (1998). Drugs & drug abuse (3rd ed.). Ontario: Addiction Research Foundation.
5. American Psychiatric Association. (2013). Diagnostic and Statistical Manual of Mental Disorders. (5th ed). Washington: American Psychiatric Publishing.
6. NPS Medicinewise. (2013). https://www.nps.org.au/news#Information
7. Arria, A., Calderia, K., Kasperski, S., O’Grady, K., Vincent, K., Griffiths, R. & Wish, E. (2010). Increased alcohol consumption, nonmedical prescription drug use, and illicit drug use are associated with energy drink consumption among college students. Journal of Addiction Medicine, 4(2). 74–80. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2923814/
8. Pyrilamine maleate. https://pubchem.ncbi.nlm.nih.gov/compound/pyrilamine_maleate

What is Colace

Colace is an emollient laxative medicine that is used to treat constipation (difficulty pooing). Colace contains the active ingredient Docusate. Colace (Docusate) helps to soften your poo (stool softener) and makes your bowel movements easier to pass.

Colace (Docusate) is used to treat or prevent constipation, and to reduce pain or rectal damage caused by hard stools or by straining during bowel movements. Colace (Docusate) may also be used for purposes not listed in this medication guide.

Colace (Docusate) is helpful when you have difficulty going to the toilet because of dry poos or piles (hemorrhoids) or if you have a tear in the lining of your back passage (an anal fissure). Colace (Docusate) makes your bowel movements softer and easier to pass.

You may also be given Colace (Docusate) if you’re going to have an x-ray of your stomach. It can help you empty your bowels beforehand.

Colace (Docusate) comes as capsules and as a liquid that you swallow. Colace (Docusate) also comes as an enema – a tube of liquid medicine which you squeeze into your back passage.

Colace (Docusate) is available on prescription. You can also buy it from pharmacies.

Key facts

• Colace (Docusate) capsules and liquid take 1 or 2 days to work.
• The Colace (Docusate) enema usually works within 20 minutes – so it’s best to stay close to a toilet.
• Do not give Colace (Docusate) to a child under 12 years old unless their doctor prescribes it.
• Do not take Colace (Docusate) for more than a week without talking with your doctor.
• Docusate is also known by the brand names Surfak, Dulcoease, Dioctyl,Diocto, Dioeze, Doc-Q-Lace, Docu, Docu Soft, Doculase, Docuprene, Docusil, Docusoft S, DocuSol, DOK, DSS, Dulcolax Stool Softener, Enemeez Mini, Kao-Tin, Octycine-250, Pedia-Lax Stool Softener, Phillips Stool Softener, Promolaxin, Silace, Surfak Stool Softener, Sur-Q-Lax, Vacuant. The enema is known by the brand name Norgalax.

Colace mechanism of action

Colace (Docusate) stool softener (emollient laxative) encourages bowel movements by helping water and fats to get into the stool and prevent dry, hard stool masses. This type of laxative has been said to allow patient to have a bowel movement without straining.

Colace (Docusate) is not a stimulant laxative.

How long does it take for Colace to work?

Colace (Docusate) capsules and liquid normally take 1 or 2 days to work. The enema usually works within 20 minutes, so it’s best to stay close to a toilet.

Talk to your doctor or pharmacist if you are still constipated after a week.

How long should I take Colace for?

Take Colace (Docusate) for up to 1 week. If you take Colace (Docusate) for longer, your bowel can start to rely on it, rather than working on its own.

If you are still constipated after taking Colace (Docusate) for a week, talk to your doctor.

If your constipation is caused by an illness or a medicine you’re taking, your doctor will advise you about when it’s best to stop taking Colace (Docusate).

Is it safe to take Colace for a long time?

Ideally, you should only use Colace (Docusate) occasionally and for a few days at a time.

Using laxatives like Colace (Docusate) for longer can lead to long term diarrhea. They can also cause an electrolyte imbalance. This means that levels of substances like sodium, potassium and magnesium in your body get too high or too low. A severe electrolyte imbalance can cause serious health problems such as muscle spasm and twitching, and even fits (convulsions).

Using Colace (Docusate) for many weeks, even months, could also stop your bowel working properly on its own.

Can I take different laxatives together?

For most people, 1 laxative will be enough to relieve constipation.

Occasionally, you may need to take 2 different types of laxatives at the same time to get your bowels moving again.

Only take 2 laxatives together on the advice of your doctor or pharmacist as there is an increased risk of side effects.

Are other laxatives any better?

There are other types of laxative. They work in a different way to Colace (Docusate) but are equally good at treating constipation.

• Bulk-forming laxatives, for example Fybogel and methylcellulose. These increase the ‘bulk’ or weight of poo which in turn stimulates bowel movement. They take 2 or 3 days to work.
• Osmotic laxatives, for example lactulose. These draw water from the rest of the body into your bowel to soften your poo and make it easier to pass. They take at least 2 days to work.
• Stimulant laxatives, for example senna. These stimulate the muscles that line your gut, helping them to move poo along your gut to your back passage. Senna takes about 8 hours to work.

Is there any food and drink I need to avoid?

You can eat and drink normally while taking Colace (Docusate).

It might be a good idea to stop eating pastries, puddings, sweets, cheese and cake for a while as these foods can make constipation worse.

Can I drink alcohol with Colace?

Yes, you can drink alcohol with Colace (Docusate).

Can I use Colace after surgery?

It’s quite common to have constipation after surgery. Using a laxative may help relieve the discomfort.

If you have constipation after an operation, it’s better to use lactulose because it is gentler than Colace (Docusate). You can get it from pharmacies.

Can lifestyle changes help constipation?

It’s often possible to improve constipation without having to use laxatives. Before trying Colace (Docusate) – or to stop constipation coming back – it may help to:

• eat more fiber – aim for about 30-35 g of fiber a day. High-fiber foods include fruit, vegetables and cereals. If you’re not used to a high-fiber diet, increase the amount of fiber you eat gradually.
• add bulking agents, such as wheat bran, to your diet. These will help make your poo softer and easier to pass (although bran and fiber can sometimes make bloating worse).
• drink plenty of water – to keep poo soft
• exercise regularly – keeping your body active will help to keep your gut moving

Who can and can’t take Colace

Most adults can safely take Colace (Docusate), but do not give it to a child under 12 years old unless their doctor prescribes it.

• Never give Colace (Docusate) to a child under 12 years old unless their doctor prescribes it.

Colace (Docusate) isn’t suitable for some people. To make sure it is safe for you, tell your doctor or pharmacist if you have:

• ever had an allergic reaction to Colace (Docusate) or any other medicines in the past
• ever had an allergic reaction to fructose or sorbitol (types of sugar)
• a blockage in your gut (intestine)
• chronic stomach pain that has not been checked by a doctor
• nausea, vomiting, or severe stomach pain
• stomach pains
• been feeling sick in the last 24 hours or have been sick
• been taking a mineral oil laxative such as liquid paraffin

Ask a doctor or pharmacist if it is safe for you to take Colace (Docusate):

• if you are on a low-salt diet; or
• if you have recently had a sudden change in your bowel habits lasting for longer than 2 weeks.

Do not use an enema containing Colace (Docusate) if you have:

• piles (hemorrhoids) or bleeding from your back passage
• sores around your back passage called anal fissures
• illnesses where your bowel or back passage become inflamed such as ulcerative colitis or Crohn’s disease
• ileus – when the muscles in your bowel aren’t able to move food and liquid along

Pregnancy and breastfeeding

Tell your pharmacist or doctor if you’re trying to get pregnant, are already pregnant or if you’re breastfeeding.

FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

It is not known whether Colace (Docusate) will harm an unborn baby. Do not use this medicine without a doctor’s advice if you are pregnant.

Colace (Docusate) may not be suitable if you’re pregnant or breastfeeding because small amounts might be absorbed by your gut.

If you’re pregnant or breastfeeding, it’s always better to try to treat constipation without taking a medicine. Your doctor or midwife will first advise you to eat more fiber and drink plenty of fluids. It may also help to do gentle exercise.

If diet and lifestyle changes don’t work, your doctor or midwife may recommend a laxative, such as lactulose or Fybogel. These are safer laxatives to take during pregnancy and while breastfeeding.

I just found out I am pregnant. Should I stop taking Colace?

You should always talk with your health care provider before making any changes in your medication. It is important to consider the benefits of treating constipation symptoms during pregnancy. Your health care provider may also want to confirm diagnosis of constipation and see how dietary and other lifestyle therapies may help.

Can use of Colace during pregnancy cause birth defects?

Few studies have been done to look at the possible risks of Colace (Docusate) during pregnancy. However, the available studies show that when used in recommended doses Colace (Docusate) is not expected to increase the chance of birth defects.

In every pregnancy, a woman starts out with a 3-5% chance of having a baby with a birth defect. This is called her background risk.

What if the father of the baby takes Colace?

There are no studies looking at possible problems with conceiving or risks to a pregnancy when the father takes Colace (Docusate). In general, exposures that fathers have are unlikely to increase risks to a pregnancy.

What are the dangers of taking too much Colace sodium?

When used in recommended doses, Colace (Docusate) is unlikely to cause problems during pregnancy. However, when more than the recommended amount of this product is used, it can lower the levels of magnesium in a person’s blood. There is one reported case of low magnesium levels in a newborn that was linked to the mother overusing Colace (Docusate). The baby’s main symptom was jitteriness, which went away by the second day of life. There have been no reported problems linked to the use of recommended levels of Colace (Docusate) in pregnancy.

Colace and breastfeeding

It is not known whether Colace (Docusate) passes into breast milk or if it could harm a nursing baby. Do not use this medicine without a doctor’s advice if you are breast-feeding a baby.

While some of the Colace (Docusate) is absorbed by the mother, the amount that passes into milk is likely low ¹. There have been no reports of problems in babies that are breastfeeding while the mother is taking Colace (Docusate). Be sure to talk to your health care provider about all your choices for breastfeeding.

In a randomized, blinded trial, 35 postpartum breastfeeding patients received a laxative containing docusate in a dose of 120 mg daily in addition to danthron 100 mg daily. One patient stated that diarrhea occurred in her breastfed infant ². The diarrhea was most likely caused by the danthron. Danthron is a reddish, synthetic anthraquinone derivative ³. Danthron has been widely used as a laxative, but is no longer used to treat constipation and is currently used as an antioxidant in synthetic lubricants, in the synthesis of experimental antitumor agents, as a fungicide and as an intermediate for making dyes.

If diet and lifestyle changes don’t work, your doctor or midwife may recommend a laxative, such as lactulose or Fybogel. These are safer laxatives to take during pregnancy and while breastfeeding.

Cautions with other medicines

Do not take docusate with a mineral oil laxative such as liquid paraffin.

What is Colace used for

Colace (Docusate) is used to treat or prevent constipation, and to reduce pain or rectal damage caused by hard stools or by straining during bowel movements. Colace (Docusate) may also be used for purposes not listed in this medication guide.

Colace (Docusate) is helpful when you have difficulty going to the toilet because of dry poos or piles (hemorrhoids) or if you have a tear in the lining of your back passage (an anal fissure). Colace (Docusate) makes your bowel movements softer and easier to pass.

You may also be given Colace (Docusate) if you’re going to have an x-ray of your stomach. It can help you empty your bowels beforehand.

• Ask a doctor before use if you notice a sudden change in bowel habits that persists over a period of 2 weeks.
• Stop use and ask a doctor if you have rectal bleeding or you fail to have a bowel movement after use.
• If pregnant or breast-feeding, ask a health professional before use.
• Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Colace vs Dulcolax

Dulcolax contains the active ingredient Bisacodyl, is a laxative that stimulates bowel movements. Bisacodyl acts by directly stimulating the nerve endings in the mucosa of the colon, increasing the movement of the intestines.

Dulcolax (Bisacodyl) is used to treat constipation or to empty the bowels before surgery, colonoscopy, x-rays, or other intestinal medical procedure. Dulcolax (Bisacodyl) tablets generally produce a bowel movement in 6 to 12 hours.

Dulcolax (Bisacodyl) is used in hospitals to help you empty your bowels before surgery or some examinations or treatments. Your hospital will explain how to use it.

Dulcolax (Bisacodyl) comes as a tablet and a suppository (a medicine that you push gently into your back passage).

The tablets and suppositories are available on prescription and to buy from pharmacies.

Dulcolax (Bisacodyl) may be given as follows:

• Usual Adult Dose for Constipation
  • 5 to 15 mg (1 to 3 tablets) orally once a day as needed or
  • 10 mg (1 suppository) rectally once a day as needed or
  • 10 mg rectal liquid once a day as needed.
• Usual Adult Dose for Bowel Preparation
  • 5 to 15 mg (1 to 3 tablets) orally once a day as needed or
  • 10 mg (1 suppository) rectally once a day as needed or
  • 10 mg rectal liquid once a day as needed.

Elderly patients taking Dulcolax (Bisacodyl) have an increased risk of fecal incontinence.

Dulcolax (Bisacodyl) can be used during lactation however, it should only be used occasionally during pregnancy

The onset of action of Dulcolax (Bisacodyl) is as follows:

• Oral: 6-12 hours
• Suppository: 15-60 minutes
• Enema: 5-15 minutes

How and when to take Colace

Colace (Docusate) comes as capsules, liquid and an enema.

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

• Do not crush, chew, break, or open a Colace (Docusate) capsule or tablet. Swallow it whole.
• Colace (Docusate) should generally be used for a period of less than 1 week. For longer than one week see your doctor for advice.
  

Take this medicine with a full glass of water. Drink plenty of liquids while you are taking Colace (Docusate).

Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one. Mix the liquid with 6 to 8 ounces of milk, fruit juice, or infant formula and drink the mixture right away.

After taking Colace (Docusate) by mouth (tablets, capsules, liquid), you should have a bowel movement within 12 to 72 hours.

• Do not take Colace (Docusate) Rectal Enema by mouth. It is for use only in your rectum.

Wash your hands before and after using Colace (Docusate) enema.

Try to empty your bowel and bladder just before using the enema. Remove the cap from the enema applicator tip. Lie down on your left side with your knees bent, and gently insert the tip of the enema applicator into the rectum. Squeeze the tube to empty the entire contents into the rectum. Throw away the tube, even if there is still some medicine left in it. For best results, hold in the enema for as long as possible, or until you have a bowel movement.

The rectal enema should produce a bowel movement within 2 to 15 minutes.

Do not use Colace (Docusate) for longer than 7 days unless your doctor has told you to. Call your doctor if your symptoms do not improve, or if you have not had a bowel movement within 1 to 3 days. Overuse of a stool softener can lead to serious medical problems.

Store at room temperature away from moisture and heat.

How to take Colace

• Capsules – swallow the capsule whole with plenty of water.
• Liquid – this comes with a plastic cup or spoon to measure the dose. Do not use a kitchen spoon as it will not give the right amount. If you don’t have a cup or spoon, ask your pharmacist for one. When you’ve swallowed it, drink plenty of water or another drink, such as milk or orange juice.
• Enema – squeeze the tube of liquid gently into your back passage. The information leaflet which comes with your Colace (Docusate) will explain how to do this.

Colace (Docusate) doesn’t usually upset your tummy. You can take the capsules or liquid with or without food. Try to take them at regular intervals throughout the day. Mealtimes (breakfast, lunch and dinner) are useful reminders.

There is no specific time of day to use an enema but it works quickly (usually between 5 and 20 minutes), so use it when you know you’ll be near a toilet.

How much to take

• Capsules – the normal dose is 1 capsule 3 times a day. Do not take more than 5 capsules in a day.
• Liquid – the normal dose is 2 or 3 x 5ml spoonfuls. Take this dose 3 times a day.
• Enema – normally 1 tube of liquid is all you need. If you need a second dose, you can use it later in the day or the next day.

You should feel more comfortable within 1 or 2 days of treatment. Reduce the dose as your condition gets better.

Drink plenty of fluids (6 to 8 glasses a day) while you are taking Colace (Docusate) or your constipation may get worse.

Usual Adult Dose for Constipation

• Oral: 50 to 400 mg (using any of the salt forms) orally administered in 1 to 4 equally divided doses each day.
• Rectal: 200 to 283 mg rectally administered as an enema once or twice.
• Alternative: 50 to 100 mg (docusate sodium liquid) added to a retention or flushing enema once a day.

Usual Pediatric Dose for Constipation

• Oral:
  • less than 3 years: 10 to 40 mg (docusate sodium) orally divided in 1 to 4 doses.
  • 3 to 6 years: 20 to 60 mg (docusate sodium) orally divided in 1 to 4 doses.
  • 6 to 12 years: 40 to 150 mg (docusate sodium) orally divided in 1 to 4 doses.
  • older than 12 years: 50 to 400 mg (using any of the salt forms) orally administered in 1 to 4 equally divided doses each day.
• Rectal:
  • 3 to 18 years: 50 to 100 mg (docusate sodium liquid) added to a retention or flushing enema once a day.
  • Alternative: 200 to 283 mg rectally administered as an enema once daily as needed for constipation.

Renal Dose Adjustments

• Data not available

Liver Dose Adjustments

• Data not available

Kidney Dialysis

• Data not available

What if I forget to take it?

If you forget a dose of Colace (Docusate), don’t worry, just take the next dose as normal.

Never take 2 doses at the same time. Never take an extra dose to make up for a forgotten one.

What if I take too much?

Taking an extra dose of Colace (Docusate) by accident is unlikely to harm you but you should drink lots of water. You may get diarrhoea and stomach pain but this should ease off within a day or two.

If you’re worried, talk to your doctor or pharmacist for advice.

Colace dosage

Colace Regular Strength

Colace Regular Strength Warnings

• Do not use laxative products for longer than 1 week unless told to do so by a doctor.
• Do not use if you are presently taking mineral oil unless told to do so by a doctor.
• Ask a doctor before use if you have:
  • Stomach pain
  • Nausea
  • Vomiting
  • Noticed a sudden change in bowel habits that lasts over two weeks
• Stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition.
• If pregnant or breastfeeding, ask a health professional before use.
• Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Colace Regular Strength Uses

• Treat occasional constipation – including constipation associated with certain medical conditions – safely, gently, and effectively with Colace Capsules.
• For gentle, reliable relief from occasional constipation (irregularity)
• Stimulant-free for comfortable relief
• Generally produces bowel movement in 12 to 72 hours

Colace Regular Strength Directions of Use

• Take only by mouth. May be taken as a single daily dose or in divided doses.
• Adults and children 12 years of age and over: 1 to 3 capsules daily
• Children 2 to under 12 years of age: 1 capsule daily
• Children under 2 years: Ask a doctor

Colace Clear

Colace Clear is a stool softener available in a clear formulation that is dye-free and a lower strength. Use Colace Clear to treat occasional constipation, including constipation associated with certain medical conditions.

• For gentle, reliable relief from occasional constipation (irregularity)
• Stimulant-free for those who have conditions where they should avoid straining
• Dye-free
• Generally produces bowel movement in 12 to 72 hours

Colace Clear Warnings

• Do not use laxative products for longer than 1 week unless told to do so by a doctor.
• Do not use if you are presently taking mineral oil unless told to do so by a doctor.
• Ask a doctor before use if you have:
  • Stomach pain
  • Nausea
  • Vomiting
  • Noticed a sudden change in bowel habits that lasts over two weeks
• Stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition.
• If pregnant or breastfeeding, ask a health professional before use.
• Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Colace Clear Uses

• Treat occasional constipation – including constipation associated with certain medical conditions – safely, gently, and effectively with Colace Capsules.
• For gentle, reliable relief from occasional constipation (irregularity)
• Stimulant-free for comfortable relief
• Generally produces bowel movement in 12 to 72 hours

Colace Regular Strength Directions of Use

• Take only by mouth. May be taken as a single daily dose or in divided doses.
• Adults and children 12 years of age and over: 1 to 6 capsules daily
• Children 2 to under 12 years of age: 1 to 3 capsules daily
• Children under 2 years: Ask a doctor

Colace side effects

Like all medicines, Colace (Docusate) may cause side effects in some people but most people have no side effects or only minor ones.

If you get any of these side effects, talk to your doctor or pharmacist:

• feeling sick
• diarrhea
• stomach cramps
• dizziness, weakness
• gas, bloating, mild diarrhea
• rectal irritation
• sweating

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

These side effects are mild and usually go away after a couple of days.

With the Colace (Docusate) enema sometimes people get a burning or pain around their back passage. Occasionally the wall of the back passage may bleed. This is a reaction to the enema and it should clear up quickly. If the pain or bleeding don’t go away or you are worried about them, talk to your doctor or pharmacist.

Stop using Colace (Docusate) and call your doctor at once if you have:

• pounding heartbeats or fluttering in your chest;
• a light-headed feeling, like you might pass out;
• rectal bleeding or irritation;
• numbness or a rash around your rectum;
• vomiting, severe diarrhea or stomach cramps; or
• continued constipation, or no bowel movement.

Gastrointestinal

Gastrointestinal side effects have included gastrointestinal cramping. Reports of bitter taste and throat irritation have been reported with administration of primarily the syrup and liquid formulations.

Dermatologic

Dermatologic side effects have included rash.

Metabolic

Metabolic side effects have included at least one case report of hypomagnesemia.

Metabolic abnormalities reported include hypomagnesemia in one woman who took docusate chronically throughout her pregnancy. Magnesium levels returned to normal following discontinuation of Colace (Docusate).

Serious side effects

Serious allergic reaction

In rare cases, it’s possible to have a serious allergic reaction to Colace (Docusate).

• A serious allergic reaction is an emergency. Contact a doctor straight away if you think you or someone around you is having a serious allergic reaction.

The warning signs of a serious allergic reaction are:

• getting a skin rash that may include itchy, red, swollen, blistered or peeling skin
• wheezing
• tightness in the chest or throat
• having trouble breathing or talking
• swelling of the mouth, face, lips, tongue or throat

These are not all the side effects of Colace (Docusate). For a full list see the leaflet inside your medicines packet.

How to cope with side effects

What to do about:

• feeling sick – try taking Colace (Docusate) with meals or mixing your dose with some water or fruit juice.
• diarrhea – drink plenty of water or other fluids. It may also help to take an oral rehydration drink to prevent dehydration. You can buy sachets of powder from a pharmacy which you mix with water. Reducing the dose of Colace (Docusate) may also help diarrhea. Don’t take any other medicines to treat diarrhea without speaking to a pharmacist or doctor.
• stomach cramps – if you get stomach cramps, reduce your dose of Colace (Docusate) until it goes away.

References

1. Lewis JH, Weingold AB and the Committee of FDA-Related Matters, American College of Gastroenterology. The use of gastrointestinal drugs during pregnancy and lactation. Am J Gastroenterol. 1985;80:912-23 https://www.ncbi.nlm.nih.gov/pubmed/2864852
2. Greenhalf JO, Leonard HS. Laxatives in the treatment of constipation in pregnant and breast-feeding mothers. Practitioner. 1973;210:259-63 https://www.ncbi.nlm.nih.gov/pubmed/4570522
3. Danthron. https://pubchem.ncbi.nlm.nih.gov/compound/danthron

What is Allegra

Allegra is an antihistamine that relieves the symptoms of allergies. Allegra contain an active ingredient called Fexofenadine, which is known as a non-drowsy antihistamine (a second generation antihistamine). Allegra (Fexofenadine) is much less likely to make you feel sleepy than some other antihistamines. Allegra (Fexofenadine) is a histamine [H1] receptor blocker, it works by blocking the action of histamine, a substance in the body that causes allergic symptoms. When you come into contact with something you have an allergy to, such as pollen, animal hair or fur, house dust or insect bites, your body produces a chemical called histamine. Histamine is a chemical that’s released by Mast cells in your body when an allergen is encountered that can produce symptoms of sneezing, hives, itching, watery eyes, and runny nose, also known as hypersensitivity reactions. Usually histamine is a useful substance but in an allergic reaction it causes unpleasant symptoms including itchy, watery eyes, running or blocked nose, sneezing and skin rashes. Allegra (Fexofenadine) blocks the effects of histamine and so reduces these symptoms.

Allegra (Fexofenadine) is used to treat hay fever (seasonal allergic rhinitis), allergic conjunctivitis (red, itchy eye), itchy throat, eczema and hives of the skin (nettle rash or chronic idiopathic urticaria). Allegra (Fexofenadine) is also used for reactions to insect bites and stings and for some food allergies.

Allegra (Fexofenadine) is known as a non-drowsy antihistamine. It’s less likely to make you feel sleepy than some other antihistamines.

Allegra (Fexofenadine) is available is an over-the- counter (OTC) and also on prescription. It comes as tablets, meltable tablets, capsule and liquid suspension

Key facts

• It’s usual to take Allegra (Fexofenadine) once a day. Children sometimes take it twice a day.
• Allegra (Fexofenadine) is classed as a non-drowsy antihistamine, but some people still find it makes them feel quite sleepy.
• Common side effects include headache, feeling sleepy, dry mouth, feeling sick and dizziness.
• Don’t drink grapefruit juice, apple juice or orange juice while you’re taking Allegra (Fexofenadine). It might make you more likely to get side effects.
• It’s best not to drink alcohol while you’re taking Allegra (Fexofenadine) as it can make you feel sleepy.
• Fexofenadine is also called by the brand name Telfast, Allegra and Allegra ODT

What is Allegra used for?

Allegra (Fexofenadine) is used to relieve the allergy symptoms of seasonal allergic rhinitis (”hay fever”), including runny nose; sneezing; red, itchy, or watery eyes (allergic conjunctivitis); itching of the nose, throat, or roof of the mouth in adults and children 2 years of age and older. It is also used to relieve symptoms of urticaria (hives; red, itchy raised areas of the skin), eczema including itching and rash in adults and children 6 months of age and older.

Allegra (Fexofenadine) is also used for reactions to insect bites, stings, some food allergies and a condition called chronic idiopathic urticaria in adults and children.

Allegra (Fexofenadine) is known as a non-drowsy antihistamine. It’s less likely to make you feel sleepy than some other antihistamines.

How long does it take for Allegra to work?

You should start to feel better within an hour or 2.

What’s the difference between Allegra and other antihistamines?

Allegra (Fexofenadine) is known as a non-drowsy antihistamine. That’s because it’s less likely to make you feel sleepy than other, so-called ‘sedating antihistamines’ such as Benadryl (Diphenhydramine).

Most people prefer to take a non-drowsy antihistamine instead of a sedating one. An exception is when you want the medicine to make you sleepy, for example if you have itchy skin that’s keeping you awake at night.

What’s the difference between Allegra and other non-drowsy antihistamines?

Other non-drowsy antihistamines like acrivastine, cetirizine (Zyrtec), loratadine (Claritin), desloratadine and levocetirizine seem to work just as well as Allegra (Fexofenadine).

However, Allegra (Fexofenadine) seems to be less likely to make you feel sleepy than other non-drowsy antihistamines.

If one non-drowsy antihistamine hasn’t worked for you, it’s worth trying another one.

How long should I take Allegra for?

It depends on why you’re taking Allegra (Fexofenadine).

You may only need to take it as a one-off dose or for a day or 2, for example if you have a reaction to an insect bite.

You may need to take Allegra (Fexofenadine) for longer if you’re taking it to prevent symptoms – for example, to stop hay fever when the pollen count is high.

Talk to your doctor or pharmacist if you’re unsure how long you need to take Allegra (Fexofenadine) for.

Is it safe to take Allegra for a long time?

Allegra (Fexofenadine) is unlikely to do you any harm if you take it for a long time. However, it’s best to take Allegra (Fexofenadine) only for as long as you need to.

Can I drive or ride a bike with Allegra?

Allegra (Fexofenadine) is classed as a non-drowsy antihistamine but it’s still possible to feel sleepy after taking it.

If you’re taking Allegra (Fexofenadine) for the first time, see how it makes you feel before driving, cycling or using heavy machinery or tools.

Does Allegra (Fexofenadine) cause weight gain?

Allegra (Fexofenadine) isn’t known to cause weight gain.

Can I take Allegra with painkillers?

Yes, you can take Allegra (Fexofenadine) together with acetaminophen (Tylenol) or ibuprofen (Motrin).

Can I take more than one antihistamine together?

Sometimes doctors recommend that people with a severe itchy skin rash take 2 different antihistamines together for a few days.

As well as taking a non-drowsy antihistamine during the day such as Allegra (Fexofenadine), Zyrtec (Cetirizine) or Claritin (Loratadine), your doctor may suggest that you take a sedating antihistamine (e.g. Benadryl) at night time if the itch is making it difficult to sleep.

Do not take 2 antihistamines together unless your doctor advises you to.

Can I take Allegra with other hay fever treatments?

Yes, it’s fine to take Allegra (Fexofenadine) together with other hay fever treatments, for example steroid nasal sprays (such as Beconase, Rhinacort Aqua and Flixonase Nasules) or eye drops.

Can I take Allegra at higher doses than on the packet?

Your doctor might suggest you or your child take a higher dose of Allegra (Fexofenadine) (up to 4 times the usual dose) for a severe itchy skin rash or angioedema (swelling underneath the skin).

Taking high doses of Allegra (Fexofenadine) isn’t suitable for everyone. Speak to your doctor if you don’t think Allegra (Fexofenadine) is working for you.

Can lifestyle changes relieve hay fever?

It will help if you don’t spend too much time outside if the pollen count is high.

Tips for when you’re outside:

• Don’t cut grass or walk on grass.
• Wear wraparound sunglasses to stop pollen getting into your eyes.
• Put Vaseline around your nostrils to help trap pollen.
• Shower and change your clothes after you’ve been outside to wash off pollen.

Tips for when you’re inside:

• Keep windows and doors shut as much as possible.
• Vacuum regularly and dust with a damp cloth.
• Don’t keep fresh flowers in the house.
• Don’t smoke or be around smoke as it makes hay fever symptoms worse.

Who can and can’t take Allegra

Allegra (Fexofenadine) tablets can be taken by adults and children aged 6 years and over.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered.

Allegra (Fexofenadine) isn’t recommended for people over 65 years old because there isn’t much research on the medicine in this age group. Talk to your pharmacist or doctor if you’re over 65 and want to take Allegra (Fexofenadine). Elderly patients are more likely to have age-related kidney problems, which may require an adjustment in the dose for patients receiving Allegra (Fexofenadine).

Allegra (Fexofenadine) isn’t suitable for some people. Tell your doctor or pharmacist if you:

• have had an allergic reaction to Allegra (Fexofenadine) or any other medicines in the past. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
• have problems with your liver or kidneys
• have, or have ever had, heart problems
• have epilepsy or another health problem that puts you at risk of seizures
• are booked to have an allergy test – taking Allegra (Fexofenadine) may affect the results, so you might need to stop taking it a few days before the test

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body .
• Phenylketonuria—Use with caution. The oral disintegrating tablets contain phenylalanine .

Pediatric patients

Appropriate studies have not been performed on the relationship of age to the effects of Allegra (Fexofenadine) in children below 6 months of age. Safety and efficacy have not been established.

• Do NOT give Allegra (Fexofenadine) to a child without medical advice.

Do not give any cough and cold medicine to a baby or child under 4 years of age. Using these medicines in very young children might cause serious or possibly life-threatening side effects.

Allegra Drug Interactions

Tell your doctor or pharmacist if you’re taking any other medicines, including herbal remedies, vitamins or supplements.

Some medicines and Allegra (Fexofenadine) interfere with each other and increase the chances of you having side effects. Check with your pharmacist or doctor if you’re taking:

• midodrine, a medicine used to treat low blood pressure
• ketoconazole, a medicine to treat fungal infections
• erythromycin, an antibiotic
• ritonavir or lopinavir, medicines used to treat HIV infection
• rifampicin, an antibiotic
• indigestion remedies containing aluminium or magnesium – leave about 2 hours between the times that you take Allegra (Fexofenadine) and your indigestion remedy
• any medicine that makes you drowsy, gives you a dry mouth, or makes it difficult for you to pee. Taking Allegra (Fexofenadine) might make these side effects worse.

Using Allegra (Fexofenadine) with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Eliglustat
• Simeprevir

Using Allegra (Fexofenadine) with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Aluminum Carbonate, Basic
• Aluminum Hydroxide
• Aluminum Phosphate
• Dihydroxyaluminum Aminoacetate
• Dihydroxyaluminum Sodium Carbonate
• Magaldrate
• Magnesium Carbonate
• Magnesium Hydroxide
• Magnesium Oxide
• Magnesium Trisilicate
• St John’s Wort

Mixing Allegra with herbal remedies and supplements

There might be a problem taking some herbal remedies and supplements alongside Allegra (Fexofenadine) – especially ones that cause sleepiness, a dry mouth or make it difficult to pee.

Ask your pharmacist for advice.

Can I drink alcohol with Allegra?

It’s best not to drink alcohol while you’re taking Allegra (Fexofenadine) as it can make you feel sleepy.

Is there any food or drink I need to avoid?

Don’t drink grapefruit juice, orange juice or apple juice while taking Allegra (Fexofenadine). It might make you more likely to have side effects.

Fruit juices can make it harder for your body to absorb Allegra (Fexofenadine). Do not take Allegra with fruit juice (such as apple, orange, or grapefruit).

What else should I avoid?

Avoid using antacids within 15 minutes before or after taking a medication that contains Allegra. Antacids can make it harder for your body to absorb this medication.

Avoid taking any other cold or allergy medicines unless your doctor has told you to.

Pregnancy and Breastfeeding

For safety, tell your pharmacist or doctor if you’re trying to get pregnant, are already pregnant or if you’re breastfeeding.

Allegra (Fexofenadine) isn’t normally recommended during pregnancy.

FDA pregnancy category C: Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

It is not known whether Allegra (Fexofenadine) will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.

A similar antihistamine called Loratadine (Claritin) is normally used first because there’s more information to say that it’s safer.

Talk to your doctor about the benefits and possible harms of taking Allegra (Fexofenadine). It will also depend on how many weeks pregnant you are and the reason you need to take Allegra (Fexofenadine).

I just found out I am pregnant. Should I stop taking Allegra?

You should always talk with your healthcare provider before making any changes in your medications. It is important to consider the benefits of treating allergy symptoms and other conditions during pregnancy. Treating allergy symptoms may reduce asthma symptoms and the need for additional asthma medicines.

In people who took 60 mg of Allegra (Fexofenadine) twice a day, it could take up to 4 days for all of this medication to leave the body.

I am pregnant. Can use of Allegra during pregnancy cause birth defects?

So far, studies on both Allegra (Fexofenadine) and Terfenadine [terfenadine changes into fexofenadine in the body, so information on terfenadine may also be helpful for predicting the effects of fexofenadine on pregnancy and breastfeeding] have not found an increase in birth defects with use of these medicines ¹, ², ³, ⁴, ⁴, ⁵.

Can Allegra cause a miscarriage?

There are no studies that have looked at whether Allegra (Fexofenadine) can increase the chance for a miscarriage.

Can use of Allegra cause other pregnancy complications?

No studies have looked at whether Allegra (Fexofenadine) could cause other pregnancy complications. A study on Terfenadine [terfenadine changes into fexofenadine in the body, so information on terfenadine may also be helpful for predicting the effects of fexofenadine on pregnancy and breastfeeding] found no increase in premature delivery or low birth weight with use during pregnancy.

Will Allegra affect my fertility?

There’s no evidence that Allegra (Fexofenadine) affects male or female fertility.

Will Allegra affect my contraception?

Allegra (Fexofenadine) doesn’t affect any type of contraception, including the contraceptive pill and the morning after pill.

What if the father of the baby takes Allegra?

There is no evidence that suggests that a man’s Allegra (Fexofenadine) use would cause any problems during his partner’s pregnancy. In general, exposures that fathers have are unlikely to increase risks to a pregnancy.

Allegra (Fexofenadine) and breastfeeding

There’s not a lot of information on the use of Allegra (Fexofenadine) during breastfeeding, and so it’s best not to take it.

• Allegra (Fexofenadine) during breastfeeding is not recommended.

It’s usually safe to take similar antihistamines called Loratadine (Claritin) and Cetirizine (Zyrtec) while you’re breastfeeding.

However, speak to your doctor before taking any antihistamine if your baby was premature, had a low birth weight or has other health problems.

It is not known if fexofenadine hydrochloride is distributed into breast milk ⁶. Since there are no adequate and controlled studies to date on the use of fexofenadine during lactation in humans and because many drugs are excreted in human milk, the manufacturer states that fexofenadine alone or in fixed combination with pseudoephedrine hydrochloride should be used with caution in nursing women, and a decision should be made whether to discontinue nursing or the drug, taking into account the importance of the drug to the woman ⁶.

Allegra (Fexofenadine) is less likely to cause sleepiness in adults than some other antihistamines. For this reason, Allegra (Fexofenadine) may be preferred for breastfeeding over antihistamines that do cause sleepiness. Information from Terfenadine [terfenadine changes into fexofenadine in the body, so information on terfenadine may also be helpful for predicting the effects of fexofenadine on pregnancy and breastfeeding] suggests that the amount of Allegra (Fexofenadine) in the breastmilk is small. One study estimated that a baby that was breastfed by a mother taking Allegra (Fexofenadine) got less than 1% of the mother’s dose ⁷. This dose would be too low to cause problems for the baby.

When 25 women were asked by telephone how their babies were doing while they were taking terfenadine and breastfeeding, three mothers said their babies experienced irritability but that they did not need to take the babies to a healthcare provider ⁸. It is not possible to know if their irritability was caused by terfenadine in breastmilk.

It is possible, but not proven, that antihistamines may lower the amount of milk a woman makes. This might be more likely to occur if antihistamines are used in combination with an oral decongestant like pseudoephedrine or phenylephrine, or if used before beginning to breastfeed.

Be sure to talk to your health care provider about all your breastfeeding questions.

Allegra vs Zyrtec

Zyrtec (Cetirizine) is also classed as a non-drowsy antihistamine medicine that relieves the symptoms of allergies by blocking the effects of the chemical histamine in your body. But Allegra (Fexofenadine) seems to be less likely to make you feel sleepy than Zyrtec (Cetirizine).

Zyrtec’s active ingredient is a compound called Cetirizine (IUPAC name: 2-[2-[4-[(4-chlorophenyl)-phenylmethyl]piperazin-1-yl]ethoxy]acetic acid) which is a non-drowsy antihistamine ⁹. Zyrtec (cetirizine) was the first marketed drug from the series of second-generation antihistamines showing both minimal side effects on the central nervous system and a reduced level of cardiotoxicity ⁹. Zyrtec (cetirizine) is much less likely to make you feel sleepy than some other first generation or older antihistamines.

Zyrtec (cetirizine) is used to treat hay fever or allergy symptoms such as allergic conjunctivitis (red, itchy eye), eczema and hives. It’s also used for reactions to insect bites and stings and for some food allergies and the symptoms of common cold.

How and when to take Allegra

If you or your child have been prescribed Allegra (Fexofenadine), follow your doctor’s instructions about how and when to take it.

Before taking Allegra – Precautions

• tell your doctor and pharmacist if you are allergic to Allegra (Fexofenadine), any other medications, or any of the ingredients in Allegra (Fexofenadine) tablets or suspension. Ask your pharmacist for a list of the ingredients.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention either of the following: erythromycin (E.E.S., E-Mycin, Erythrocin) and ketoconazole (Nizoral). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• if you are taking an antacid containing aluminum or magnesium (Maalox, Mylanta, others), take the antacid a few hours before or after Allegra (Fexofenadine).
• tell your doctor if you have or have ever had kidney disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking Allegra (Fexofenadine), call your doctor.

How should Allegra be used?

Allegra (Fexofenadine) comes as a tablet and a suspension (liquid) to take by mouth. It is usually taken with water once or twice a day. Allegra (Fexofenadine) will work better if it is not taken with fruit juices such as orange, grapefruit, or apple juice. Take Allegra (Fexofenadine) at around the same time(s) every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take Allegra (Fexofenadine) exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Allegra (Fexofenadine) controls the symptoms of seasonal allergic rhinitis and urticaria but does not cure these conditions. Continue to take Allegra (Fexofenadine) even if you feel well and are not experiencing these symptoms. If you wait too long between doses, your symptoms may become worse.

Shake the suspension well before each use to mix the medication evenly.

How much should I take?

Allegra (Fexofenadine) comes as tablets (30mg, 120mg and 180mg).

How much you take depends on why you’re taking Allegra (Fexofenadine):

• For hay fever – the usual dose for adults and children aged 12 years and over is 120mg once a day. The usual dose for children aged 6 to 11 years is 30mg twice a day. In this case, try to space the doses 10 to 12 hours apart.
• For hives (nettle rash) – the usual dose for adults and children aged 12 years and over is 180mg once a day.

Allegra (Fexofenadine) Dosing

The dose of this medicine will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For symptoms of hay fever:

• For oral dosage form (capsules, tablets):
  • Adults and children 12 years of age and older—60 milligrams (mg) two times a day, or 180 mg once a day.
  • Children 6 to 11 years of age—30 mg two times a day.
  • Children 4 to 6 years of age—Use and dose must be determined by your doctor .
  • Children and infants up to 4 years of age—Use is not recommended.
• For oral dosage form (disintegrating tablets):
  • Children 6 to 11 years of age—30 milligrams (mg) two times a day, on an empty stomach.
  • Children 4 to 6 years of age—Use and dose must be determined by your doctor .
  • Children and infants up to 4 years of age—Use is not recommended.
• For oral dosage form (suspension):
  • Children 4 to 11 years of age—30 milligrams (mg) or 5 milliliters (mL) two times a day.
  • Children younger than 4 years of age—Use and dose must be determined by your doctor.

For symptoms of chronic hives:

• For oral dosage form (capsules, tablets):
  • Adults and children 12 years of age and older—60 milligrams (mg) two times a day, or 180 mg once a day.
  • Children 4 to 11 years of age—30 mg two times a day.
  • Children younger than 4 years of age—Use and dose must be determined by your doctor.
• For oral dosage form (disintegrating tablets):
  • Children 4 to 11 years of age—30 milligrams (mg) two times a day, on an empty stomach.
  • Children younger than 4 years of age—Use and dose must be determined by your doctor.
• For oral dosage form (suspension):
  • Children 4 to 11 years of age—30 milligrams (mg) or 5 milliliters (mL) two times a day.
  • Children 6 months to 4 years of age—15 mg or 2.5 mL two times a day.
  • Children younger than 6 months of age—Use and dose must be determined by your doctor.

How to take Allegra

• If you’re taking 30mg Allegra (Fexofenadine) tablets, you can take them with or without food.
• If you’re taking 120mg and 180mg Allegra (Fexofenadine) tablets, take them before a meal.

Always take your Allegra (Fexofenadine) tablets with a drink of water. Swallow them whole – do not chew them.

Do NOT take Allegra (Fexofenadine) with juice such as grapefruit, orange, or apple juice.

You should NOT take antacids that contain aluminum or magnesium hydroxide within 15 minutes of taking this medicine. If you are uncertain about this, ask your doctor or pharmacist .

For patients using the oral disintegrating tablet form of Allegra:

• Make sure your hands are dry.
• Do not push the tablet through the foil backing of the package. Instead, gently peel back the foil backing and remove the tablet.
• Immediately place the tablet on top of the tongue. Do not chew or break the tablet.
• The tablet will dissolve in seconds, and you may swallow it with your saliva. You may drink a glass of water after the tablet has dissolved.
• Always take this tablet on an empty stomach.

Shake the oral liquid well before using it. Measure the liquid with a marked measuring spoon, oral syringe, or medicine cup.

When to take Allegra

You may only need to take Allegra (Fexofenadine) on a day you have symptoms, such as if you’ve been exposed to something you’re allergic to like animal hair. Or you may need to take it regularly to prevent symptoms, such as to stop hay fever during spring and summer.

What if I forget to take it?

If you’re taking Allegra (Fexofenadine) once a day, do not take a double dose to make up for a forgotten dose. Take the next dose at the usual time as prescribed by your doctor.

If you forget doses often, it may help to set an alarm to remind you. You could also ask your pharmacist for advice on other ways to help you remember to take your medicine.

What if I take too much?

Allegra (Fexofenadine) is generally very safe. Taking too much is unlikely to harm you.

If you take an extra dose by mistake, you might get some of the common side effects. If this happens or you’re concerned, contact your doctor.

Allegra dosage

Allegra 12HR

Active ingredient: Fexofenadine HCI 60 mg in each tablet (Antihistamine)

Inactive ingredients: colloidal silicone dioxide, croscarmellose sodium, hypromellose, iron oxide blends, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, titanium dioxide

Other information

• Safety sealed: Do not use if carton is opened or if individual blister units are torn or opened.
• Store between 20˚ and 25˚C (68˚ and 77˚F).
• Protect from excessive moisture.

Allegra 12HR Warnings

Do not use if you have ever had an allergic reaction to this product or any of its ingredients.

Use as directed.

Ask a doctor before use if you have kidney disease. Your doctor should determine if you need a different dose.

When using this product:

• do not take more than directed
• do not take at the same time as aluminum or magnesium antacids
• do not take with fruit juices (see Directions)

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Allegra 12HR Uses

Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

• Runny nose
• Sneezing
• Itchy, watery eyes
• Itching of the nose or throat

Allegra 12HR Directions of Use

• Adults and children 12 years of age and over: Take one 60 mg tablet with water every 12 hours; do not take more than 2 tablets in 24 hours
• Children under 12 years of age: do NOT use
• Adults 65 years of age and older: Ask a doctor
• Consumers with kidney disease: Ask a doctor

Allegra 24HR

Active ingredient: Fexofenadine HCI 180 mg in each tablet (Antihistamine)

Inactive ingredients: colloidal silicone dioxide, croscarmellose sodium, hypromellose, iron oxide blends, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, titanium dioxide

Other information

• Safety sealed: Do not use if carton is opened or if individual blister units are torn or opened.
• Store between 20˚ and 25˚C (68˚ and 77˚F).
• Protect from excessive moisture.

Allegra 24HR Warnings

Do not use if you have ever had an allergic reaction to this product or any of its ingredients.

Use as directed.

Ask a doctor before use if you have kidney disease. Your doctor should determine if you need a different dose.

When using this product:

• do not take more than directed
• do not take at the same time as aluminum or magnesium antacids
• do not take with fruit juices (see Directions)

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Allegra 24HR Uses

Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

• Runny nose
• Sneezing
• Itchy, watery eyes
• Itching of the nose or throat

Allegra 24HR Directions of Use

• Adults and children 12 years of age and over: Take one 180 mg tablet with water once a day; do not take more than 1 tablet in 24 hours.
• Children under 12 years of age: do NOT use
• Adults 65 years of age and older: Ask a doctor
• Consumers with kidney disease: Ask a doctor

Children’s Allegra Liquid

Active ingredient: Fexofenadine HCI 30 mg in each 5 mL teaspoonful (Antihistamine)

Inactive ingredients: butylparaben, edetate disodium, flavor, poloxamer 407, propylene glycol, propylparaben, purified water, sodium phosphate dibasic heptahydrate, sodium phosphate monobasic monohydrate, sucrose, titanium dioxide, xanthan gum, xylitol

Other information

• Each 5 mL teaspoon contains: sodium 18 mg
• Safety sealed: Do not use if carton is opened or if printed foil inner seal on bottle is torn or missing
• Store between 20˚ and 25˚C (68˚ and 77˚F).

Children’s Allegra Liquid Warnings

Do not use if you have ever had an allergic reaction to this product or any of its ingredients.

Use as directed.

Ask a doctor before use if you have kidney disease. Your doctor should determine if you need a different dose.

When using this product:

• do not take more than directed
• do not take at the same time as aluminum or magnesium antacids
• do not take with fruit juices (see Directions)

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Children’s Allegra Liquid Uses

Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

• Runny nose
• Sneezing
• Itchy, watery eyes
• Itching of the nose or throat

Children’s Allegra Liquid Directions of Use

• Shake well before using. Use only with enclosed dosing cup.
• One dose lasts a full 12 hours. See carton for dosing instructions. Use only as directed.
• Adults and children 12 years of age and over: Take 2 teaspoonfuls (10 mL) every 12 hours; do not take more than 4 teaspoonfuls (20 mL) in 24 hours
• Children 2 to under 12 years of age: Take 1 teaspoonful (5 mL) every 12 hours; do not take more than 2 teaspoonfuls (10 mL) in 24 hours
• Children under 2 years of age: Ask a doctor
• Adults 65 years of age and older: Ask a doctor
• Consumers with kidney disease: Ask a doctor

Children’s Allegra Meltable Tablets

Active ingredient: Fexofenadine HCI 30 mg in each tablet (Antihistamine)

Inactive ingredients: aspartame, citric acid anhydrous, crospovidone, flavors, magnesium stearate, mannitol, methacrylic acid copolymer, microcrystalline cellulose, povidone, sodium bicarbonate, sodium starch glycolate

Other information

• Each tablet contains: sodium 3.8 mg
• Phenylketonurics: contains phenylalanine 5.3 mg per tablet
• Safety sealed: Do not use if carton is opened or if individual blister units are torn or opened.
• Store between 20˚ and 25˚C (68˚ and 77˚F).
• Use tablet immediately after opening individual blister.
• Contains lactose.

Children’s Allegra Meltable Tablets Warnings

Do not use if you have ever had an allergic reaction to this product or any of its ingredients.

Use as directed.

Ask a doctor before use if you have kidney disease. Your doctor should determine if you need a different dose.

When using this product:

• do not take more than directed
• do not take at the same time as aluminum or magnesium antacids
• do not take with fruit juices (see Directions)

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Children’s Allegra Meltable Tablets Uses

Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

• Runny nose
• Sneezing
• Itchy, watery eyes
• Itching of the nose or throat

Children’s Allegra Meltable Tablets Directions of Use

• Place 1 tablet on tongue; tablet disintegrates with or without water.
• One dose lasts a full 12 hours. See carton for dosing instructions. Use only as directed.
• Adults and children 12 years of age and over: Take 2 tablets every 12 hours on an empty stomach; do not take more than 4 tablets in 24 hours
• Children 6 to under 12 years of age: Take 1 tablet every 12 hours on an empty stomach; do not take more than 2 tablets in 24 hours
• Children under 6 years of age: Do NOT use
• Adults 65 years of age and older: Ask a doctor
• Consumers with kidney disease: Ask a doctor

Allegra side effects

Like all medicines, Allegra (Fexofenadine) can cause side effects, although not everyone gets them.

Common side effects

Common side effects of Allegra (Fexofenadine) happen in more than 1 in 100 people. Talk to your doctor or pharmacist if these side effects bother you or don’t go away:

• feeling sick
• vomiting
• feeling sleepy
• headache
• dry mouth
• feeling dizzy

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them.

Gastrointestinal

• Very common (10% or more): Vomiting (up to 12%)
• Common (1% to 10%): Nausea, diarrhea, stomach discomfort

Nervous system

• Very common (10% or more): Headache (up to 10.3%)
• Common (1% to 10%): Drowsiness, dizziness, somnolence

Other side effects

• Common (1% to 10%): Otitis media, pyrexia, fatigue, extremity pain

Respiratory

• Common (1% to 10%): Cough, upper respiratory tract infection, rhinorrhea
• Frequency not reported: Dyspnea

Musculoskeletal

• Common (1% to 10%): Back pain

Genitourinary

• Common (1% to 10%): Dysmenorrhea

Psychiatric

• Frequency not reported: Insomnia, nervousness, nightmares, sleep disorders or paroniria/excessive dreaming

Cardiovascular

• Frequency not reported: Palpitations, tachycardia, chest tightness

Hypersensitivity

• Frequency not reported: Hypersensitivity reactions, angioedema, systemic anaphylaxis

Dermatologic

• Frequency not reported: Rash, pruritus, flushing

Less common side effects

• back pain
• body aches or pain
• chills
• coughing
• diarrhea
• difficulty with moving
• dizziness
• ear congestion
• earache
• fever
• headache
• joint pain
• loss of voice
• muscle aching or cramping
• muscle pains or stiffness
• nasal congestion
• nausea
• pain in arms or legs
• pain or tenderness around eyes or cheekbones
• painful menstrual bleeding
• redness or swelling in ear
• ringing or buzzing in ears
• runny or stuffy nose
• sleepiness or unusual drowsiness
• sneezing
• sore throat
• stomach upset
• swollen joints
• unusual feeling of tiredness or weakness
• viral infection (such as cold and flu)

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Rare side effects

• Nervousness
• Rash
• Sleeplessness
• Terrifying dreams
• Trouble sleeping
• Chest tightness
• Feeling of warmth, redness of the face, neck, arms and occasionally, upper chest
• Large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• Shortness of breath, difficult or labored breathing

Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if you have any of the side effects listed above.

Serious side effects

It’s rare to have a serious side effect with Allegra (Fexofenadine).

• Tell your doctor straight away if you have a fast or irregular heartbeat.

Serious allergic reaction

In rare cases, it’s possible to have a serious allergic reaction to Allegra (Fexofenadine).

• A serious allergic reaction is an emergency. Contact a doctor straight away if you think you or someone around you is having a serious allergic reaction.

The warning signs of a serious allergic reaction are:

• getting a skin rash that may include itchy, red, swollen, blistered or peeling skin
• wheezing
• tightness in the chest or throat
• having trouble breathing or talking
• swelling of the mouth, face, lips, tongue, or throat

These are not all the side effects of Allegra (Fexofenadine). For a full list see the leaflet inside your medicines packet.

How to cope with side effects

What to do about:

• feeling sick – stick to simple meals and don’t eat rich or spicy food
• feeling sleepy – try a different non-drowsy antihistamine. If this doesn’t help, talk to your doctor
• headache – take an everyday painkiller like paracetamol or ibuprofen
• dry mouth – chew sugar-free gum or suck sugar-free sweets
• feeling dizzy – lie down until the dizziness passes, then get up slowly. Move slowly and carefully. Avoid coffee, cigarettes, alcohol and recreational drugs. If the dizziness doesn’t get better within a couple of days, speak to your pharmacist or doctor.

Human Toxicity Reports

Safety and efficacy of fexofenadine hydrochloride have not been established in children younger than 6 years of age ⁶.

In clinical trials, dysmenorrhea occurred in 1.5% of patients receivingoral fexofenadine 60 mg twice daily, compared to 0.3% in patients receiving placebo ¹⁰.

In controlled clinical studies in patients 12 years of age and older with allergic rhinitis receiving oral fexofenadine hydrochloride dosages of 60 mg twice daily or placebo, drowsiness or fatigue occurred in 1.3% of patients, compared with 0.9% of those receiving placebo ¹¹. In these studies in patients receiving fexofenadine hydrochloride dosages of 180 mg once daily (as conventional tablets) or placebo, headache was reported in 10.6 or 7.5% of patients, respectively. In controlled studies in children 6-11 years of age with seasonal allergic rhinitis receiving fexofenadine hydrochloride dosages of 30 mg twice daily or placebo, headache was reported in 7.2 or 6.6% of patients, respectively, while pain was reported in 2.4 or 0.4% of patients, respectively ¹¹.

During controlled clinical studies, nausea and dyspepsia were reported in 1.6 and 1.3%, respectively, of patients receiving oral fexofenadine hydrochloride dosages of 60 mg twice daily versus 1.5 and 0.6%, respectively, of those receiving placebo ¹¹.

Rash, urticaria, pruritus, and hypersensitivity reactions including angioedema, chest tightness, dyspnea, flushing, or anaphylaxis have been reported rarely in patients receiving fexofenadine hydrochloride ⁶.

In controlled studies in adults and children 12 years and older with chronic idiopathic urticaria receiving fexofenadine hydrochloride dosages of 60 mg twice daily or placebo, both back pain and sinusitis were reported in 2.2 or 1.1% of patients, respectively ⁶.

Clinical data from over 2000 patients indicate that fexofenadine hydrochloride lacks the cardiotoxic potential of its parent drug terfenadine ¹¹. In 714 patients with seasonal allergic rhinitis, fexofenadine hydrochloride dosages of 60-240 mg twice daily were not associated with statistically significant mean increases in the QT interval corrected for rate (QTc) in controlled clinical studies. In addition, in 231 healthy individuals, fexofenadine hydrochloride dosages of 240 mg given once daily for 1 year also were not associated with statistically significant increases in the mean QTc. Even at dosages exceeding these (e.g., up to 400 mg twice daily for 6 days in 40 patients, up to 690 mg twice daily for about 1 month in 32 patients, up to 800 mg given in a single dose in 87 patients), statistically significant mean increases in the QTc or other ECG abnormalities have not been reported in healthy adults or patients with seasonal allergic rhinitis ¹¹.

Viral infection (eg, cold, influenza) or dysmenorrhea was reported in 2.5 or 1.5% of patients 12 years of age and older receiving fexofenadine hydrochloride in dosages of 60 mg twice daily, respectively. In controlled clinical studies in adults and children 12 years of age and older receiving fexofenadine hydrochloride dosages of 180 mg once daily or placebo, upper respiratory tract infection was reported in 3.2 or 3.1% of patients, respectively, while back pain was reported in 2.8 or 1.4% of patients, respectively ⁶.

In controlled studies in children 6-11 years of age with seasonal allergic rhinitis receiving fexofenadine hydrochloride 30 mg twice daily, upper respiratory tract infection, coughing, accidental injury, fever, and otitis media occurred in 4.3, 3.8, 2.9, 2.4, and 2.4% of children, respectively, while these adverse effects were reported in 1.7, 1.3, 1.3, 0.9, and 0%, respectively, in those receiving placebo ⁶.

To gain insight into possible mechanisms of and predisposing factors for torsades de pointes during terfenadine therapy, spontaneous reports in the US Food and Drug Administration’s Spontaneous Reporting System database were examined ¹². Based on the characteristics of the cases, in vitro cardiac electrophysiologic studies were conducted to test the hypothesis that terfenadine, and not its major metabolite, has actions similar to those of quinidine and is responsible for this form of cardiac toxicity. Spontaneous reports from the general medical community. As of April 1, 1992, 25 cases of torsades de pointes had been reported to the Food and Drug Administration’s Spontaneous Reporting System. Predisposing factors in these cases indicated that the parent drug Terfenadine, but not its metabolite Fexofenadine, may have actions similar those of quinidine that are responsible for inducing arrhythmia ¹². In vitro studies found that terfenadine is equipotent to quinidine as a blocker of the delayed rectifier potassium current in isolated feline myocytes. The metabolite, terfenadine carboxylate, did not inhibit this potassium current even at concentrations 30 times higher than the concentration of terfenadine producing a half-maximal effect. Since blockade of the potassium channel did not occur with the major metabolite of terfenadine, episodes of torsades de pointes are most likely the result of a quinidine-like action of the parent drug and of factors that impair the normally rapid metabolism of terfenadine. Dosage restriction and awareness of the clinical conditions and drug interactions capable of inhibiting the metabolism of terfenadine are essential for prevention of this serious reaction ¹². In controlled trials with approximately 6,000 persons, no case of fexofenadine-associated torsades de pointes was observed. The frequency and magnitude of QTc outliers were similar between fexofenadine HCl and placebo in all studies. Based on a large clinical database, the authors conclude that fexofenadine HCl has no significant effect on QTc, even at doses > 10-fold higher than that is efficacious for seasonal allergic rhinitis ¹³.

Allegra overdose

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. This is a free and confidential service. All local poison control centers in the United States use this national number. You should call if you have any questions about poisoning or poison prevention. It does NOT need to be an emergency. You can call for any reason, 24 hours a day, 7 days a week.

Little information is available regarding toxicity. Clinical effects are anticipated to be an extension of adverse effects reported with therapeutic use. Dizziness, drowsiness, and dry mouth have been reported with fexofenadine overdose.

Symptoms of Allegra overdose may include:

• dizziness
• drowsiness
• dry mouth

References

1. Gilboa SM, et al. 2009. National Birth Defects Prevention Study: Use of antihistamine medications during early pregnancy and isolated major malformations. Birth Defects Res A Clin Mol Teratol 85(2):137-150.
2. Diav-Citrin O, et al. 2003. Pregnancy outcome after gestational exposure to loratadine or antihistamines: a prospective controlled cohort study. J Allergy Clin Immunol 111(6):1239-1243.
3. Kallen B. 2002. Use of antihistamine drugs in early pregnancy and delivery outcome. J Matern Fetal Neonatal Med 11:146-152.
4. Schatz M, Petitti D. 1997. Antihistamines and pregnancy. Ann Allergy Asthma Immunol 78:157-159.
5. Loebstein R, et al. 2000. Pregnancy outcome after gestational exposure to terfenadine: A multicenter, prospective controlled study. Immunology and Allergy Clinics of North America 20(4):807-30.
6. McEvoy, G.K. (ed.). American Hospital Formulary Service. AHFS Drug Information. American Society of Health-System Pharmacists, Bethesda, MD. 2006., p. 34
7. Lucas BD Jr, et al: 1995. Terfenadine pharmacokinetics in breast milk in lactating women. Clin Pharmacol Ther. Apr;57(4):398-402.
8. Ito S, et al. 1993. Prospective follow-up of adverse reactions in breast-fed infants exposed to maternal medication. Am J Obstet Gynecol. 168:1393-9.
9. Handing KB, Shabalin IG, Szlachta K, Majorek KA, Minor W. Crystal structure of equine serum albumin in complex with cetirizine reveals a novel drug-binding site. Molecular immunology. 2016;71:143-151. doi:10.1016/j.molimm.2016.02.003. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4800003/
10. Physicians Desk Reference 60th ed, Thomson PDR, Montvale, NJ 2006., p. 2859
11. McEvoy, G.K. (ed.). American Hospital Formulary Service. AHFS Drug Information. American Society of Health-System Pharmacists, Bethesda, MD. 2006., p. 33
12. Woosley RL et al; JAMA 269 (12): 1532-6, 1993 https://jamanetwork.com/journals/jama/article-abstract/404647
13. Pratt CM et al; Am J Cardiol 83 (10): 1451-4; 1999 https://www.ncbi.nlm.nih.gov/pubmed/10335761

What is Excedrin

Excedrin is a medicine that contains active ingredients in a combination of Acetaminophen (paracetamol), Aspirin, and Caffeine. Acetaminophen is a pain reliever and a fever reducer. Aspirin is acetylsalicylic acid in a group of drugs called salicylates, classified as a non-steroidal anti-inflammatory drug (NSAID). Aspirin works by reducing substances in your body that cause pain, fever, and inflammation. Caffeine is a central nervous system stimulant. Caffeine relaxes muscle contractions in blood vessels to improve blood flow.

Excedrin is used to treat pain caused by tension headaches, migraine headaches, muscle aches, menstrual cramps, arthritis, toothaches, the common cold, or nasal congestion.

Interestingly, the products sold as Excedrin Migraine, Excedrin Menstrual and Excedrin Tension Headache contain identical active ingredients even though advertised for different conditions!

Excedrin ingredients

The active ingredients in Excedrin are Acetaminophen + Aspirin + Caffeine.

Acetaminophen

Acetaminophen (paracetamol) is a common painkiller used to treat aches and pain. It can also be used to reduce fever (100.4 °F [38 °C] and above).

Acetaminophen (paracetamol) is used to relieve mild to moderate pain from headaches, muscle aches, menstrual periods, colds and sore throats, toothaches, backaches, and reactions to vaccinations (shots), and to reduce fever. Acetaminophen may also be used to relieve the pain of osteoarthritis (arthritis caused by the breakdown of the lining of the joints). Acetaminophen is in a class of medications called analgesics (pain relievers) and antipyretics (fever reducers). It works by changing the way the body senses pain and by cooling the body.

Acetaminophen (paracetamol) is also available combined with other painkillers and anti-sickness medicines. It’s an ingredient in a wide range of cold and flu remedies.

Key facts on Acetaminophen

• Acetaminophen (paracetamol) takes up to an hour to work.
• The usual dose of Acetaminophen (paracetamol) is one or two 500mg tablets at a time.
• Don’t take Acetaminophen (paracetamol) with other medicines containing Acetaminophen (paracetamol).

Who can and can’t take Acetaminophen

Most people can take Acetaminophen (paracetamol) safely, including pregnant and breastfeeding women.

However, some people need to take extra care with Acetaminophen (paracetamol).

Check with your doctor or pharmacist if you:

• have had an allergic reaction to Acetaminophen (paracetamol) or any other medicines in the past
• have liver or kidney problems
• regularly drink more than the maximum recommended amount of alcohol (14 units a week)
• take medicine for epilepsy
• take medicine for tuberculosis (TB)
• take the blood-thinner warfarin and you may need to take Acetaminophen (paracetamol) on a regular basis

Before taking acetaminophen

• tell your doctor and pharmacist if you are allergic to acetaminophen, any other medications, or any of the ingredients in the product. Ask your pharmacist or check the label on the package for a list of ingredients.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, or herbal products you are taking or plan to take. Be sure to mention anticoagulants (‘blood thinners’) such as warfarin (Coumadin); isoniazid (INH); certain medications for seizures including carbamazepine (Tegretol), phenobarbital, and phenytoin (Dilantin); medications for pain, fever, coughs, and colds; and phenothiazines (medications for mental illness and nausea). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have ever developed a rash after taking acetaminophen.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking acetaminophen, call your doctor.
• if you drink three or more alcoholic beverages every day, do not take acetaminophen. Ask your doctor or pharmacist about the safe use of alcoholic beverages while taking acetaminophen.
• you should know that combination acetaminophen products for cough and colds that contain nasal decongestants, antihistamines, cough suppressants, and expectorants should not be used in children younger than 2 years of age. Use of these medications in young children can cause serious and life-threatening effects or death. In children 2 through 11 years of age, combination cough and cold products should be used carefully and only according to the directions on the label.
• if you have phenylketonuria (PKU, an inherited condition in which a special diet must be followed to prevent mental retardation), you should know that some brands of acetaminophen chewable tablets may be sweetened with aspartame, a source of phenylalanine.

Side effects of Acetaminophen

Acetaminophen (paracetamol) very rarely causes side effects if you take it at the right dosage.

If you’re worried about a side effect or notice anything unusual, talk to your pharmacist or doctor.

Serious allergic reaction

In rare cases, it’s possible to have a serious allergic reaction to Acetaminophen (paracetamol).

If you experience any of the following symptoms, stop taking acetaminophen and call your doctor immediately or get emergency medical attention:

• red, peeling or blistering skin
• rash
• hives
• itching
• swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
• hoarseness
• difficulty breathing or swallowing

Acetaminophen may cause other side effects. Call your doctor if you have any unusual problems while you are taking this medication.

Cautions with other medicines

It’s safe to take Acetaminophen (paracetamol) with most prescription medicines, including antibiotics.

Acetaminophen (paracetamol) isn’t suitable for some people. Talk to your doctor if you take:

• the blood-thinner warfarin (Acetaminophen (paracetamol) can increase the risk of bleeding if you take it regularly)
• medicine to treat epilepsy
• medicine to treat tuberculosis (TB)

Mixing Acetaminophen (paracetamol) with herbal remedies and supplements

Check with your doctor or pharmacist if you’re taking the herbal medicine St John’s wort for depression as you may need to reduce your Acetaminophen (paracetamol) dose.

Otherwise, Acetaminophen (paracetamol) isn’t generally affected by also taking herbal remedies or supplements.

Acetaminophen Overdose

An overdose of acetaminophen can damage your liver or cause death. If someone takes more than the recommended dose of acetaminophen, get medical help immediately, even if the person does not have any symptoms.

The first signs of an acetaminophen overdose include loss of appetite, nausea, vomiting, stomach pain, sweating, and confusion or weakness. Later symptoms may include pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes.

Symptoms of acetaminophen overdose may include the following:

• nausea
• vomiting
• loss of appetite
• sweating
• extreme tiredness
• unusual bleeding or bruising
• pain in the upper right part of the stomach
• yellowing of the skin or eyes (jaundice)
• flu-like symptoms

Aspirin

Aspirin is also known as acetylsalicylic acid in a class of drug called nonsteroidal anti-inflammatory drugs (NSAIDs) that is similar to non-steroidal inflammatory (NSAIDs) like Ibuprofen (Motrin or Advil) and naproxen (Aleve). Aspirin works by reducing substances in your body that cause pain, fever, and inflammation.

Aspirin can prevent the formation of blood clots which can make it useful in treating or preventing some conditions like heart attacks and strokes. The dosage for aspirin can range from 50 to 6000 milligrams (mg) per day depending on the condition being treated, and aspirin may be used in combination with other medications.

Aspirin is used to treat pain, and reduce fever or inflammation. It is sometimes used to treat or prevent heart attacks, strokes, and chest pain (angina).

Aspirin is a common medicine that has a number of uses, from relieving pain to reducing the risk of serious problems such as heart attacks and strokes.

Aspirin may be harmful to an unborn baby’s heart, and may also reduce birth weight or have other dangerous effects. Tell your doctor if you are pregnant or plan to become pregnant while you are taking Excedrin.

Aspirin can be used to treat:

• Mild to moderate pain
• Fever
• Swollen, red and tender body tissues
• Rheumatoid arthritis
• Rheumatic fever ¹

It is also used in the prevention of blood clots, heart attacks, strokes and bowel cancer ¹.

Aspirin should be used for cardiovascular conditions only under the supervision of a doctor.

Uses for aspirin

At high doses – usually 300mg – aspirin can relieve pain, reduce a high temperature (fever) and reduce swelling.

Aspirin is often used for short-term relief from:

• headaches and migraines
• toothache
• period pains
• general aches and pains
• colds and flu

Long-term treatment with low doses of aspirin – usually 75mg – has an antiplatelet effect, which means it makes the blood less sticky and can stop blood clots developing.

A doctor may recommend low doses of aspirin (75mg) if you have or have had:

• a heart attack or angina
• a stroke or transient ischemic attack (TIA)
• peripheral arterial disease
• coronary artery bypass surgery or another operation on your heart or blood vessels

Aspirin may also be prescribed for children after heart surgery or to treat Kawasaki disease. But it shouldn’t be given to anyone under 16 years old without medical supervision.

Who can and can’t take Aspirin

Most people can take aspirin safely. But you should get advice from a pharmacist or doctor before taking it if you:

• have had an allergic reaction to aspirin or non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, in the past
• have asthma
• have had stomach ulcers in the past
• have severe liver or kidney problems
• have hemophilia or another bleeding disorder
• have uncontrolled high blood pressure
• are looking for medication for a child under 16 – medication containing aspirin shouldn’t be given to children under 16
• are over 65 years of age
• are pregnant, breastfeeding or trying to get pregnant
• are taking other medications

You may still be able to take aspirin in these cases, but you should only do so if advised that it’s safe by a healthcare professional.

If you can’t take aspirin, a different medicine, such as paracetamol (for pain) or clopidogrel (to prevent blood clots), may be recommended instead.

Before taking aspirin

• tell your doctor and pharmacist if you are allergic to aspirin, other medications for pain or fever, tartrazine dye, or any other medications.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: acetazolamide (Diamox); angiotensin-converting enzyme (ACE) inhibitors such as benazepril (Lotensin), captopril (Capoten), enalapril (Vasotec), fosinopril (Monopril), lisinopril (Prinivil, Zestril), moexipril (Univasc), perindopril, (Aceon), quinapril (Accupril), ramipril (Altace), and trandolapril (Mavik); anticoagulants (‘blood thinners’) such as warfarin (Coumadin) and heparin; beta blockers such as atenolol (Tenormin), labetalol (Normodyne), metoprolol (Lopressor, Toprol XL), nadolol (Corgard), and propranolol (Inderal); diuretics (‘water pills’); medications for diabetes or arthritis; medications for gout such as probenecid and sulfinpyrazone (Anturane); methotrexate (Trexall); other nonsteroidal anti-inflammatory drugs (NSAIDs) such as naproxen (Aleve, Naprosyn); phenytoin (Dilantin); and valproic acid (Depakene, Depakote). Your doctor may need to change the doses of your medications or monitor you more carefully for side effects.
• if you are taking aspirin on a regular basis to prevent heart attack or stroke, do not take ibuprofen (Advil, Motrin) to treat pain or fever without talking to your doctor. Your doctor will probably tell you to allow some time to pass between taking your daily dose of aspirin and taking a dose of ibuprofen.
  tell your doctor if you have or have ever had asthma, frequent stuffed or runny nose, or nasal polyps (growths on the linings of the nose). If you have these conditions, there is a risk that you will have an allergic reaction to aspirin. Your doctor may tell you that you should not take aspirin.
• tell your doctor if you often have heartburn, upset stomach, or stomach pain and if you have or have ever had ulcers, anemia, bleeding problems such as hemophilia, or kidney or liver disease.
• tell your doctor if you are pregnant, especially if you are in the last few months of your pregnancy, you plan to become pregnant, or you are breast-feeding. If you become pregnant while taking aspirin, call your doctor. Aspirin may harm the fetus and cause problems with delivery if it is taken during the last few months of pregnancy.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking aspirin.
• if you drink three or more alcoholic drinks every day, ask your doctor if you should take aspirin or other medications for pain and fever.

How to take aspirin

Your pharmacist or doctor can tell you how often to take your aspirin and how much you should take. You can also check the recommendations in the leaflet that comes with your medicine.

Generally speaking:

• high-dose aspirin (to relieve pain) can be taken three or four times a day, with at least four hours between each dose, until your symptoms improve
• low-dose aspirin (to prevent blood clots) is taken once a day, usually for the rest of your life

Some medicine leaflets advise taking aspirin with water, while others may recommend taking it before or after food.

Follow the instructions in the leaflet or label that comes with your medicine. Ask your pharmacist if you’re not sure.

Aspirin interactions with other medicines, food and alcohol

Aspirin can potentially interact with other medications, including some complementary and herbal medicines, which could alter their effects or increase your risk of side effects.

Medicines that can interact with aspirin include:

• NSAIDs – such as ibuprofen or naproxen
• steroid medication – such as prednisolone
• anticoagulant medicines – such as warfarin or heparin
• SSRI antidepressants – such as citalopram, fluoxetine or paroxetine
• some medications used to treat high blood pressure – such as ACE inhibitors or diuretics
• some medicines used to treat epilepsy – such as phenytoin
• other medicines containing aspirin – including cold and flu remedies where aspirin is one of the ingredients

Taking aspirin with warfarin (anticoagulant medicine or blood thinner) or some blood pressure medicines may increase the risk of bleeding.

This is not a complete list. If you want to check whether a medicine is safe to take with aspirin, ask your doctor or pharmacist, or read the leaflet that comes with the medicine.

There are no known interactions between aspirin and food.

The risk of bleeding in the stomach may be higher if you drink alcohol while taking aspirin, so you may want to consider reducing how much you drink or avoiding alcohol completely.

Side effects of aspirin

Like all medications, there’s a risk of side effects from aspirin.

The most common side effects are:

• Indigestion and stomach aches – taking your medicine with food may help reduce this risk
• Bleeding or bruising more easily than normal

Other side effects of aspirin:

• Dizziness, ringing in the ears, blurred vision
• Drowsiness, fatigue, depression
• Thirst, sweating, fluid retention, swollen ankles
• Abdominal discomfort or bloating
• Nausea, heartburn, diarrhea, constipation

Uncommon and rare side effects include:

• hives – a raised, itchy rash
• tinnitus – hearing sounds that come from inside your body
• breathing difficulties or an asthma attack
• an allergic reaction – this can cause breathing problems, swelling of the mouth, lips or throat, and a sudden rash
• bleeding in the stomach – this can cause dark, tar-like stools or vomiting blood
• bleeding in the brain – this can cause a sudden, severe headache, vision problems and stroke symptoms, such as slurred speech and weakness on one side of the body

Long-term effects of taking aspirin:

Regular use of aspirin may eventually cause the following effects. It’s best to discuss the side effects of long term use with a medical practitioner.

• Anemia (low red blood cell count)
• Easy bruising and abnormal bleeding
• Inflamed stomach lining, stomach bleeding and peptic ulcers
• Vomiting blood that may look like coffee grounds and bowel motions that look like black tar
• An allergic-type reaction, wheezy breathing and a tightness in the chest in adults, hives in children, and in some rare cases swelling of the face, lips, tongue or around the eyes
• Reduced kidney and liver function

Speak to your doctor if you experience any concerning or troublesome side effects while taking aspirin.

Call your emergency number for an ambulance or go to your nearest accident and emergency (A&E) department if you think you’re having a severe allergic reaction, or you have symptoms of bleeding in your stomach or brain.

Aspirin Overdose

If the dose is too high, you might overdose. If you have any of these symptoms, call an ambulance straight away by dialing your local emergency number.

• Headaches
• Confusion
• Fever
• Deafness
• Vomiting
• Rapid and shallow breathing
• Seizures
• Stop breathing, coma and death
• Burning pain in the throat or stomach
• Decreased urination
• Restlessness
• Irritability
• Talking a lot and saying things that do not make sense
• Fear or nervousness
• Dizziness
• Double vision
• Uncontrollable shaking of a part of the body
• Abnormally excited mood
• Hallucination (seeing things or hearing voices that are not there)
• Drowsiness
• Loss of consciousness for a period of time

Caffeine

Caffeine is a stimulant drug, which means it speeds up the messages traveling between the brain and your body.

It’s found in the seeds, nuts and leaves of a number of different plants, including:

• Coffea Arabica (used for coffee)
• Camelia sinensis (used for tea)
• Cola acuminate (used as a nut, tea or in soft drinks including cola)
• Theobroma cacao (used in cocoa and chocolate)
• Paulinia cupana (used as guarana in snack bars and energy drinks)

Caffeine is used in a number of different products. The amount of caffeine in these products can vary dramatically, so it’s always best to check the label. The average amounts are listed below.

• 2 tablets of Excedrin = 130mg caffeine

The table below shows the amount of caffeine in common food and drinks. The caffeine amounts are averages, so they may change depending on the brand or how the food or drink is made. Check the package label on food and drinks to know how much caffeine they contain.

The amount of caffeine in foods and drinks varies a lot. For coffee and tea, the amount of caffeine depends on:

• The brand
• How it’s prepared
• The type of beans or leaves used
• The way it’s served (for example, as espresso or latte)
• The size of the cup. Not all coffee cups are the same size, even though you think of them as a cup. Check to see how many ounces your cup has, especially if you’re buying a cup of coffee or tea. If you’re making coffee or tea at home, measure to check the size of the cup.

Table 1. The amount of Caffeine used in a number of different products (approximates only)

Product	Average caffeine content (mg/100 ml)
Red Bull®	32.0
Mountain Dew®	15.0
Coca Cola®	9.7*
Diet Coke®	9.7*
Coke Zero®	9.6*
Brewed black tea	22.5
Brewed green tea	12.1
Coffee, cappuccino	101.9
Coffee, flat white	86.9
Coffee, long black	74.7
Coffee, from ground coffee beans, espresso style	194.0
Chocolate, milk with added milk solids	20.0
Chocolate, dark, high cocoa solids	59.0

[Source ²]

Some energy drinks contain large amounts of caffeine. For example, a 24-ounce energy drink may have up to 500 milligrams of caffeine. Energy drinks may have a lot of sugar, too, and they may contain ingredients that may be harmful to your baby during pregnancy. Because we don’t know a lot about all the ingredients in energy drinks, it’s best not to have them when you’re pregnant.

The amount of caffeine you get from food and drinks throughout the day adds up. So if you have a cup of coffee in the morning, you may want to limit or give up having other food and drinks during the day that have caffeine.

Effects of caffeine

Caffeine’s main effect is making people feel more awake for a short time. Caffeine aids the release of acid in the stomach, which can result in an upset stomach. Caffeine also helps get rid of fluids from the body (a diuretic).

There is no safe level of drug use. Use of any drug always carries some risk. It’s important to be careful when taking any type of drug.

Caffeine affects everyone differently, based on:

• Size, weight and health
• Whether the person is used to taking it
• Whether other drugs are taken around the same time
• The amount taken

The following effects may be experienced between 5 to 30 minutes after consuming caffeine, and may continue for up to 12 hours:

• Feeling more alert and active
• Restlessness, excitability and dizziness
• Anxiety and irritability
• Dehydration and needing to urinate more often
• Higher body temperature
• Faster breathing and heart rate
• Headache and lack of concentration
• Stomach pains ³

Children and young people who consume energy drinks containing caffeine may also suffer from sleep problems, bed-wetting and anxiety ⁴.

I am trying to become pregnant. Is it true that drinking caffeinated beverages will lower my chance to become pregnant?

Results from studies have been mixed. Some studies have suggested that high levels of caffeine (more than 300mg/day) might make it harder to conceive, but these findings are not proven. Low (less than 200mg/day) to moderate (about 200-300mg/day) caffeine consumption probably does not make it harder for a woman to get pregnant.

How does caffeine affect you and your baby during pregnancy?

Caffeine slightly increases your blood pressure and heart rate and the amount of urine your body makes. Caffeine may cause you to feel jittery, have indigestion or have trouble sleeping. During pregnancy, you may be especially sensitive to caffeine because it may take you longer to clear it from your body than if you weren’t pregnant.

When you have caffeine during pregnancy, it passes through the placenta to your baby. The placenta grows in your uterus (womb) and supplies the baby with food and oxygen through the umbilical cord.

You may have heard that too much caffeine can cause miscarriage (when a baby dies in the womb before 20 weeks of pregnancy). Some studies say this is true, and others don’t. Until scientists know more about how caffeine can affect pregnancy, it’s best to limit the amount you get to 200 milligrams each day. This is about the amount in 2 x 8-ounce cups of coffee or one 12-ounce cup of coffee. Be sure to check the size of your cup to know how much caffeine you’re getting.

Can caffeine cause or make it more likely to have a miscarriage?

There are many studies that have looked at this question. To date, researchers have not reported an association between low levels of caffeine and an increased risk for miscarriage. Most studies on moderate use of caffeine have not found an increased risk of miscarriage. Some studies suggest that taking very high levels (over 800 mg per day) or taking it in high doses with cigarettes or alcohol (both of which are known to increase the risk of miscarriage) may increase the risk for miscarriage.

Will drinking caffeinated beverages during my pregnancy cause birth defects in my baby?

No. Large amounts of caffeine have not been shown to cause an increased chance for birth defects.

Large amounts of caffeine could affect babies in the same way as it does adults. Some reports suggest that children born to mothers who consumed more than 500mg/day were more likely to have faster heart rates, shaking, increased breathing rate, and spend more time awake in the days following birth.

Does drinking caffeinated beverages in pregnancy cause long-term problems in behavior or learning for the baby?

Most studies find no effect on learning or behavior in young school aged children whose mothers consumed caffeine during pregnancy.

Can I drink caffeinated beverages while I breastfeed?

Caffeine passes into breast milk and it suggested that you limit how much you have. If you’re breastfeeding, limit caffeine to no more than two cups of coffee a day. The infant should also be watched for irritability and trouble with sleeping. It’s important to keep drinking water while breastfeeding. Be sure to talk to your health care provider about all your options for breastfeeding.

Is it a problem if the baby’s father consumes a lot of caffeine?

Studies on caffeine and male fertility or sperm quality have not reported consistent findings. In general, exposures that fathers have are unlikely to increase risks to a pregnancy.

Coming down

Some people consume drinks with caffeine so that they can continue working or studying at night. However, the after-effect is that they will feel tired and lethargic the next day.

Long-term effects of taking caffeine

Regular, heavy use of caffeine (such as more than 4 cups of coffee a day) may eventually cause:

• Osteoporosis
• High blood pressure and heart disease
• Heartburn
• Ulcers
• Difficulty sleeping
• Infertility (in men and women)
• Anxiety
• Depression
• Needing to use more to get the same effect
• Dependence on caffeine ⁵

Caffeine Withdrawal

Giving up caffeine after using it for a long time is challenging because the body has to get used to functioning without it. Withdrawal symptoms usually start within 24 hours after the last dose – or even within 6 hours for people who consume a lot of caffeine regularly. The symptoms can last for around 36 hours, or even longer for people who consume a lot.

These symptoms can include:

• Headache
• Tiredness
• Sweating
• Muscle pains
• Anxiety and tension ⁶

Caffeine Overdose

If a large amount of caffeine is consumed it could also cause an overdose. If you experience any of the following effects, call an ambulance straight away by dialing your local emergency number.

• Tremors
• Nausea and vomiting
• Very fast and irregular heart rate
• Confusion and panic attack
• Seizures ⁷

It’s possible to die from having too much caffeine, but this is extremely rare. This would usually only happen if 5–10g of caffeine (or 80 cups of strong coffee) were consumed one after the other ⁵.

In small children, caffeine poisoning can happen if a lower amount, such as around 1g of caffeine (equal to around 12 energy drinks) is consumed one after the other ⁸.

How much caffeine in Excedrin

• Excedrin Migraine: Acetaminophen 250mg + Caffeine 65 mg + Aspirin 250mg
• Excedrin Tension Headache: Acetaminophen 500mg + Caffeine 65 mg
• Excedrin Extra Strength: Acetaminophen 250 mg + Caffeine 65 mg + Aspirin 250 mg

In comparison a typical 8 ounce (236 ml) serving of brewed coffee contains at least 95-100mg of caffeine.

If you’re pregnant, limit the amount of caffeine you have to 200 milligrams (mg) a day. This is about the same as 2 x 8 ounce (236 ml) of instant coffee.

High levels of caffeine in pregnancy can result in babies having a low birthweight, which can increase the risk of health problems in later life. Too much caffeine can also cause a miscarriage.

Excedrin Important Information

Do not give Excedrin to a child or teenager with a fever, flu symptoms, or chicken pox. Aspirin can cause Reye’s syndrome, a serious and sometimes fatal condition in children.

Do not take more Excedrin than is recommended. An overdose of acetaminophen can damage your liver or cause death. Call your doctor at once if you have nausea, pain in your upper stomach, itching, loss of appetite, dark urine, clay-colored stools, or jaundice (yellowing of your skin or eyes).

Aspirin may cause stomach or intestinal bleeding, which can be fatal. Call your doctor at once if you have symptoms such as bloody or tarry stools, or coughing up blood or vomit that looks like coffee grounds.

In rare cases, acetaminophen may cause a severe skin reaction. Stop taking Excedrin and call your doctor right away if you have skin redness or a rash that spreads and causes blistering and peeling.

Excedrin Pregnancy Warnings

Two cases of acetaminophen overdose in late pregnancy have been reported. In both cases neither the neonate nor the mother suffered hepatic toxicity ⁹.

Investigations have revealed conflicting results with regards to the pharmacokinetic disposition of acetaminophen in pregnant women ¹⁰, ¹¹. One study has suggested that the oral clearance of acetaminophen is 58% higher and the elimination half-life is 28% longer in pregnant women compared to nonpregnant women ¹⁰. Another study has suggested that the elimination half-life is not different in patients who are pregnant. That study also suggested that the volume of distribution of acetaminophen may be higher in pregnant women ¹².

One study has suggested that acetaminophen in typical oral doses may result in a reduced production of prostacyclin in pregnant women ¹³. That study also suggested that acetaminophen does not affect thromboxane production.

The frequency of fetal exposure to aspirin reported in many studies may be underestimated because aspirin (and other salicylates) occur in many over-the-counter preparations and women may fail to recall taking aspirin and over-the-counter drugs ¹⁴.

Increased maternal bleeding can occur during delivery when aspirin is used 1 week prior to and/or during labor and delivery ¹⁵, ¹⁶, ¹⁷. Prolonged gestation and labor have been reported due to aspirin’s inhibition of prostaglandin.

A study ¹⁸ of the use of low-dose aspirin (60 mg per day) to prevent and treat preeclampsia in 9364 pregnant women (the Collaborative Low-dose Aspirin Study in Pregnancy–CLASP) did “not support routine prophylactic or therapeutic administration of antiplatelet therapy in pregnancy to all women at increased risk of preeclampsia or IUGR.” In that study, no excess of intraventricular hemorrhage, neonatal bleeds, or mortality attributable to bleeding were observed. The investigators did identify a possible role for low-dose aspirin in the treatment of early-onset preeclampsia severe enough to need very preterm delivery.

Another study ¹⁹ of low-dose aspirin (follow-up from the Italian Study of Aspirin in Pregnancy) has suggested that “low dose aspirin in pregnancy is safe with respect to the risks of malformation and of major impairment in development at 18 months of age.”

High-dose aspirin (2 g per day) has been associated with stillbirths, cerebral hemorrhage, oculoauriculovertebral dysplasia, neonatal salicylate toxicity, constricted ductus arteriosus, cyclopia, and neonatal acidosis. Some cases of congenital heart defects have been reported ¹⁹, ¹⁵. However, a case control study of aspirin use in the first trimester concluded that aspirin “does not increase the risk of congenital heart defects in relation to that of other structural malformations”.

In a study of 2817 fertile women, no evidence of adverse effects from caffeine was found. The fecundability ratio (adjusted for known risk factors for time to conceive) was 1.03 between fertile women who consumed more than 7000 mg caffeine per month and those who consumed 500 mg or less per month. Furthermore, caffeine was not associated with infertility in 1818 infertile women and their primiparous controls. In another study (n=441) no evidence was found that moderate caffeine use increased the risk of spontaneous abortion, intrauterine growth retardation, or microcephaly.

Aspirin has been assigned to pregnancy category C by the FDA. However, aspirin is considered to be in pregnancy category D by the FDA if full dose aspirin is taken in the third trimester. Use of nonsteroidal anti-inflammatory drugs during the third trimester of pregnancy should be avoided due to effects on the fetal cardiovascular system (closure of the ductus arteriosus). Aspirin use in pregnancy has been associated with alterations in both maternal and fetal hemostasis. In addition, high doses have been associated with increased perinatal mortality, intrauterine growth retardation, and teratogenic effects.

Acetaminophen has not been formally assigned to pregnancy category by the FDA. It is routinely used for short-term pain relief and fever in all stages of pregnancy. Acetaminophen is believed to be safe in pregnancy when used intermittently for short durations.

Caffeine has been assigned to pregnancy category B by the FDA. Both human and animal studies have failed to reveal evidence of significant mutagenic or carcinogenic effects. Caffeine crosses the placenta. Fetal blood and tissue levels in the fetus are similar to those in the mother. Caffeine has been reported to be an animal teratogen only with doses high enough to cause toxicity in the mother. In 1980, the Food and Drug Administration issued an advisory (based primarily on animal evidence) which stated that pregnant women should limit there intake of caffeine to a minimum. During the first two trimesters of pregnancy, the combination of acetaminophen, aspirin, and caffeine should only be given during pregnancy when clearly needed and when benefit outweighs risk. Because of the aspirin component of this combination drug, during the last trimester of pregnancy, this combination product is only recommended for use when there are no alternatives and benefits outweigh risk.

Excedrin Breastfeeding Warnings

One small study has reported that following a 1000 mg dose of acetaminophen to nursing mothers, nursing infants receive less than 1.85% of the weight-adjusted maternal oral dose ²⁰.

Aspirin is excreted into human milk in small amounts ²¹, ²². Peak milk salicylate levels have been reported at nine hours after maternal dosing (and measured at 1.1 mg/dL). Use of large doses of aspirin can result in rashes, platelet abnormalities, and bleeding in nursing infants. Because of a single case report of metabolic acidosis, the American Academy of Pediatrics ²³ characterizes aspirin as a drug that has been “associated with significant effects on some nursing infants and should be given to nursing mothers with caution.”

Acetaminophen is excreted into human milk in small concentrations ²¹. One case of a rash has been reported in a nursing infant. Acetaminophen is considered compatible with breast-feeding by the American Academy of Pediatrics.

Caffeine is excreted into human milk in small amounts ²⁴. Adverse effects in the nursing infant are unlikely. However, irritability and poor sleep patterns have been reported in nursing infants. The amount of caffeine generally found in caffeinated beverages is considered to usually be compatible with breast-feeding by the American Academy of Pediatrics. Because caffeine is excreted into human milk and because caffeine is metabolized slowly by nursing infants, consumption of more than moderate levels of caffeine by nursing mothers is not recommended.

Before taking Excedrin

Do not give Excedrin to a child or teenager with a fever, flu symptoms, or chicken pox. Aspirin can cause Reye’s syndrome, a serious and sometimes fatal condition in children.

You should not use Excedrin if you are allergic to acetaminophen (Tylenol), aspirin, caffeine, or any NSAIDs (Advil, Motrin, Aleve, Orudis, Indocin, Lodine, Voltaren, Toradol, Mobic, Relafen, Feldene, and others).

Aspirin may cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are taking Excedrin.

Ask a doctor or pharmacist if it is safe for you to take Excedrin if you have other medical conditions, especially:

• liver disease, cirrhosis, a history of alcoholism, or if you drink more than 3 alcoholic beverages per day;
• asthma or seasonal allergies;
• fever with a stiff neck;
• stomach ulcer, stomach or intestinal bleeding, ulcerative colitis;
• a bleeding or blood clotting disorder such as hemophilia;
• kidney disease; or
• if you use medicine to treat glaucoma or prevent blood clots.

If you take Excedrin to treat headache pain, seek medical attention if you have:

• a headache so bad you have to lie down;
• a headache that causes vomiting;
• what feels like the worst headache you’ve ever had;
• a headache that seems different from your usual headaches;
• a headache every day;
• a headache after coughing, bending, exercising, or head injury;
• if you have never had migraines diagnosed by a doctor; or
• if you are having your first headache after age 50.

Aspirin may be harmful to an unborn baby’s heart, and may also reduce birth weight or have other dangerous effects. Tell your doctor if you are pregnant or plan to become pregnant while you are taking Excedrin.

Aspirin, acetaminophen, and caffeine can pass into breast milk and may harm a nursing baby. You should not breast-feed while using Excedrin.

How should I take Excedrin?

Use Excedrin exactly as directed on the label, or as it has been prescribed by your doctor. Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death.

Take Excedrin with food or milk if it makes your stomach upset.

Call your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever lasting longer than 3 days, or any swelling or pain lasting longer than 10 days.

This medication can cause unusual results with certain lab tests for glucose (sugar) in the urine. Tell any doctor who treats you that you are using Excedrin.

If you need surgery, tell the surgeon ahead of time that you are using Excedrin. You may need to stop using the medicine for a short time.

Store Excedrin at room temperature away from moisture and heat.

What should I avoid?

Avoid drinking alcohol while you are taking Excedrin. Alcohol may increase your risk of stomach bleeding while taking aspirin, or liver damage while taking acetaminophen.

Ask a doctor or pharmacist before using any other cough, cold, allergy, pain, menstrual symptom, or fever medication. Acetaminophen (paracetamol) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose. Aspirin and caffeine are also contained in many combination medicines. Check the label to see if a medicine contains acetaminophen (paracetamol), aspirin, or caffeine.

Avoid taking another NSAID (nonsteroidal anti-inflammatory drug) such as aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others.

Avoid coffee, tea, cola, energy drinks or other sources of caffeine while taking Excedrin. They can add to the side effects of the caffeine in the medication.

What happens if I miss a dose?

Since Excedrin is used when needed, you may not be on a dosing schedule. If you are on a schedule, use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

Excedrin dosage

Excedrin (Acetaminophen + Aspirin + Caffeine) Dosage

• Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Usual Adult Dose for Analgesic/Antipyretic

Up to a total of 650 of acetaminophen and aspirin combined every 4-6 hours as needed.

Usual Adult Dose for Migraine

500 mg acetaminophen, 500 mg aspirin, and 130 mg of caffeine in combination per day as needed.

Maximum duration of migraine therapy: 48 hours

Renal Dose Adjustments

Detailed information concerning the pharmacokinetic disposition of aspirin in patients with renal dysfunction is not available. Aspirin should be used with caution in chronic renal insufficiency, since it may cause a transient decrease in renal function. The use of aspirin in patients with severe renal impairment (CrCl less than 10 mL/minute) is not recommended due to the potential for increased risk of salicylate toxicity.

Liver Dose Adjustments

Use acetaminophen with caution in patients with liver disease. Chronic use of acetaminophen is not recommended in patients with liver disease.

The use of aspirin in patients with severe hepatic impairment is not recommended due to the potential for increased risk of clinically significant bleeding and other adverse effects.

Kidney Dialysis

Detailed information concerning the removal of aspirin by hemodialysis is not available. Some investigators have suggested that aspirin and/or salicylate may be removed by hemodialysis and that aspirin dosing should follow dialysis sessions.

Excedrin Tension Headache

Active ingredients: Acetaminophen 500 mg + Caffeine 65 mg

Inactive Ingredients: Carnauba wax, D&C red #27 aluminum lake, FD&C yellow #6 aluminum lake, FD&C blue #2 aluminum lake, magnesium stearate acid, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, sodium starch glycolate, stearic acid, talc, titanium dioxide

Excedrin Tension Headache uses:

• Temporarily relieves minor aches and pains due to:
  • Headache
  • Muscular Aches

Excedrin Tension Headache Directions of Use:

• Do not use more than directed
• Adults and children 12 years and over: Take 2 caplets every 6 hours; not more than 6 caplets in 24 hours
• Children under 12 years: Ask a doctor

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Other information:

• store at room temperature 20°-25°C (68°-77°F)
• close cap tightly after use
• read all product information before using. Keep box for important information

Excedrin Tension Headache Warnings

Allergy alert

Acetaminophen may cause severe skin reactions.

Symptoms may include:

• skin reddening
• blisters
• rash

If a skin reaction occurs, stop use and seek medical help right away.

Ask a doctor before use if:

• you have liver disease
• you are pregnant or breastfeeding
• you are taking taking the blood thinning drug warfarin.

Liver warning

This product contains acetaminophen. Severe liver damage may occur if you take:

• more than 6 caplets in 24 hours, which is the maximum daily amount
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while using this product

Do NOT use

• if you are allergic to acetaminophen
• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist

Caffeine warning

The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heartbeat.

Stop use and ask a doctor if:

• any new symptoms occur
• painful area is red or swollen
• pain gets worse or lasts for more than 10 days
• fever gets worse or lasts for more than 3 days

These could be signs of a serious condition.

Excedrin Extra Strength

Active ingredients: Acetaminophen 250 mg + Caffeine 65 mg + Aspirin 250 mg [a Non-Steroidal Anti-Inflammatory Drug (NSAID)]

Inactive Ingredients: benzoic acid, carnauba wax, FD&C blue #1, hydroxypropylcellulose, hypromellose, light mineral oil, microcrystalline cellulose, polysorbate 20, povidone, propylene glycol, simethicone emulsion, sorbitan monolaurate, stearic acid, titanium dioxide

Excedrin Extra Strength uses:

• Temporarily relieves minor aches and pains due to:
  • Headache
  • A Cold
  • Arthritis
  • Muscular Aches
  • Toothache
  • Premenstrual and Menstrual Cramps

Excedrin Extra Strength Directions of Use:

• Do not use more than directed
• Drink a full glass of water with each dose
• Adults and children 12 years and over: Take 2 tablets every 6 hours; not more than 8 tablets in 24 hours
• Children under 12 years: Ask a doctor

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Other information:

• store at room temperature 20°-25°C (68°-77°F)
• close cap tightly after use
• read all product information before using. Keep box for important information

Excedrin Extra Strength Warnings

Reye’s syndrome

Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye’s syndrome, a rare but serious illness.

Allergy alert

Acetaminophen may cause severe skin reactions.

Symptoms may include:

• skin reddening
• blisters
• rash

If a skin reaction occurs, stop use and seek medical help right away.

Allergy alert

Aspirin may cause a severe allergic reaction which may include:

• hives
• facial swelling
• asthma (wheezing)
• shock

Ask a doctor or pharmacist before use if:

• you are pregnant or breastfeeding. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
• you are taking a prescription drug for diabetes, gout, or arthritis
• you are taking any other drug, or are under a doctor’s care for any serious condition

Ask a doctor before use if:

• you have liver disease
• stomach bleeding warning applies to you
• you have a history of stomach problems, such as heartburn
• you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
• you are taking a diuretic
• you have asthma

Liver warning

This product contains acetaminophen. Severe liver damage may occur if you take:

• more than 8 tablets in 24 hours, which is the maximum daily amount
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while using this product

Stomach bleeding warning

This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:

• are age 60 or older
• have had stomach ulcers or bleeding problems
• take a blood thinning (anticoagulant) or steroid drug
• take other drugs containing prescription or nonprescription NSAlDs (aspirin, ibuprofen, naproxen, or others)
• have 3 or more alcoholic drinks every day while using this product
• take more or for a longer time than directed

Do NOT use:

• if you have ever had an allergic reaction to acetaminophen, aspirin or any other pain reliever/fever reducer
• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Caffeine warning

The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heartbeat.

Stop use and ask a doctor if:

• an allergic reaction occurs. Seek medical help right away.
• you experience any of the following signs of stomach bleeding:
  • feel faint
  • vomit blood
  • have bloody or black stools
  • have stomach pain that does not get better
• ringing in the ears or loss of hearing occurs
• painful area is red or swollen
• pain gets worse or lasts for more than 10 days
• fever gets worse or lasts for more than 3 days
• any new symptoms occur

These could be signs of a serious condition.

Excedrin Migraine

Active ingredients: Acetaminophen 250 mg + Caffeine 65 mg + Aspirin 250 mg [a Non-Steroidal Anti-Inflammatory Drug (NSAID)]

Inactive Ingredients: benzoic acid, carnauba wax, FD&C blue #1, hydroxypropylcellulose, hypromellose, light mineral oil, microcrystalline cellulose, polysorbate 20, povidone, propylene glycol, simethicone emulsion, sorbitan monolaurate, stearic acid, titanium dioxide

Excedrin Migraine uses:

• Treats Migraines
  

Excedrin Migraine Directions of Use:

• Do not use more than directed. If symptoms persist or worsen, ask your doctor
• Drink a full glass of water with each dose
• Adults: Take 2 caplets with a glass of water. Do not take more than 2 caplets in 24 hours, unless directed by a doctor.
• Under 18 years of age: Ask a doctor

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Other information:

• store at at room temperature 20°-25°C (68°-77°F)
• close cap tightly after use
• read all product information before using. Keep box for important information

Excedrin Migraine Warnings

Reye’s syndrome

Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye’s syndrome, a rare but serious illness.

Allergy alert

Acetaminophen may cause severe skin reactions.

Symptoms may include:

• skin reddening
• blisters
• rash

If a skin reaction occurs, stop use and seek medical help right away.

Allergy alert

Aspirin may cause a severe allergic reaction which may include:

• hives
• facial swelling
• asthma (wheezing)
• shock

Ask a doctor or pharmacist before use if:

• you are pregnant or breastfeeding. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
• you are taking a prescription drug for diabetes, gout, or arthritis
• you are taking any other drug, or are under a doctor’s care for any serious condition
• taking any other product that contains aspirin, acetaminophen, or any other pain reliever/fever reducer

Ask a doctor before use if:

• you have never had migraines diagnosed by a health professional
• you have a headache that is different from your usual migraines
• you have the worst headache of your life
• you have fever and stiff neck
• you have headaches beginning after or caused by head injury, exertion, coughing or bending
• you experienced your first headache after the age of 50
• you have daily headaches
• you have a migraine so severe as to require bed rest
• you have liver disease
• stomach bleeding warning applies to you
• you have a history of stomach problems, such as heartburn
• you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
• you are taking a diuretic
• you have asthma
• you have problems or serious side effects from taking pain relievers or fever reducers
• you have vomiting with your migraine headache

Liver warning

This product contains acetaminophen. Severe liver damage may occur if you take:

• more than 2 caplets in 24 hours, which is the maximum daily amount
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while using this product

Stomach bleeding warning

This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:

• are age 60 or older
• have had stomach ulcers or bleeding problems
• take a blood thinning (anticoagulant) or steroid drug
• take other drugs containing prescription or nonprescription NSAlDs (aspirin, ibuprofen, naproxen, or others)
• have 3 or more alcoholic drinks every day while using this product
• take more or for a longer time than directed

Do NOT use:

• if you have ever had an allergic reaction to acetaminophen, aspirin or any other pain reliever/fever reducer
• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Caffeine warning

The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heartbeat.

Stop use and ask a doctor if:

• an allergic reaction occurs. Seek medical help right away.
• you experience any of the following signs of stomach bleeding:
  • feel faint
  • vomit blood
  • have bloody or black stools
  • have stomach pain that does not get better
• your migraine is not relieved or worsens after first dose
• ringing in the ears or loss of hearing occurs
• any new or unexpected symptoms occur

These could be signs of a serious condition.

Excedrin side effects

General

General side effects including caffeinism have been reported. Consumption of higher doses of caffeine (>600 mg/day) has been reported to have lead to caffeinism. Caffeinism is a syndrome characterized by anxiety, restlessness, and sleep disorders (similar to anxiety states). It has also been reported that chronic, heavy caffeine ingestion may be associated with depression. Caffeine may cause anxiety and panic in panic disorder patients and may aggravate premenstrual syndrome (PMS).

In general, many side effects noted with aspirin use are dose-related.

Common Excedrin side effects may include:

• upset stomach, heartburn;
• depressed mood, feeling anxious or restless; or
• sleep problems (insomnia).

Excedrin serious side effects

Get emergency medical help if you have any of these signs of an allergic reaction to Excedrin: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

In rare cases, acetaminophen may cause a severe skin reaction that can be fatal. This could occur even if you have taken acetaminophen in the past and had no reaction. Stop taking Excedrin and call your doctor right away if you have skin redness or a rash that spreads and causes blistering and peeling. If you have this type of reaction, you should never again take any medicine that contains acetaminophen.

Stop using Excedrin and call your doctor at once if you have:

• severe anxiety, agitation, confusion, panic;
• easy bruising or bleeding;
• a light-headed feeling, like you might pass out;
• if you feel very thirsty or hot, are unable to urinate, and have heavy sweating or hot and dry skin;
• symptoms of stomach bleeding–bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
• high potassium–slow heart rate, weak pulse, muscle weakness, tingly feeling; or
• liver problems–nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
• Signs of bleeding like throwing up blood or throw up that looks like coffee grounds; coughing up blood; blood in the urine; black, red, or tarry stools; bleeding from the gums; vaginal bleeding that is not normal; bruises without a reason or that get bigger; or any bleeding that is very bad or that you cannot stop.
• Feeling confused.
• Feeling very tired or weak.
• Very bad dizziness or passing out.
• Ringing in ears.
• Hearing loss.
• Very bad headache or if headache is not better after the first dose.
• A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.
• Very bad stomach ulcers or bleeding can happen with this drug. Taking it in high doses or for a long time, smoking, or drinking alcohol raises the chance of these side effects. Taking this drug with food will not lower the chance of these effects. Call your doctor or get medical help right away if you get very bad stomach or back pain; black, tarry, or bloody stools; throwing up blood or throw up that looks like coffee grounds; or weight gain or swelling that is not normal.

Other side effects of Exedrin

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Belly pain or heartburn.
• Upset stomach.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

Hepatic

Alcoholic patients may develop hepatotoxicity after even modest doses of acetaminophen. In healthy patients, approximately 15 grams of acetaminophen is necessary to deplete liver glutathione stores by 70% in a 70 kg person. However, hepatotoxicity has been reported following smaller doses. Glutathione concentrations may be repleted by the antidote N-acetylcysteine. One case report has suggested that hypothermia may also be beneficial in decreasing liver damage during overdose.

In a recent retrospective study of 306 patients admitted for acetaminophen overdose, 6.9% had severe liver injury but all recovered. None of the 306 patients died.

One study has suggested that acetaminophen may precipitate acute biliary pain and cholestasis. The mechanism of this effect may be related to inhibition of prostaglandin and alterations in the regulation of the sphincter of Oddi.

Cases of acute pancreatitis have been reported rarely with the use of acetaminophen.

A 19 year old female developed hepatotoxicity, reactive plasmacytosis and agranulocytosis followed by a leukemoid reaction after acute acetaminophen toxicity.

Hepatic side effects including hepatotoxicity and hepatitis have been reported.

In alcoholic patients, severe and sometimes fatal dose dependent hepatitis has been reported with acetaminophen use. Hepatotoxicity has been increased during fasting.

Cases of aspirin induced hepatotoxicity and cholestatic hepatitis, particularly at high doses, have been reported rarely.

Gastrointestinal

Endoscopically identifiable gastric mucosal lesions occur in most patients who receive a single dose of aspirin. Clinically evident gastrointestinal bleeding has been reported in as many as 3% of treated elderly patients. Anorectal ulceration and rectal stenosis have been reported in patients who abuse aspirin containing rectal suppositories. One case controlled study has suggested that an association between aspirin (and other NSAID) consumption and appendicitis may exist.

Gastrointestinal side effects have been common and have included epigastric distress (in as many as 83% of patients treated with regular aspirin), abdominal discomfort or pain, endoscopically identifiable gastric mucosal lesions, nausea, and vomiting. More serious gastrointestinal effects include hemorrhage, peptic ulcers, perforation, and esophageal ulcerations.

In clinical trials of caffeine citrate, five cases of necrotizing enterocolitis were reported among the 46 infants exposed to the caffeine citrate injection.

Gastrointestinal side effects have been rare with the use of acetaminophen, except in alcoholics and after overdose.

Renal

The mechanism of an aspirin induced decrease in renal function may be related to inhibition of renal prostaglandin synthesis with consequent decreases in renal blood flow. Vasodilating renal prostaglandins may be particularly important in patients who exhibit arterial underfilling (i.e. heart failure, cirrhosis). The administration of high doses of NSAIDs to such patients has produced acute renal failure in rare instances.

Acetaminophen: Acute tubular necrosis usually occurs in conjunction with liver failure, but has been observed as an isolated finding in rare cases. A possible increase in the risk of renal cell carcinoma has been associated with chronic acetaminophen use as well.

A case control study of patients with end stage renal disease suggested that long term consumption of acetaminophen may significantly increase the risk of end stage renal disease particularly in patients taking more than two pills per day.

Renal side effects of aspirin have included reduction in glomerular filtration rate (particularly in patients who are sodium restricted or who exhibit diminished effective arterial blood volume, such as patients with advanced heart failure or cirrhosis), interstitial nephritis, papillary necrosis, elevations in serum creatinine, elevations in blood urea nitrogen, proteinuria, hematuria, and renal failure.

Renal side effects have been rare with acetaminophen use and have included acute tubular necrosis and interstitial nephritis. Adverse renal effects are most often observed after overdose, after chronic abuse (often with multiple analgesics), or in association with acetaminophen related hepatotoxicity.

Hypersensitivity

Hypersensitivity side effects of aspirin have included bronchospasm, rhinitis, conjunctivitis, urticaria, angioedema, and anaphylaxis. Approximately 10% to 30% of asthmatics are aspirin sensitive (with the clinical triad of aspirin sensitivity, bronchial asthma, and nasal polyps).

Hypersensitivity reactions such as anaphylaxis and fixed drug eruptions have rarely been reported in association with acetaminophen use.

The mechanism of aspirin induced hypersensitivity may be related to an up-regulation of the 5-lipoxygenase pathway of arachidonic acid metabolism with a resulting increase in the products of 5-lipoxygenase (such as leukotrienes).

Hematologic

Hematologic side effects of aspirin (in addition to predictable antiplatelet effects which may result in hemorrhage) have included increased blood fibrinolytic activity. In addition, hypoprothrombinemia, thrombocytopenia, thrombocyturia, megaloblastic anemia, and pancytopenia have been reported rarely. Aplastic anemia has also been reported.

Rare cases of thrombocytopenia associated with acetaminophen have been reported. Methemoglobinemia with resulting cyanosis has also been observed in the setting of acute overdose.

Dermatologic

Dermatologic side effects from the use of aspirin including Stevens-Johnson syndrome and a lichenoid eruption have been reported rarely.

Dermatologic side effects associated with acetaminophen includes the risk of rare but potentially fatal serious skin reactions known as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis and acute generalized exanthematous pustulosis (AGEP). Erythematous skin rashes associated with acetaminophen have been reported, but are rare. Acetaminophen associated bullous erythema and purpura fulminans have been reported.

Respiratory

Respiratory side effects including hyperpnea, pulmonary edema, and tachypnea have occurred in patients receiving aspirin.

A case of acetaminophen induced eosinophilic pneumonia has been reported.

Cardiovascular

Two cases hypotension have been reported following the administration of acetaminophen. Both patients experienced significant decreases in blood pressure. One of the two patients required pressor agents to maintain adequate mean arterial pressures. Neither episode was associated with symptoms of anaphylaxis. Neither patient was rechallenged after resolution of the initial episode.

Cardiovascular side effects of aspirin have been reported rarely and have included salicylate induced variant angina, ventricular ectopy, conduction abnormalities, and hypotension, particularly during salicylate toxicity.

Several cases of hypotension have been reported following the administration of acetaminophen.

Metabolic

Metabolic side effects of aspirin have included dehydration and hyperkalemia. Respiratory alkalosis and metabolic acidosis, particularly during salicylate toxicity, have been reported. A case of hypoglycemia has also been reported in a patient on hemodialysis.

Nervous system

Nervous system side effects in patients receiving aspirin have included agitation, cerebral edema, coma, confusion, dizziness, headache, cranial hemorrhage, lethargy, and seizures. Some investigators have reported that modest doses may result in decreased frequency selectivity and may therefore impair hearing performance, particularly in the setting of background noise.

Regarding the use of aspirin, some investigators have suggested that tinnitus may be a less reliable indicator of salicylate toxicity than previously believed. Patients with high frequency hearing loss may have difficulty perceiving tinnitus. In a study of rheumatoid arthritis patients, those with tinnitus had no greater salicylate levels than those without tinnitus. Elderly patients may be less likely to perceive tinnitus than younger patients.

Musculoskeletal

Musculoskeletal side effects including rhabdomyolysis have occurred in patients receiving aspirin.

Endocrine

Endocrine side effects of aspirin use have included hypoglycemia and hyperglycemia.

Ocular

Ocular side effects including cases of localized periorbital edema have been reported rarely in patients receiving aspirin.

Oncologic

Oncologic side effects have been reported. Several epidemiologic studies have suggested that chronic aspirin use may decrease the risk of large bowel neoplasms. However, other studies have not found this beneficial effect.

Other side effects

Other side effect have also been reported. In one study of the effects of caffeine, 634 women with fibrocystic breast disease (compared to 1066 women without the disease), the occurrence of fibrocystic breast disease was positively associated with average daily consumption of caffeine. Women who consumed 31 to 250 mg/day of caffeine were reported to have a 1.5 times increase in odds to have the disease. Women who consumed over 500 mg/day of caffeine were reported to have a 2.3 times increase in odds.

Reye’s syndrome, although rare, has been associated with aspirin use in children with an acute viral illness. Reye’s syndrome has also been reported even more rarely in adults.

Prolonged labor and pregnancy, decreased infant birth weight and stillborn births, antepartum and postpartum bleeding have occurred due to aspirin use by women during the third trimester of pregnancy.

Reye’s syndrome typically involves vomiting, neurologic dysfunction, and hepatic dysfunction during or shortly after an acute viral infection.

Excedrin overdose

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. This is a free and confidential service. All local poison control centers in the United States use this national number. You should call if you have any questions about poisoning or poison prevention. It does NOT need to be an emergency. You can call for any reason, 24 hours a day, 7 days a week.

References

1. Upfal J. (2006) The Australian Drug Guide (7th Ed.) Melbourne: Black Inc.
2. Food Regulation Standing Committee, Caffeine Working Group. (2013). The regulation of caffeine in foods.
3. Upfal, J. (2006). The Australian drug guide. (7th ed.). Melbourne: Black Inc.
4. Seifer, S., Schaechter, J., Hershorin, E. & Lepshultz, S. (2011). Health effects of energy drinks on children, adolescents, and young adults. Pediatrics, 127(3). 511–528. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3065144/
5. Brands, B., Sproule, B., & Marshman, J. (Eds.). (1998). Drugs & drug abuse (3rd ed.). Ontario: Addiction Research Foundation.
6. American Psychiatric Association. (2013). Diagnostic and Statistical Manual of Mental Disorders. (5th ed). Washington: American Psychiatric Publishing.
7. NPS Medicinewise. (2013). https://www.nps.org.au/news#Information
8. Arria, A., Calderia, K., Kasperski, S., O’Grady, K., Vincent, K., Griffiths, R. & Wish, E. (2010). Increased alcohol consumption, nonmedical prescription drug use, and illicit drug use are associated with energy drink consumption among college students. Journal of Addiction Medicine, 4(2). 74–80. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2923814/
9. Byer AJ, Traylor TR, Semmer JR “Acetaminophen overdose in the third trimester of pregnancy.” JAMA 247 (1982): 3114-5
10. Rayburn W, Shukla U, Stetson P, Piehl E “Acetaminophen pharmacokinetics: comparison between pregnant and nonpregnant women.” Am J Obstet Gynecol 155 (1986): 1353-6
11. Galinsky RE, Levy G “Absorption and metabolism of acetaminophen shortly before parturition.” Drug Intell Clin Pharm 18 (1984): 977-9
12. Beaulac-Baillargeon L, Rocheleau S “Paracetamol pharmacokinetics during the first trimester of human pregnancy.” Eur J Clin Pharmacol 46 (1994): 451-4
13. O’Brien WF, Krammer J, O’Leary TD, Mastrogiannis DS “The effect of acetaminophen on prostacyclin production in pregnant women.” Am J Obstet Gynecol 168 (1993): 1164-9
14. Briggs GG, Freeman RK, Yaffe SJ.. “Drugs in Pregnancy and Lactation. 5th ed.” Baltimore, MD: Williams & Wilkins;1998
15. Rudolph AM “Effects of aspirin and acetaminophen in pregnancy and in the newborn.” Arch Intern Med 141 (1981): 358-63
16. Karlowicz MG, White LE “Severe intracranial hemorrhage in a term neonate associated with maternal acetylsalicylic acid ingestion.” Clin Pediatr (Phila) 32 (1993): 740-3
17. Schoenfeld A, Bar Y, Merlob P, Ovadia Y “NSAIDs: maternal and fetal considerations.” Am J Reprod Immunol 28 (1992): 141-7
18. “Clasp: a randomised trial lf low-dose aspirin for the prevention and treatment of pre-eclampsia among 9364 pregnant women.” Lancet 343 (1994): 619-29
19. Parazzini F, Bortolus R, Chatenoud L, Restelli S, Benedetto C “Follow-up of children in the italian study of aspirin in pregnancy.” Lancet 343 (1994): 1235
20. Committee on Drugs, 1992 to 1993 “The transfer of drugs and other chemicals into human milk.” Pediatrics 93 (1994): 137-50
21. Matheson I, Lunde PK, Notarianni L “Infant rash caused by paracetamol in breast milk.” Pediatrics 76 (1985): 651-2
22. Erickson SH, Oppenheim GL “Aspirin in breast milk.” J Fam Pract 8 (1979): 189-90
23. Roberts RJ, Blumer JL, Gorman RL, et al “American Academy of Pediatrics Committee on Drugs: Transfer of drugs and other chemicals into human milk.” Pediatrics 84 (1989): 924-36
24. Berlin CM Jr, Denson HM, Daniel CH, Ward RM “Disposition of dietary caffeine in milk, saliva, and plasma of lactating women.” Pediatrics 73 (1984): 59-63

What is Pepto Bismol

Pepto-Bismol is an antacid and anti-diarrhea medication. Pepto-Bismol is used to treat diarrhea in adults and children 12 years of age and older. Pepto-Bismol is also used to relieve the symptoms of an upset stomach, such as heartburn, indigestion, and nausea in adults and children 12 years of age and older. The active ingredient in Pepto-Bismol is bismuth subsalicylate.

Pepto-Bismol is available without a prescription. However, if you are taking Pepto Bismol (bismuth subsalicylate) medicine for diarrhea, check with your doctor:

• if your symptoms do not improve within 2 days or if they become worse.
• if you also have a high fever.

Pepto Bismol (bismuth subsalicylate) is available in the following dosage forms:

• Suspension
• Tablet
• Tablet, Chewable

How does Pepto Bismol work?

Pepto Bismol (bismuth subsalicylate) is in a class of medications called antidiarrheal agents. It works by decreasing the flow of fluids and electrolytes into the bowel, reduces inflammation within the intestine, and may kill the organisms that can cause diarrhea.

Why does Pepto-Bismol sometimes darken the tongue/stool and how long does it last?

This discoloration is temporary and harmless. The active ingredient in Pepto-Bismol contains bismuth. When a small amount of bismuth combines with trace amounts of sulfur in your saliva and gastrointestinal tract, a black-colored substance (bismuth sulfide) is formed. This discoloration is temporary and harmless. It can last several days after you stop taking Pepto-Bismol. Individual bowel habits, your age (the intestinal tract slows down with age), and the amount of the product taken all help to determine how long Pepto-Bismol is in your system.

Can I give Pepto-Bismol to my child?

Pepto-Bismol is indicated only for adults and children 12 years and over. Use only as directed.

For children 2 years and older, Children’s Pepto Antacid (contains Calcium Carbonate 400 mg in each Children’s Pepto Antacid chewable tablet) can be used to relieve heartburn, acid indigestion, sour stomach, and upset stomach due to these symptoms. Note the difference between Children’s Pepto Antacid that contains Calcium Carbonate unlike the actual Pepto-Bismol that contains Bismuth subsalicylate. Subsalicylate is chemically related to aspirin; therefore, includes similar warning statements to aspirin.

I have been giving Pepto-Bismol to my child when he/she had an upset stomach – should I be concerned?

Pepto-Bismol is indicated only for adults and children 12 years and over. Use only as directed.

Pepto Bismol contains both bismuth and subsalicylate. Subsalicylate is chemically related to aspirin; therefore, includes similar warning statements. Hepatic injury has been reported with chronic therapeutic use ¹. Salicylates have been linked with Reye’s syndrome in children. Hypoglycemia may develop, especially in children ¹.

The acute ingestion of less than 150 mg/kg or 6.5 g of aspirin equivalent, whichever is less, is not expected to cause significant toxicity.

In young children, the initial respiratory alkalosis from salicylate intoxication is transient, they often have a predominant metabolic acidosis (and in severe cases also respiratory alkalosis) on presentation.

What does the label say about Reye’s syndrome and Pepto-Bismol?

Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use Pepto-Bismol. When using this product, if changes in behavior with nausea or vomiting occur, consult a doctor because these symptoms could be an early sign of Reye’s syndrome, a rare but serious illness. Subsalicylate is chemically related to aspirin; therefore, includes similar warning statements.

How should Pepto Bismol be used?

Pepto Bismol (bismuth subsalicylate) comes as a liquid, tablet, or chewable tablet to be taken by mouth, with or without food. Follow the directions on the package carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take Pepto Bismol (bismuth subsalicylate) exactly as directed. Do not take more or less of it or take it more often than recommended by the manufacturer or your doctor.

Swallow the tablets whole; do not chew them.

Shake the liquid well before each use to mix the medication evenly.

If your symptoms get worse or if your diarrhea lasts longer than 48 hours, stop taking this medication and call your doctor.

Ask your doctor or pharmacist before taking other antacids or diarrhea medications together with Pepto Bismol (bismuth subsalicylate).

Should I take Pepto-Bismol with or without food?

Pepto-Bismol can be taken either with or without food. Use as directed for relief of travelers’ diarrhea, diarrhea or upset stomach due to overindulgence in food and drink, including: heartburn, indigestion, nausea, gas, belching and fullness.

When can I take Pepto-Bismol?

Pepto-Bismol is an upset stomach reliever and antidiarrheal product. It can be taken any time you are experiencing diarrhea, travelers’ diarrhea or an upset stomach due to overindulgence in food and drink, including: heartburn, indigestion, nausea, gas, belching and fullness. When using the product follow the directions. Do not exceed 8 doses in a 24 hour period when using Pepto-Bismol.

Before taking Pepto Bismol – Precautions

In deciding to use Pepto Bismol, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

• tell your doctor or pharmacist if you are allergic to salicylate pain relievers such as aspirin, choline magnesium trisalicylate, choline salicylate (Arthropan), diflunisal (Dolobid), magnesium salicylate (Doan’s, others), and salsalate (Argesic, Disalcid, Salgesic); or any other medication.
• check the labels of all over-the-counter (OTC), nonprescription, and prescription medicines you now take. If any contain aspirin or other salicylates, be especially careful. Using other salicylate-containing products while taking Pepto Bismol (bismuth subsalicylate) may lead to overdose. If you have any questions about this, check with your health care professional or pharmacist.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to talk to your doctor or pharmacist about taking Pepto Bismol (bismuth subsalicylate) if you take: anticoagulants (‘blood thinners’) such as warfarin (Coumadin); a daily aspirin; or medication for diabetes, arthritis or gout.
• if you are taking tetracycline antibiotics such as demeclocycline (Declomycin), doxycycline (Doryx, Vibramycin), minocycline (Dynacin, Minocin), and tetracycline (Sumycin), take them at least 1 hour before or 3 hours after taking Pepto Bismol (bismuth subsalicylate).
• ask your doctor before taking this medication if you have ever had an ulcer, bleeding problem, stools that are bloody or blackened, or kidney disease. Also ask your doctor before taking Pepto Bismol (bismuth subsalicylate) if you have a fever or mucus in your stool. If you will be giving Pepto Bismol (bismuth subsalicylate) to a child or teenager, tell the child’s doctor if the child has any of the following symptoms before he or she receives the medication: vomiting, listlessness, drowsiness, confusion, aggression, seizures, yellowing of the skin or eyes, weakness, or flu-like symptoms. Also tell the child’s doctor if the child has not been drinking normally, has had excessive vomiting or diarrhea, or appears dehydrated.
• ask your doctor about taking this medication if you are pregnant or are breast-feeding.

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

• Do not take more than 8 doses in one day (24 hours).

Shake the liquid medicine well just before you measure a dose. Measure the liquid with a special dose-measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

• The chewable tablet must be chewed before you swallow it.

Pepto Bismol (bismuth subsalicylate) can cause you to have a black or darkened tongue. This is a harmless side effect.

This medication can also cause unusual results with certain medical tests, thyroid scans, or stomach x-rays. Tell any doctor who treats you that you have recently taken Pepto Bismol (bismuth subsalicylate).

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Do not freeze.

Keep out of the reach of children. In case of Pepto Bismol overdose, call the Poison Control Helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help.

Overdose symptoms may include increased thirst, anxiety, muscle spasm, ringing in your ears, dizziness, confusion, severe headache, problems with speech or vision, severe stomach pain, or worsening diarrhea or vomiting.

Do not keep outdated medicine or medicine no longer needed.

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric patients

This medicine should NOT be used in children younger than 12 years of age. The fluid loss caused by diarrhea may result in a severe condition. In older children with diarrhea, medicine for diarrhea may be used, but it is also very important that a sufficient amount of liquids be given to replace the fluid lost by the body. If you have any questions about this, check with your health care professional.

Also, children are usually more sensitive to the effects of salicylates, especially if they have a fever or have lost large amounts of body fluid because of vomiting, diarrhea, or sweating.

The bismuth in Pepto Bismol may cause severe constipation in children.

In addition, do not use Pepto Bismol (bismuth subsalicylate) to treat nausea or vomiting in children or teenagers who have or are recovering from the flu or chickenpox. If nausea or vomiting is present, check with the child’s doctor immediately because this could be an early sign of Reye’s syndrome.

Geriatric patients

The fluid loss caused by diarrhea may result in a severe condition. For this reason, elderly persons with diarrhea should not take this medicine without first checking with their doctor. It is also very important that a sufficient amount of liquids be taken to replace the fluid lost by the body. If you have any questions about this, check with your health care professional.

Also, the elderly may be more sensitive to the effects of salicylates. This may increase the chance of side effects during treatment. In addition, the bismuth in this medicine may cause severe constipation in the elderly.

Breastfeeding

Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to Pepto Bismol (bismuth subsalicylate) should be prescribed or you should stop breastfeeding while using Pepto Bismol (bismuth subsalicylate).

Diabetic patients

• False urine sugar test results may occur if you are regularly taking large amounts of bismuth subsalicylate or other salicylates.
• Smaller doses or occasional use of Pepto Bismol (bismuth subsalicylate) usually will not affect urine sugar tests. However, check with your health care professional (especially if your diabetes is not well-controlled) if:
  • you are not sure how much salicylate you are taking every day.
  • you notice any change in your urine sugar test results.
  • you have any other questions about this possible problem

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking Pepto Bismol (bismuth subsalicylate), it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Ask a doctor or pharmacist if it is safe for you to use Pepto Bismol (bismuth subsalicylate) if you are also using any of the following drugs:

• a blood thinner such as warfarin (Coumadin, Jantoven);
• insulin or oral diabetes medications;
• probenecid (Benemid);
• an antibiotic such as doxycycline (Doryx, Oracea, Periostat, Vibramycin), minocycline (Dynacin, Minocin, Solodyn), or tetracycline (Ala-Tet, Brodspec, Panmycin, Sumycin, Tetracap);
• medication used to prevent blood clots, such as alteplase (Activase), tenecteplase (TNKase), urokinase (Abbokinase); or
• other salicylates such as aspirin, Nuprin Backache Caplet, Kaopectate, KneeRelief, Pamprin Cramp Formula, Pepto-Bismol, Tricosal, Trilisate, and others.

Using Pepto Bismol (bismuth subsalicylate) with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Aceclofenac
• Acemetacin
• Amtolmetin Guacil
• Bromfenac
• Bufexamac
• Celecoxib
• Clonixin
• Dexibuprofen
• Dexketoprofen
• Diclofenac
• Digoxin
• Dipyrone
• Droxicam
• Etodolac
• Etofenamate
• Etoricoxib
• Felbinac
• Fenoprofen
• Fepradinol
• Feprazone
• Floctafenine
• Flufenamic Acid
• Flurbiprofen
• Ibuprofen
• Indomethacin
• Ketoprofen
• Lornoxicam
• Loxoprofen
• Lumiracoxib
• Meclofenamate
• Mefenamic Acid
• Meloxicam
• Morniflumate
• Nabumetone
• Naproxen
• Nepafenac
• Niflumic Acid
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Oxaprozin
• Oxyphenbutazone
• Parecoxib
• Phenylbutazone
• Piketoprofen
• Piroxicam
• Proglumetacin
• Propyphenazone
• Proquazone
• Rofecoxib
• Sulindac
• Tenoxicam
• Tiaprofenic Acid
• Tolfenamic Acid
• Tolmetin
• Valdecoxib

Using Pepto Bismol (bismuth subsalicylate) with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Doxycycline
• Probenecid
• Sulfinpyrazone
• Tamarind

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your Pepto Bismol (bismuth subsalicylate) with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Dysentery—This condition may get worse; a different kind of treatment may be needed
• Gout—The salicylate in Pepto Bismol (bismuth subsalicylate) may worsen the gout and make the medicines taken for gout less effective
• Hemophilia or other bleeding problems—The salicylate in Pepto Bismol (bismuth subsalicylate) may increase the chance of bleeding
• Kidney disease—There is a greater chance of side effects because the body may be unable to get rid of the Pepto Bismol (bismuth subsalicylate)
• Stomach ulcer—Use of this medicine may make the ulcer worse

Pepto Bismol Pregnancy and Breastfeeding

Pepto Bismol Pregnancy Warnings

Safety has not been established during pregnancy; use is NOT recommended.

US FDA pregnancy category: Not assigned

Animal studies are inadequate. There are no controlled data in human pregnancy. Bismuth subsalicylate lacks reports of adverse fetal outcomes; however salicylates may cause congenital defects, increased perinatal mortality from ductus arteriosus in utero, intrauterine growth restriction, and salicylate intoxication.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D and X are being phased out.

Although the risk for toxicity may be small, significant fetal adverse effects have resulted from chronic exposure to salicylates Because of this, the use of bismuth subsalicyate during gestation should be restricted to the first half of pregnancy and then only in amounts that do not exceed the recommended doses ².

Pepto Bismol Breastfeeding Warnings

Use is NOT recommended.

Excreted into human milk: Yes

The excretion of large amounts of bismuth obtained from bismuth subsalicylate into breast milk is not expected because of the poor absorption of bismuth into the systemic circulation. Salicylates, however, are excreted in milk and are eliminated more slowly from milk than from plasma with milk:plasma ratios, rising from 0.03-0.08 at 3 hours to 0.34 at 12 hours ². Due to the potential for adverse effects in the nursing infant, the American Academy of Pediatrics recommends that salicylates should be used cautiously during breast feeding. A recent review also states that bismuth subsalicylate should be avoided during lactation because of systemic salicylate absorption.

Comments:

• Bismuth is not expected to appear in high concentrations in breast milk due to poor systemic absorption.
• Salicylates are excreted in breast milk.

What does Pepto Bismol do

Relieves travelers’ diarrhea, diarrhea and upset stomach due to over indulgence in food and drink including: heartburn, indigestion, nausea, gas, belching and fullness.

 

Pepto Bismol uses

Make certain your health care professional knows if you are on any special diet, such as a low-sodium or low-sugar diet.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

For safe and effective use of Pepto Bismol (bismuth subsalicylate):

• Follow your doctor’s instructions if Pepto Bismol (bismuth subsalicylate) was prescribed.
• Follow the manufacturer’s package directions if you are treating yourself.

For patients using Pepto Bismol (bismuth subsalicylate) to treat diarrhea:

• It is very important that the fluid lost by the body be replaced and that a proper diet be followed. For the first 24 hours you should drink plenty of clear liquids, such as ginger ale, decaffeinated cola, decaffeinated tea, broth, and gelatin. During the next 24 hours you may eat bland foods, such as cooked cereals, bread, crackers, and applesauce. Fruits, vegetables, fried or spicy foods, bran, candy, and caffeine and alcoholic beverages may make the diarrhea worse.
• If too much fluid has been lost by the body due to the diarrhea a serious condition may develop. Check with your doctor as soon as possible if any of the following signs of too much fluid loss occur:
  • Decreased urination
  • Dizziness and lightheadedness
  • Dryness of mouth
  • Increased thirst
  • Wrinkled skin

If you are taking the oral suspension

• Use the dose cup that is included to measure out the right amount of Pepto Bismol (bismuth subsalicylate). If you are unsure, contact your doctor or pharmacist.

If you are taking the oral tablets

• Swallow the tablet whole with a glass of water. Do not crush or chew the tablet.

If you are taking the chewable tablets

• Chew up the tablet or allow it to completely disintegrate in your mouth before swallowing it.

Pepto Bismol Dosing

Pepto Bismol (bismuth subsalicylate) is used to treat diarrhea, nausea, heartburn, indigestion, and upset stomach.

Pepto Bismol (bismuth subsalicylate) should NOT be given to a child or teenager who has a fever, especially if the child also has flu symptoms or chicken pox. Salicylates can cause a serious and sometimes fatal condition called Reye’s syndrome in children.

You should not use Pepto Bismol (bismuth subsalicylate) if you have a stomach ulcer, a recent history of stomach or intestinal bleeding, or if you are allergic to salicylates such as aspirin, Doan’s Extra Strength, Salflex, Tricosal, and others.

• The dose of Pepto Bismol (bismuth subsalicylate) will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of Pepto Bismol (bismuth subsalicylate). If your dose is different, do not change it unless your doctor tells you to do so.

The amount of Pepto Bismol (bismuth subsalicylate) that you take depends on the strength of the Pepto Bismol (bismuth subsalicylate) medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For oral dosage form (Pepto Bismol suspension):

• For diarrhea or upset stomach:
  • Adults and children 12 years of age and older—The usual dose is 2 tablespoonfuls every half-hour to one hour if needed. You should not take more than 16 tablespoonfuls of the regular-strength suspension or 8 tablespoonfuls of the concentrate in twenty-four hours.
  • Children under 12 years—Should NOT be used in children younger than 12 years of age.

For oral dosage forms (Pepto Bismol tablets or chewable tablets):

• For diarrhea or upset stomach:
  • Adults and children 12 years of age and older—The usual dose is 2 tablets every half-hour to one hour. You should not take more than 16 tablets in twenty-four hours.
  • Children under 12 years—Should NOT be used in children younger than 12 years of age.

Usual Adult Dose for Dyspepsia

524 mg orally every 30 to 60 minutes as needed not to exceed 8 doses in any 24 hour period.

Alternatively, 1048 mg to 1050 mg may be given orally every hour not to exceed 4 doses in any 24 hour period.

Comments:

• Use until diarrhea stops but not longer than 2 days.
• Pepto Bismol (bismuth subsalicylate) may be useful in the prevention of traveler’s diarrhea during periods of risk. The duration of use for traveler’s diarrhea should not exceed approximately 3 weeks.
• -Shake liquid formulations well before using.

Usual Adult Dose for Traveler’s Diarrhea

524 mg orally every 30 to 60 minutes as needed not to exceed 8 doses in any 24 hour period.

Alternatively, 1048 mg to 1050 mg may be given orally every hour not to exceed 4 doses in any 24 hour period.

Comments:

• Use until diarrhea stops but not longer than 2 days.
• Pepto Bismol (bismuth subsalicylate) may be useful in the prevention of traveler’s diarrhea during periods of risk. The duration of use for traveler’s diarrhea should not exceed approximately 3 weeks.
• Shake liquid formulations well before using.

Usual Adult Dose for Diarrhea

524 mg orally every 30 to 60 minutes as needed not to exceed 8 doses in any 24 hour period.

Alternatively, 1048 mg to 1050 mg may be given orally every hour not to exceed 4 doses in any 24 hour period.

Comments:

• Use until diarrhea stops but not longer than 2 days.
• Pepto Bismol (bismuth subsalicylate) may be useful in the prevention of traveler’s diarrhea during periods of risk. The duration of use for traveler’s diarrhea should not exceed approximately 3 weeks.
• Shake liquid formulations well before using.

Usual Adult Dose for Helicobacter pylori Infection

524 mg orally 4 times a day.

Usual Pediatric Dose for Diarrhea

Non-specific diarrhea:

• <3 years: Ask your doctor
• 3 to 6 years: Use with caution, 87 mg every 30 minutes to 1 hour as needed.
• 6 to 9 years: Use with caution, 175 mg every 30 minutes to 1 hour as needed.
• 9 to 12 years: Use with caution, 262 mg every 30 minutes to 1 hour as needed.

Usual Pediatric Dose for Chronic Diarrhea

Chronic Infantile Diarrhea:

• 2 to 24 months: Use with caution, 44 mg every 4 hours
• 24 to 48 months: Use with caution, 87 mg every 4 hours
• 48 to 70 months: Use with caution, 175 mg every 4 hours

Usual Pediatric Dose for Helicobacter pylori Infection

Dosage in children with Helicobacter Pylori Infection is not well established, the following doses have been used in conjunction with ampicillin and metronidazole.

• <= 10 years: 262 mg four times a day for six weeks
• > 10 years: 524 mg four times a day for six weeks

Renal Dose Adjustments

• Data not available

Liver Dose Adjustments

• Data not available

Dialysis

• Data not available

What should I do if I forget a dose?

Pepto Bismol (bismuth subsalicylate) is usually taken as needed. If your doctor has told you to take Pepto Bismol (bismuth subsalicylate) regularly, take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What special dietary instructions should I follow?

Drink plenty of water or other beverages to replace fluids that you may have lost while having diarrhea.

Unless your doctor tells you otherwise, continue your normal diet.

What should I do if I forget a dose?

This medication is usually taken as needed. If your doctor has told you to take bismuth subsalicylate regularly, take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Pepto Bismol dosage

Pepto Bismol Liquid

Active Ingredient: Bismuth Subsalicylate 525 mg in each 30 ml dose

Inactive Ingredients: Benzoic Acid, D&C Red No. 22, D&C Red No. 28, Flavor, Gellan Gum, Magnesium Aluminum Silicate, Methylcellulose, Salicylic Acid, Sodium Salicylate, Sorbic Acid, Sucralose, Water

Storage Instructions

• Protect from freezing. Avoid excessive heat (over 104°F or 40°C).

Pepto Bismol Liquid Usage Warning

Reye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye’s syndrome, a rare but serious illness.

Allergy alert: Contains salicylate. Do not take if you are allergic to salicylates (including aspirin), taking other salicylate products.

Do not use if you have an ulcer, a bleeding problem, bloody or black stool. Ask a doctor before use if you have: fever, mucus in the stool.

Ask a doctor or pharmacist before use if you are taking any drug for: anticoagulation (thinning the blood), diabetes, gout, arthritis. When using this product a temporary, but harmless, darkening of the stool and/or tongue may occur.

Stop use and ask a doctor if: symptoms get worse or last more than 2 days.

Pepto Bismol Liquid directions of use

• Shake well before use.
• Only use dose cup provided.

Pepto Bismol Liquid Dosage

• Adults and children 12 years and over:
  • 30 mL (1 dose) every ½ hour or 60 mL (2 doses) every hour as needed for diarrhea/traveler’s diarrhea. Use until diarrhea stops but not more than 2 days. Drink plenty of clear fluids to help prevent dehydration caused by diarrhea.
  • 30 mL (1 dose) every ½ hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea).
  • Do not exceed 8 doses (240 mL) in 24 hours.
• Children under 12 years: ask a doctor.

Pepto-Bismol Swallowable Caplets

Active Ingredient: Bismuth Subsalicylate 262 mg in each caplet

Inactive Ingredients: Calcium Carbonate, Magnesium Stearate, Mannitol, Microcrystalline Cellulose, Polysorbate 80, Povidone, D&C Red No. 27 Aluminum Lake, Silicon Dioxide, Sodium Starch Glycolate

Storage Instructions

• Avoid excessive heat (over 104°F or 40°C)

Pepto-Bismol Swallowable Caplets Usage Warning

Reye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye’s syndrome, a rare but serious illness.

Allergy alert: Contains salicylate. Do not take if you are allergic to salicylates (including aspirin), taking other salicylate products.

Do not use if you have an ulcer, a bleeding problem, bloody or black stool. Ask a doctor before use if you have: fever, mucus in the stool.

Ask a doctor or pharmacist before use if you are taking any drug for: anticoagulation (thinning the blood), diabetes, gout, arthritis. When using this product a temporary, but harmless, darkening of the stool and/or tongue may occur.

Stop use and ask a doctor if: symptoms get worse or last more than 2 days.

Pepto-Bismol Swallowable Caplets directions of use

• Swallow whole with water, do not chew.

Pepto-Bismol Swallowable Caplets Dosage

• Adults and children 12 years and over:
  • 2 caplets (1 dose) every ½ hour or 4 caplets (2 doses) every hour as needed for diarrhea. Use until diarrhea stops but not more than 2 days. Drink plenty of clear fluids to help prevent dehydration caused by diarrhea.
  • 2 caplets (1 dose) every ½ hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea).
  • Do not exceed 8 doses (16 caplets) in 24 hours.
• Children under 12 years: ask a doctor.

Pepto-Bismol Original Chewable Tablets

Active Ingredient: Bismuth Subsalicylate 262 mg in each chewable tablet

Inactive Ingredients: Calcium Carbonate, Flavor, Magnesium Stearate, Mannitol, Povidone, D&C Red No. 27, Saccharin Sodium, Talc

Storage Instructions

• Avoid excessive heat (over 104°F or 40°C)

Pepto-Bismol Original Chewable Tablets Usage Warning

Reye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye’s syndrome, a rare but serious illness.

Allergy alert: Contains salicylate. Do not take if you are allergic to salicylates (including aspirin), taking other salicylate products.

Do not use if you have an ulcer, a bleeding problem, bloody or black stool. Ask a doctor before use if you have: fever, mucus in the stool.

Ask a doctor or pharmacist before use if you are taking any drug for: anticoagulation (thinning the blood), diabetes, gout, arthritis. When using this product a temporary, but harmless, darkening of the stool and/or tongue may occur.

Stop use and ask a doctor if: symptoms get worse or last more than 2 days.

Pepto-Bismol Original Chewable Tablets directions of use

• Chew or dissolve in mouth.

Pepto-Bismol Original Chewable Tablets Dosage

• Adults and children 12 years and over:
  • 2 tablets (1 dose) every ½ hour or 4 tablets (2 doses) every hour as needed for diarrhea. Use until diarrhea stops but not more than 2 days. Drink plenty of clear fluids to help prevent dehydration caused by diarrhea.
  • 2 tablets (1 dose) every ½ hour as needed for overindulgence (upset stomach, heartburn, indgestion and nausea).
  • Do not exceed 8 doses (16 tablets) in 24 hours.
• Children under 12 years: ask a doctor.

Children’s Pepto Antacid

Active Ingredient: Calcium Carbonate 400 mg in each Children’s Pepto Antacid chewable tablet

Inactive Ingredients: D&C Red No.27 Aluminum Lake, Flavor, Magnesium Stearate, Mannitol, Povidone, Sorbitol, Sugar, Talc

Storage Instructions

• Do not exceed 25°C. Preserve in well-closed containers.

Children’s Pepto Antacid Chewable Tablets Usage Warning

Ask a doctor or pharmacist before use if the child is presently taking a prescription drug. Antacids may interact with certain prescription drugs. Stop use and ask a doctor if symptoms last more than two weeks. Keep this and all drugs out of the reach of children.

Children’s Pepto Antacid Chewable Tablets directions of use

Ask a doctor or pharmacist before use.

Children’s Pepto Antacid Chewable Tablets Dosage

Find the right dose on the chart below based on weight (preferred). Otherwise, use age. Repeat dose as needed. Do not take more than 3 tablets (ages 2-5) or 6 tablets (ages 6-11) in a 24-hour period, or use the maximum dosage for more than two weeks, except under the advice and supervision of a doctor.

• Under 24 lbs or under 2 years: Ask a doctor
• 24-47 lbs or 2-5 years: 1 Children’s Pepto Antacid tablet
• 48-95 lbs or 6-11 years: 2 Children’s Pepto Antacid tablets
• Do not take more than 3 tablets (ages 2-5) or 6 tablets (ages 6-11) in a 24-hour period.

Pepto Bismol side effects

Along with Pepto Bismol (bismuth subsalicylate) needed effects, Pepto Bismol (bismuth subsalicylate) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Common side effects include:

• constipation
• dark colored stools
• black or darkened tongue.

Check with your doctor immediately if any of the following side effects occur:

In some patients Pepto Bismol (bismuth subsalicylate) may cause dark tongue and/or grayish black stools. This is only temporary and will go away when you stop taking this medicine.

Pepto Bismol side effects

• anxiety
• any loss of hearing
• confusion
• constipation (severe)
• diarrhea (severe or continuing)
• difficulty in speaking or slurred speech
• dizziness or lightheadedness
• drowsiness (severe)
• fast or deep breathing
• headache (severe or continuing)
• increased sweating
• increased thirst
• mental depression
• muscle spasms (especially of face, neck, and back)
• muscle weakness
• nausea or vomiting (severe or continuing)
• ringing or buzzing in ears (continuing)
• stomach pain (severe or continuing)
• trembling
• uncontrollable flapping movements of the hands (especially in elderly patients) or other uncontrolled body movements
• vision problems

Nervous system

• Rare (less than 0.1%): Myoclonic encephalopathy
• Frequency not reported: Weakness, fatigue, depression, anxiety, irritability, insomnia, unsteady gait, motor incoordination, loss of memory, jerky movements, mental confusion, disorientation, difficulty in walking and speaking, tremor, myoclonic jerks, incontinence

Nervous system toxicity is a common feature of bismuth toxicity. Bismuth toxicity is characterized by the insidious onset of weakness and fatigue, depression, anxiety, irritability, insomnia, unsteady gait, motor incoordination, loss of memory, and jerky movements. Acute toxicity may result in the development of mental confusion, disorientation, difficulty in walking and speaking, tremor, myoclonic jerks, and incontinence.

Myoclonic encephalopathy has occurred in patients who have ingested bismuth for several months to years, but the incidence is very rare. Recovery of patients from bismuth encephalopathy may take several months following discontinuation of use. Bismuth encephalopathy has generally been reported in patients ingesting salts other than subsalicylate.

Other

Salicylism has been reported in patients who chronically ingest bismuth subsalicylate (the active ingredient contained in Pepto-Bismol). Common complaints include vertigo, diminished hearing, lethargy, CNS (central nervous system) dysfunction, confusion, tinnitus, vomiting, and abdominal pain. Patients may present with respiratory alkalosis and metabolic acidosis, azotemia, and hypoprothrombinemia and platelet dysfunction. The elderly may be particularly vulnerable to the development of salicylism.

Frequency not reported: Salicylism

Gastrointestinal

• Very common (10% or more): Black stool
• Common (1% to 10%): Black tongue
• Frequency not reported: Nausea, vomiting

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Some side effects can be serious.

If you experience this symptom, stop taking this medication and call your doctor immediately:

• ringing or buzzing in your ear(s)
• diarrhea lasting longer than 2 days
• worsened stomach symptoms.

Pepto Bismol (bismuth subsalicylate) may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

Human Toxicity Reports

Six examples of poisoning by bismuth subsalicylate were reported ³ arising from treatment of syphilis involving the simultaneous occurrence of stomatitis and albuminuria. The study author noted that bismuth tended to be mobilized during acidosis and advised caution in administration of bismuth to patients subject to acidosis ³.

A case was described in which encephalopathy occurred in a 60 year old man that was attributed to use of  bismuth subsalicylate for diarrhea ⁴. The diagnosis was supported by an electroencephalogram and a blood bismuth level of 72 uG/L. The patient recovered completely within one month after the drug was discontinued ⁴.

Inorganic bismuth salts, formed from metabolism of bismuth subsalicylate in the gastrointestinal tract, apparently present little or no risk to the fetus from normal therapeutic doses, but the data available for bismuth in pregnancy are poor, and the actual fetal risk cannot be determined ². On the other hand, the potential actions of salicylate on the fetus are complex. Although the risk for toxicity may be small, significant fetal adverse effects have resulted from chronic exposure to salicylates. Because of this, the use of bismuth subsalicyate during gestation should be restricted to the first half of pregnancy and then only in amounts that do not exceed the recommended doses ².

Bioavailability of doxycycline was significantly reduced by 37% and 51% respectively, when bismuth subsalicylate was given simultaneously and as a multiple dose regimen before doxycycline. Bismuth subsalicylate should not be taken when doxycycline is used for therapeutic purposes. The study authors suggest travelers should not take these agents together to prevent diarrhea ⁵.

Pepto Bismol overdose

In case of Pepto Bismol overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can’t be awakened, immediately call your emergency services number.

Moderately toxic and probable oral lethal dose in human is 500mg to 5,000mg per kg body weight for a 70 kg (150 lb) person ⁶.

If you think that you or anyone else may have taken a Pepto Bismol overdose, get emergency help at once. Taking an overdose of Pepto Bismol (bismuth subsalicylate) may cause unconsciousness or death. Signs of overdose include convulsions (seizures), hearing loss, confusion, ringing or buzzing in the ears, severe drowsiness or tiredness, severe excitement or nervousness, and fast or deep breathing.

References

1. BISMUTH SUBSALICYLATE. https://toxnet.nlm.nih.gov/cgi-bin/sis/search2/f?./temp/~nTtVSk:1
2. Briggs, G.G, R.K. Freeman, S.J. Yaffe. A Reference Guide to Fetal and Neonatal Risk. Drugs in Pregnancy and Lactation. 4th ed. Baltimore, MD: Williams & Wilkins 1994., p. 96
3. Hayes, W.J., Jr., E.R. Laws, Jr., (eds.). Handbook of Pesticide Toxicology. Volume 2. Classes of Pesticides. New York, NY: Academic Press, Inc., 1991., p. 543
4. HASKING GJ, DUGGAN JM; MED J AUST 2 (AUG 21): 167;1982
5. Influence of Subsalicylate Bismuth on Absorption of Doxycycline; JAMA 247 (16): 2266; 1982 https://jamanetwork.com/journals/jama/article-abstract/371748
6. Gosselin, R.E., H.C. Hodge, R.P. Smith, and M.N. Gleason. Clinical Toxicology of Commercial Products. 4th ed. Baltimore: Williams and Wilkins, 1976., p. II-93

What is Zantac

Zantac (Ranitidine) is in a class of medications called histamine-2 blockers (H2 blockers). Zantac active ingredient is called Ranitidine, which is a histamine-2 antagonist or H2 blocker. Zantac (Ranitidine) works by reducing the amount of acid your stomach produces. Histamine is a chemical that occurs naturally in the body. It encourages your stomach to produce acid which it needs to digest your food. By blocking the histamine, Zantac (Ranitidine) reduces the amount of acid your stomach produces. Having less acid in your stomach allows ulcers and inflammation to heal. If your foodpipe (esophagus) has been damaged by stomach acid, this will also have a chance to heal.

Zantac (Ranitidine) is used to treat and prevent ulcers in the stomach and intestines. Zantac (Ranitidine) also treats conditions in which the stomach produces too much acid, such as Zollinger-Ellison syndrome. Zantac (Ranitidine) also treats gastroesophageal reflux disease (GERD) and other conditions in which acid backs up from the stomach into the esophagus, causing heartburn and injury of the food pipe (esophagus).

Over-the-counter Zantac (Ranitidine) is used to prevent and treat symptoms of heartburn associated with acid indigestion and sour stomach.

Key facts

• It’s usual to take Zantac (Ranitidine) once or twice a day.
• Some people only need to take Zantac (Ranitidine) for a short time, when they have symptoms. Others need to take it for longer.
• You can take Zantac (Ranitidine) with or without food.
• It’s unusual to get any side effects. However, some people may get stomach pain or constipation, or feel sick (nausea). This tends to get better as you carry on taking Zantac (Ranitidine).
• Ranitidine is called by the brand names Zantac, Zantac 75, Zantac EFFERdose, Zantac Syrup and Taladine

How long does Zantac take to work

Your indigestion and heartburn should start to feel better within 1 or 2 hours. The effects will usually last for around 12 hours.

It may take a few weeks for Zantac (Ranitidine) to work properly. Depending on your problems, you may still have some acid symptoms during this time.

If you’re taking Zantac (Ranitidine) to prevent stomach ulcers, however, you may not feel any different. Carry on taking your medicine. It will still be working.

How long will I take Zantac for?

If you’re taking lower strength Zantac (Ranitidine) (75mg) that you bought from a pharmacy or supermarket, speak to a pharmacist or doctor before starting on a second packet. They may recommend tests to find out what’s causing your symptoms, if taking Zantac (Ranitidine) hasn’t cleared them up.

If your doctor prescribes Zantac (Ranitidine) for you, you may only need to take it for a few weeks or months, depending on your health problem. Sometimes you might need to take it for longer.

Your doctor may suggest taking Zantac (Ranitidine) only when you have symptoms. This means you won’t have to take it every day. Once you feel better, you can stop taking it – often after a few days or weeks.

Taking Zantac (Ranitidine) this way isn’t suitable for everyone. Speak to your doctor about what’s best for you.

Although Zantac (Ranitidine) appears to only minimally affect the secretion of gastric intrinsic factor, malabsorption of, and resultant deficiency in vitamin B12 may occur during long-term ranitidine therapy ¹.

Zantac side effects long term

It’s usually best to take Zantac (Ranitidine) for a short time. You might take it for a month or two, for example, until your stomach heals. Some people may take it every now and again when they have symptoms. You may find that Zantac (Ranitidine) stops working and your symptoms come back if you take it for longer than this.

If you’re taking Zantac (Ranitidine) to treat Zollinger Ellison syndrome or another long term problem, however, you may need to take it for longer. In this case, follow your doctor’s instructions about the best way to take it.

Are there similar medicines to Zantac?

There are 3 other medicines that are similar to Zantac (Ranitidine). They are cimetidine, famotidine and nizatidine.

Like Zantac (Ranitidine), these medicines are H2 blockers. They work in the same way as Zantac (Ranitidine) to reduce the amount of acid in your stomach.

Famotidine and nizatidine generally work as well as Zantac (Ranitidine) and have similar side effects. However they may suit some people better.

Cimetidine can interfere with lots of medicines and has more side effects than other H2 blockers.

Are there other indigestion medicines?

Yes there are other pharmacy and prescription medicines for indigestion and heartburn.

Antacids, like calcium carbonate (Tums or Mylanta), sodium bicarbonate (Neut), Maalox and Milk of Magnesia, relieve indigestion and heartburn by neutralizing the acid in your stomach. They give quick relief that lasts for a few hours. They’re ideal for occasional stomach acid symptoms.

Some antacids, such as Gaviscon, have an extra ingredient called alginic acid. They work by lining your stomach so that juices from it don’t splash up into your foodpipe. They’re especially good for relieving acid reflux.

Antacids are available from pharmacies and supermarkets.

Proton pump inhibitors (PPIs) reduce the amount of acid made in your stomach, but they do this in a different way to H2 blockers.

They include esomeprazole (Nexium), lansoprazole (Zoton FasTabs), omeprazole (Losec), pantoprazole (Pantoloc Control) and rabeprazole (Pariet).

In general, proton pump inhibitors (PPIs) are used first because they are better than H2 blockers at reducing stomach acid. Your doctor may prescribe an H2 blocker if you don’t get on with a  proton pump inhibitor (PPI) – for example because of the side effects.

Lansoprazole and rabeprazole are only available on prescription but you can buy omeprazole, esomeprazole and pantoprazole directly from pharmacies. You can also buy esomeprazole from supermarkets.

Can I take Zantac with other indigestion medicines?

Some antacids are okay to take at the same time as Zantac (Ranitidine). Other antacids, such as Gaviscon, need to be taken a certain amount of time before or after you take the Zantac (Ranitidine). Check the instructions on the packet to see how long you need to wait between medicines.

Sometimes, depending on your symptoms, your doctor may prescribe an H2 blocker as well as a proton pump inhibitor. This will often be for a short time and you’ll usually take the H2 blocker at night.

If you’re prescribed sucralfate (a medicine to treat ulcers), take it at least 2 hours after Zantac (Ranitidine). This is because sucralfate can stop your body from properly absorbing the Zantac (Ranitidine).

Can I drive or ride a bike after taking Zantac?

Occasionally, Zantac (Ranitidine) can make you feel dizzy or sleepy, or give you blurred vision. If this happens to you, don’t drive, cycle or use machinery or tools until you feel better.

Furthermore, the amount of alcohol contained in a large dose of Zantac (Ranitidine) liquid may affect your ability to drive or operate machines. In this case, do not attempt to drive or use any machinery.

Can I drink alcohol with Zantac?

Yes, you can drink alcohol with Zantac (Ranitidine) but be aware that Zantac (Ranitidine) liquid also contains a small amount of alcohol.

Also, drinking alcohol makes your stomach produce more acid than normal. This can irritate your stomach lining and make your symptoms worse.

Is there any food or drink I need to avoid?

You can eat and drink normally while taking Zantac (Ranitidine).

However, it’s best to avoid foods that seem to make your indigestion worse, such as rich, spicy and fatty foods. You may also want to cut down on caffeinated drinks, such as tea, coffee and cola, as well as alcohol.

Can lifestyle changes help?

It may be possible to ease symptoms caused by too much stomach acid by making a few changes to your diet and lifestyle:

• lose excess weight
• don’t eat foods that can make your symptoms worse, such as rich, spicy and fatty foods, and acidic foods like tomatoes, citrus fruits, salad dressings and fizzy drinks
• cut down on caffeinated drinks, such as tea, coffee and cola, as well as alcohol and smoking
• if you have symptoms at night, try not to eat for at least 3 hours before you go to bed
• raise the head of your bed by 10 to 20cm, so your head and chest are higher than your waist

Who can and can’t take Zantac

Zantac (Ranitidine) can be taken by adults. It can also be given to children under 16 years of age on prescription.

Zantac (Ranitidine) isn’t suitable for some people. To make sure that it is safe for you, tell your doctor if you:

• have had an allergic reaction to Zantac (Ranitidine) or any other medicines in the past
• have kidney problems
• have an intolerance to, or cannot absorb, some sugars such as fructose
• have been advised to eat a low calcium or low salt diet
• cannot have alcohol – Zantac (Ranitidine) liquid contains a small amount of alcohol
• have phenylketonuria (PKU), a rare inherited illness

If you’re due to have an endoscopy to find out what’s causing your symptoms, stop taking Zantac (Ranitidine) at least 2 weeks before your procedure. This is because Zantac (Ranitidine) may hide some of the problems that would usually be spotted during an endoscopy.

Pediatric Use

The safety and effectiveness of Zantac have been established in the age-group of 1 month to 16 years for the treatment of duodenal and gastric ulcers, gastroesophageal reflux disease and erosive esophagitis, and the maintenance of healed duodenal and gastric ulcer. Use of Zantac in this age-group is supported by adequate and well-controlled trials in adults, as well as additional pharmacokinetic data in pediatric patients and an analysis of the published literature.

Safety and effectiveness in pediatric patients for the treatment of pathological hypersecretory conditions or the maintenance of healing of erosive esophagitis have not been established.

Safety and effectiveness in neonates (aged younger than 1 month) have not been established.

Geriatric Use

Of the total number of subjects enrolled in US and foreign controlled clinical trials of oral formulations of Zantac, for which there were subgroup analyses, 4,197 were aged 65 and older, while 899 were aged 75 and older. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

This drug is known to be substantially excreted by the kidney and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, caution should be exercised in dose selection, and it may be useful to monitor renal function.

Pregnancy and breastfeeding

Tell your pharmacist or doctor if you’re trying to get pregnant, are already pregnant or if you’re breastfeeding.

Usually, Zantac (Ranitidine) is safe to take during pregnancy and while breastfeeding. Animal models have failed to reveal evidence of impaired fertility or fetal harm. It is unknown whether use of gastric-suppressing drugs are associated with childhood allergy and asthma. There are no controlled data in human pregnancy.

If you’re pregnant, it’s always better to try to treat indigestion without taking a medicine.

Your doctor or midwife will first advise you to try to ease your symptoms by eating smaller meals more often, and not eating fatty and spicy foods. They may also suggest raising the head of your bed by 10 to 20cm, so your head and chest are higher than your waist. This will help stop stomach acid travelling up towards your throat.

If these lifestyle changes don’t work, you may be recommended a medicine like Zantac (Ranitidine).

Teratogenic Effects

Pregnancy Category B. Reproduction studies have been performed in rats and rabbits at doses up to 160 times the human dose and have revealed no evidence of impaired fertility or harm to the fetus due to Zantac (Ranitidine). There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Carcinogenesis, Mutagenesis, Impairment of Fertility

There was no indication of tumorigenic or carcinogenic effects in life-span studies in mice and rats at dosages up to 2,000 mg/kg/day.

Zantac (Ranitidine) was not mutagenic in standard bacterial tests (Salmonella, Escherichia coli) for mutagenicity at concentrations up to the maximum recommended for these assays.

In a dominant lethal assay, a single oral dose of 1,000 mg/kg to male rats was without effect on the outcome of 2 matings per week for the next 9 weeks.

Zantac and breastfeeding

Zantac (Ranitidine) is safe to take while you’re breastfeeding. It passes into breast milk, but only in small amounts which aren’t harmful to the baby.

However, if your baby is premature or has health problems check with your doctor first.

Cautions with other medicines

For safety, tell your pharmacist or doctor if you’re taking other medicines including herbal remedies, vitamins or supplements.

Some medicines can interfere with Zantac (Ranitidine) and make you more likely to have side effects.

Tell your doctor if you’re taking these medicines before you start taking Zantac (Ranitidine):

• anti-fungal medicines such as itraconazole, ketoconazole or posaconazole
• any medicine used to treat cancer
• HIV medicines

Zantac (Ranitidine) has been reported to affect the bioavailability of other drugs through several different mechanisms such as competition for renal tubular secretion, alteration of gastric pH, and inhibition of cytochrome P450 enzymes.

Procainamide: Zantac (Ranitidine), a substrate of the renal organic cation transport system, may affect the clearance of other drugs eliminated by this route. High doses of Zantac (Ranitidine) (e.g., such as those used in the treatment of Zollinger-Ellison syndrome) have been shown to reduce the renal excretion of procainamide and N-acetylprocainamide resulting in increased plasma levels of these drugs. Although this interaction is unlikely to be clinically relevant at usual Zantac (Ranitidine) doses, it may be prudent to monitor for procainamide toxicity when administered with oral Zantac (Ranitidine) at a dose exceeding 300 mg per day.

Warfarin: There have been reports of altered prothrombin time among patients on concomitant warfarin and Zantac (Ranitidine) therapy. Due to the narrow therapeutic index, close monitoring of increased or decreased prothrombin time is recommended during concurrent treatment with Zantac (Ranitidine).

Zantac (Ranitidine) may alter the absorption of drugs in which gastric pH is an important determinant of bioavailability. This can result in either an increase in absorption (e.g., triazolam, midazolam, glipizide) or a decrease in absorption (e.g., ketoconazole, atazanavir, delavirdine, gefitinib). Appropriate clinical monitoring is recommended.

Atazanavir: Atazanavir absorption may be impaired based on known interactions with other agents that increase gastric pH. Use with caution. See atazanavir label for specific recommendations.

Delavirdine: Delavirdine absorption may be impaired based on known interactions with other agents that increase gastric pH. Chronic use of H2-receptor antagonists with delavirdine is not recommended.

Gefitinib: Gefitinib exposure was reduced by 44% with the coadministration of Zantac (Ranitidine) and sodium bicarbonate (dosed to maintain gastric pH above 5.0). Use with caution.

Glipizide: In diabetic patients, glipizide exposure was increased by 34% following a single 150-mg dose of oral Zantac (Ranitidine). Use appropriate clinical monitoring when initiating or discontinuing Zantac (Ranitidine).

Ketoconazole: Oral ketoconazole exposure was reduced by up to 95% when oral Zantac (Ranitidine) was coadministered in a regimen to maintain a gastric pH of 6 or above. The degree of interaction with usual dose of Zantac (Ranitidine) (150 mg twice daily) is unknown.

Midazolam: Oral midazolam exposure in 5 healthy volunteers was increased by up to 65% when administered with oral Zantac (Ranitidine) at a dose of 150 mg twice daily. However, in another interaction trial in 8 volunteers receiving IV midazolam, a 300-mg oral dose of Zantac (Ranitidine) increased midazolam exposure by about 9%. Monitor patients for excessive or prolonged sedation when Zantac (Ranitidine) is coadministered with oral midazolam.

Triazolam: Triazolam exposure in healthy volunteers was increased by approximately 30% when administered with oral Zantac (Ranitidine) at a dose of 150 mg twice daily. Monitor patients for excessive or prolonged sedation.

These are not all the medicines that may not mix well with Zantac (Ranitidine). For a full list see the leaflet inside your medicines packet.

Mixing Zantac (Ranitidine) with herbal remedies and supplements

There isn’t enough research to know if complementary medicines and herbal remedies are safe to take with Zantac (Ranitidine).

What is Zantac used for

Zantac (Ranitidine) comes as a tablet, an effervescent tablet, effervescent granules, and a syrup to take by mouth. It is usually taken once a day at bedtime or two to four times a day. Over-the-counter Zantac (Ranitidine) comes as a tablet to take by mouth. It is usually taken once or twice a day. To prevent symptoms, it is taken 30 to 60 minutes before eating or drinking foods that cause heartburn. Follow the directions on your prescription or the package label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take Zantac (Ranitidine) exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Dissolve Zantac (Ranitidine) effervescent tablets and granules in a full glass (6 to 8 ounces [180 to 240 milliliters]) of water before drinking.

Do not take over-the-counter Zantac (Ranitidine) for longer than 2 weeks unless your doctor tells you to. If symptoms of heartburn, acid indigestion, or sour stomach last longer than 2 weeks, stop taking Zantac (Ranitidine) and call your doctor.

Zantac (Ranitidine) is also used sometimes to treat upper gastrointestinal bleeding and to prevent stress ulcers, stomach damage from use of nonsteroidal anti-inflammatory drugs (NSAIDs), and aspiration of stomach acid during anesthesia. Talk to your doctor about the risks of using this medication for your condition.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Zantac uses

Zantac (Ranitidine) reduces the amount of acid your stomach makes.

• Short-term treatment of active duodenal ulcer. Most patients heal within 4 weeks. Trials available to date have not assessed the safety of Zantac (Ranitidine) in uncomplicated duodenal ulcer for periods of more than 8 weeks.
• Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of acute ulcers. No placebo-controlled comparative trials have been carried out for periods of longer than 1 year.
• The treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome and systemic mastocytosis).
• Short-term treatment of active, benign gastric ulcer. Most patients heal within 6 weeks and the usefulness of further treatment has not been demonstrated. Trials available to date have not assessed the safety of Zantac (Ranitidine) in uncomplicated, benign gastric ulcer for periods of more than 6 weeks.
• Maintenance therapy for gastric ulcer patients at reduced dosage after healing of acute ulcers. Placebo-controlled trials have been carried out for 1 year.
• Treatment of gastro-esophageal reflux disease (GERD). Symptomatic relief commonly occurs within 24 hours after starting therapy with Zantac 150 mg twice daily.
• Treatment of endoscopically diagnosed erosive esophagitis. Symptomatic relief of heartburn commonly occurs within 24 hours of therapy initiation with Zantac 150 mg 4 times daily.
• Maintenance of healing of erosive esophagitis. Placebo-controlled trials have been carried out for 48 weeks.

Concomitant antacids should be given as needed for pain relief to patients with active duodenal ulcer; active, benign gastric ulcer; hypersecretory states; GERD; and erosive esophagitis.

Zantac (Ranitidine) is also taken to prevent and treat stomach ulcers.

Sometimes, Zantac (Ranitidine) is taken for a rare illness caused by a tumor in the pancreas or gut called Zollinger-Ellison syndrome.

Zantac (Ranitidine) comes as tablets, soluble (dispersible) tablets that dissolve in water to make a drink, or as a liquid that you drink.

All types of Zantac (Ranitidine) are available on prescription. You can also buy the lowest strength 75mg tablets from pharmacies and supermarkets.

Before taking Zantac – Precautions

• tell your doctor and pharmacist if you are allergic to Zantac (Ranitidine) or any other medications.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking. Be sure to mention either of the following: anticoagulants (‘blood thinners’) such as warfarin (Coumadin); and triazolam (Halcion). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have or have ever had porphyria, phenylketonuria, or kidney or liver disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking Zantac (Ranitidine), call your doctor.
• Using Zantac may increase your risk of developing pneumonia. Symptoms of pneumonia include chest pain, fever, feeling short of breath, and coughing up green or yellow mucus. Talk with your doctor about your specific risk of developing pneumonia.

How and when to take Zantac

It’s usual to take Zantac (Ranitidine) twice a day – 1 dose in the morning and 1 dose in the evening. Some people only need to take Zantac (Ranitidine) once a day, at bedtime.

Very young babies, and people with Zollinger-Ellison syndrome, usually take Zantac (Ranitidine) 3 times a day. People with severe inflammation of the food pipe (esophagitis) may need to take it 4 times a day.

How to take Zantac

Take Zantac exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Your doctor may recommend an antacid to help relieve pain. Carefully follow your doctor’s directions about the type of antacid to use, and when to use it.

You can take Zantac (Ranitidine) with or without food. However, if you get symptoms whenever you eat or drink, take your medicine 30 minutes to 60 minutes before having a drink, snack or meal.

• Tablets – swallow tablets whole with a glass of water, milk or juice.
• Soluble tablets – dissolve tablets in half a glass of water. Do not use milk, fizzy water or other fizzy drinks. Wait until the medicine has completely dissolved and then drink it straight away.
• Liquid – this comes with a syringe or spoon to help you measure it. If you don’t have a syringe or spoon, ask your pharmacist for one. Do not use a kitchen teaspoon as it won’t give you the right amount.

Liquid Zantac (Ranitidine) is suitable for children and people who find it difficult to swallow tablets.

Do not crush, chew, or break the Zantac effervescent tablet, and do not allow it to dissolve on your tongue. The 25-milligram effervescent tablet must be dissolved in at least 1 teaspoon of water before swallowing. The150-milligram effervescent tablet should be dissolved in 6 to 8 ounces of water.

Allow the Zantac effervescent tablet to dissolve completely in the water, and then drink the entire mixture. If you are giving this medicine to a child, you may draw the liquid mixture into a medicine dropper and empty the dropper into the child’s mouth.

Zantac granules should be mixed with 6 to 8 ounces of water before drinking.

Measure Zantac liquid with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

It may take up to 8 weeks before your ulcer heals. Keep using the medication as directed and tell your doctor if your symptoms do not improve after 6 weeks of treatment.

This medication can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using Zantac.

Store Zantac at room temperature away from moisture, heat, and light.

How much Zantac will I take?

Each tablet contains 75mg, 150mg or 300mg of Zantac (Ranitidine). You can buy 75mg tablets in pharmacies and supermarkets. Soluble tablets, and 150mg and 300mg tablets are only available on prescription.

The usual dose to treat:

• indigestion or heartburn is 75mg to 300mg a day
• stomach ulcers and inflammation of the food pipe is 300mg to 600mg a day
• Zollinger-Ellison syndrome is 450mg to 6 grams a day

Zantac (Ranitidine) liquid comes in 2 different strengths – your daily dose will depend on what your doctor prescribes. Follow your doctor’s advice about how much Zantac (Ranitidine) to take and when.

• Doses are usually lower for children and people with kidney problems.

If a doctor prescribes Zantac (Ranitidine) for your child, they will use your child’s weight or age to work out the right dose.

Zantac Dosage

Active Duodenal Ulcer:

The current recommended adult oral dosage of Zantac for duodenal ulcer is 150 mg twice daily. An alternative dosage of 300 mg once daily after the evening meal or at bedtime can be used for patients in whom dosing convenience is important. The advantages of one treatment regimen compared with the other in a particular patient population have yet to be demonstrated. Smaller doses have been shown to be equally effective in inhibiting gastric acid secretion in US trials, and several foreign trials have shown that 100 mg twice daily is as effective as the 150-mg dose.

Antacid should be given as needed for relief of pain.

Maintenance of Healing of Duodenal Ulcers:

The current recommended adult oral dosage is 150 mg at bedtime.

Pathological Hypersecretory Conditions (such as Zollinger-Ellison syndrome):

The current recommended adult oral dosage is 150 mg twice daily. In some patients it may be necessary to administer Zantac 150-mg doses more frequently. Dosages should be adjusted to individual patient needs, and should continue as long as clinically indicated. Dosages up to 6 g/day have been employed in patients with severe disease.

Benign Gastric Ulcer:

The current recommended adult oral dosage is 150 mg twice daily.

Maintenance of Healing of Gastric Ulcers:

The current recommended adult oral dosage is 150 mg at bedtime.

Gastro-esophageal reflux disease (GERD):

The current recommended adult oral dosage is 150 mg twice daily.

Erosive Esophagitis:

The current recommended adult oral dosage is 150 mg 4 times daily.

Maintenance of Healing of Erosive Esophagitis:

The current recommended adult oral dosage is 150 mg twice daily.

Pediatric Use:

The safety and effectiveness of Zantac have been established in the age-group of 1 month to 16 years. There is insufficient information about the pharmacokinetics of Zantac in neonatal patients (aged younger than 1 month) to make dosing recommendations.

The following 3 subsections provide dosing information for each of the pediatric indications.

• Treatment of Duodenal and Gastric Ulcers: The recommended oral dose for the treatment of active duodenal and gastric ulcers is 2 to 4 mg/kg twice daily to a maximum of 300 mg/day. This recommendation is derived from adult clinical trials and pharmacokinetic data in pediatric patients.
• Maintenance of Healing of Duodenal and Gastric Ulcers: The recommended oral dose for the maintenance of healing of duodenal and gastric ulcers is 2 to 4 mg/kg once daily to a maximum of 150 mg/day. This recommendation is derived from adult clinical trials and pharmacokinetic data in pediatric patients.
• Treatment of GERD and Erosive Esophagitis: Although limited data exist for these conditions in pediatric patients, published literature supports a dosage of 5 to 10 mg/kg/day, usually given as 2 divided doses.

Dosage Adjustment for Patients with Impaired Renal Function:

On the basis of experience with a group of subjects with severely impaired renal function treated with Zantac, the recommended dosage in patients with a creatinine clearance <50 mL/min is 150 mg every 24 hours. Should the patient’s condition require, the frequency of dosing may be increased to every 12 hours or even further with caution. Hemodialysis reduces the level of circulating ranitidine. Ideally, the dosing schedule should be adjusted so that the timing of a scheduled dose coincides with the end of hemodialysis.

Elderly patients are more likely to have decreased renal function, therefore caution should be exercised in dose selection, and it may be useful to monitor renal function.

Will my dose go up or down?

Sometimes your doctor will increase your dose of Zantac (Ranitidine) if it isn’t working well enough.

Depending on the reason you take Zantac (Ranitidine), you may take a higher dose to start with – usually for at least 1 month. After this, your doctor may recommend a lower dose.

What if I forget to take Zantac?

If you usually take it:

• once a day, take the missed dose as soon as you remember, unless it’s less than 12 hours until your next dose – in which case skip the missed dose
• twice a day, take the missed dose as soon as you remember, unless it’s nearly time for your next dose – in which case skip the missed dose
• 3 or 4 times a day, skip the missed dose and take your next dose as normal

Do NOT take a double dose to make up for a forgotten dose.

If you often forget doses, it may help to set an alarm to remind you. You could also ask your pharmacist for advice on other ways to remember your medicine.

What if I take too much Zantac?

Zantac (Ranitidine) is generally very safe. Taking too much is unlikely to harm you or your child.

If you take an extra dose by mistake, you might get some side effects, such as feeling sick. Call your doctor if you’re worried, or you’re bothered by side effects.

Zantac dosage

Zantac 75

Active ingredient (in each tablet): Ranitidine 75 mg (as ranitidine hydrochloride 84 mg)

Inactive ingredients: hypromellose, magnesium stearate, microcrystalline cellulose, synthetic red iron oxide, titanium dioxide, triacetin

Other information

• Blister: do not use if individual blister unit is open or torn
• Bottle: do not use if printed foil under bottle cap is open or torn
• store at 20°-25°C (68°-77°F)
• avoid excessive heat or humidity
• this product is sodium and sugar free

Zantac 75 Uses

• relieves heartburn associated with acid indigestion and sour stomach
• prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain foods and beverages

Zantac 75 Directions of Use

• Adults and children 12 years and over:
  • to relieve symptoms, swallow 1 tablet whole with a glass of water. The tablet must NOT be chewed or crushed.
  • to prevent symptoms, swallow 1 tablet whole with a glass of water 30 to 60 minutes before eating food or drinking beverages that cause heartburn. The tablet must NOT be chewed or crushed.
  • can be used up to twice daily (do not take more than 2 tablets in 24 hours)
• Children under 12 years: ask a doctor

Zantac 75 can be taken 30 to 60 minutes before eating food or drinking beverages that cause heartburn to prevent symptoms, or it can be taken when heartburn symptoms strike, providing relief in as little as 30 minutes and lasting up to 12 hours.

You may take up to two (2) Zantac 75 tablets a day. Stop use and ask a doctor if you need to take this product for more than 14 days.

Zantac 75 Warnings

Allergy alert

• Do NOT use if you are allergic to ranitidine or other acid reducers

Do NOT use:

• if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor.
  with other acid reducers

Ask a doctor before use if you have:

• had heartburn over 3 months. This may be a sign of a more serious condition.
• heartburn with lightheadedness, sweating or dizziness
• chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness
• frequent chest pain
• frequent wheezing, particularly with heartburn
• unexplained weight loss
• nausea or vomiting
• stomach pain

Stop use and ask a doctor if:

• your heartburn continues or worsens
• you need to take this product for more than 14 days

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Maximum Strength Zantac 150

Active ingredient (in each tablet): Ranitidine 150 mg (as ranitidine hydrochloride 168 mg)

Inactive ingredients: hypromellose, magnesium stearate, microcrystalline cellulose, synthetic red iron oxide, titanium dioxide, triacetin

Other information

• Blister: do not use if individual blister unit is open or torn
• Bottle: do not use if printed foil under bottle cap is open or torn
• store at 20°-25°C (68°-77°F)
• avoid excessive heat or humidity
• this product is sodium and sugar free

Maximum Strength Zantac 150 Uses

• relieves heartburn associated with acid indigestion and sour stomach
• prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain foods and beverages

Maximum Strength Zantac 150 Directions of Use

• Adults and children 12 years and over:
  • to relieve symptoms, swallow 1 tablet whole with a glass of water. The tablet must NOT be chewed or crushed.
  • to prevent symptoms, swallow 1 tablet whole with a glass of water 30 to 60 minutes before eating food or drinking beverages that cause heartburn. The tablet must NOT be chewed or crushed.
  • can be used up to twice daily (do not take more than 2 tablets in 24 hours)
• Children under 12 years: ask a doctor

Zantac 75 can be taken 30 to 60 minutes before eating food or drinking beverages that cause heartburn to prevent symptoms, or it can be taken when heartburn symptoms strike, providing relief in as little as 30 minutes and lasting up to 12 hours.

You may take up to two (2) Zantac 75 tablets a day. Stop use and ask a doctor if you need to take this product for more than 14 days.

Maximum Strength Zantac 150 Warnings

Allergy alert

• Do NOT use if you are allergic to ranitidine or other acid reducers

Do NOT use:

• if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor.
  with other acid reducers

Ask a doctor before use if you have:

• had heartburn over 3 months. This may be a sign of a more serious condition.
• heartburn with lightheadedness, sweating or dizziness
• chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness
• frequent chest pain
• frequent wheezing, particularly with heartburn
• unexplained weight loss
• nausea or vomiting
• stomach pain

Stop use and ask a doctor if:

• your heartburn continues or worsens
• you need to take this product for more than 14 days

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Zantac side effects

Most people who take Zantac (Ranitidine) do not have any side effects. If you do get a side effect, it is usually mild and will go away when you stop taking Zantac (Ranitidine).

The following side effects aren’t common and may happen in more than 1 in 1,000 people. Talk to your doctor or pharmacist if these side effects bother you or don’t go away:

• stomach pains
• constipation
• feeling sick (nausea)
• headache
• diarrhea
• vomiting

Zantac (Ranitidine) may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

These are not all the side effects of Zantac (Ranitidine). For a full list see the leaflet inside your medicines packet.

The following have been reported as events in clinical trials or in the routine management of patients treated with Zantac. The relationship to therapy with Zantac has been unclear in many cases. Headache, sometimes severe, seems to be related to administration of Zantac.

Central Nervous System

Rarely, malaise, dizziness, somnolence, insomnia, and vertigo. Rare cases of reversible mental confusion, agitation, depression, and hallucinations have been reported, predominantly in severely ill elderly patients. Rare cases of reversible blurred vision suggestive of a change in accommodation have been reported. Rare reports of reversible involuntary motor disturbances have been received.

Cardiovascular

As with other H2-blockers, rare reports of arrhythmias such as tachycardia, bradycardia, atrioventricular block, and premature ventricular beats.

Gastrointestinal

Constipation, diarrhea, nausea/vomiting, abdominal discomfort/pain, and rare reports of pancreatitis.

Hepatic

There have been occasional reports of hepatocellular, cholestatic, or mixed hepatitis, with or without jaundice. In such circumstances, Zantac (Ranitidine) should be immediately discontinued. These events are usually reversible, but in rare circumstances death has occurred. Rare cases of hepatic failure have also been reported. In normal volunteers, SGPT values were increased to at least twice the pretreatment levels in 6 of 12 subjects receiving 100 mg intravenously 4 times daily for 7 days, and in 4 of 24 subjects receiving 50 mg intravenously 4 times daily for 5 days.

Musculoskeletal

Rare reports of arthralgias and myalgias.

Hematologic

Blood count changes (leukopenia, granulocytopenia, and thrombocytopenia) have occurred in a few patients. These were usually reversible. Rare cases of agranulocytosis, pancytopenia, sometimes with marrow hypoplasia, and aplastic anemia and exceedingly rare cases of acquired immune hemolytic anemia have been reported.

Endocrine

Controlled studies in animals and man have shown no stimulation of any pituitary hormone by Zantac and no antiandrogenic activity, and cimetidine-induced gynecomastia and impotence in hypersecretory patients have resolved when Zantac has been substituted. However, occasional cases of impotence and loss of libido have been reported in male patients receiving Zantac, but the incidence did not differ from that in the general population. Rare cases of breast symptoms and conditions, including galactorrhea and gynecomastia, have been reported in both males and females.

Integumentary

Rash, including rare cases of erythema multiforme. Rare cases of alopecia and vasculitis.

Respiratory

A large epidemiological study suggested an increased risk of developing pneumonia in current users of histamine-2-receptor antagonists (H2RAs) compared with patients who had stopped H2RA treatment, with an observed adjusted relative risk of 1.63 (95% CI: 1.07–2.48). However, a causal relationship between use of H2RAs and pneumonia has not been established.

Other

Rare cases of hypersensitivity reactions (e.g., bronchospasm, fever, rash, eosinophilia), anaphylaxis, angioneurotic edema, acute interstitial nephritis, and small increases in serum creatinine.

Serious side effects

Serious side effects are very rare and happen in less than 1 in 10,000 people. Call a doctor straight away if you have:

• stomach pain that seems to be getting worse – this can be a sign of an inflamed liver or pancreas
• back pain, fever, pain when peeing or blood in your pee – these can be signs of kidney problems
• a rash, swollen joints or kidney problems – these can be signs that your small blood vessels are swollen (vasculitis)
• a slow or irregular heartbeat

Serious allergic reaction

In rare cases, it’s possible to have a serious allergic reaction to Zantac (Ranitidine).

• A serious allergic reaction is an emergency. Contact a doctor straight away if you think you or someone around you is having a serious allergic reaction.

The warning signs of a serious allergic reaction are:

• getting a skin rash that may include itchy, red, swollen, blistered or peeling skin
• wheezing
• tightness in the chest or throat
• having trouble breathing or talking
• swelling of the mouth, face, lips, tongue or throat

How to cope with side effects

What to do about:

• stomach pains – try to rest and relax. It can help to eat and drink slowly and have smaller and more frequent meals. Putting a heat pad or covered hot water bottle on your tummy may also help. If you are in a lot of pain, speak to your pharmacist or doctor.
• constipation – eat more high-fiber foods such as fresh fruit and vegetables and cereals, and drink plenty of water. Try to exercise more regularly, for example, by going for a daily walk or run. If this doesn’t help, talk to your pharmacist or doctor.
• feeling sick – it may help if you don’t eat rich or spicy food while you’re taking Zantac (Ranitidine).

Human Toxicity Reports

Headache (sometimes severe) occurs in approx 3% of patients receiving the drug ². Malaise, dizziness, somnolence, insomnia, and vertigo have been reported less frequently. Reversible mental confusion, agitation, mental depression, and hallucinations have occurred, mainly in debilitated geriatric patients. A child who was receiving prolonged, high-dose oral ranitidine therapy (8 mg/kg once daily for 10 months) developed altered consciousness, drowsiness, dysarthria, hyporeflexia, positive Babinski’s sign, diaphoresis, and bradycardia, which resolved within 24 hr after discontinuance of the drug.

Constipation, nausea, vomiting, and abdominal discomfort or pain have occurred in patients receiving ranitidine. Pancreatitis has been reported rarely ².

Rash, which may be urticarial, maculopapular, and/or pruritic, has been reported during ranitidine therapy ². Rash suggestive of mild erythema multiforme has occurred rarely. Urticaria at the site of injection has occurred following IV admin of ranitidine. Alopecia has occurred rarely ².

Leukopenia, granulocytopenia, agranulocytosis, thrombocytopenia, aplastic anemia, acquired immune hemolytic anemia, and pancytopenia, which may be accompanied by bone marrow hypoplasia, have been reported rarely in patients receiving ranitidine ². Alterations in blood cell counts usually were reversible. At least one case of leukocytosis has been reported 6-8 days after initiating ranitidine therapy, which resolved following discontinuance ². Aplastic anemia has occurred in at least one patient receiving ranitidine ².

Small increases in serum creatinine, without concomitant increases in BUN, have been reported during ranitidine therapy ². Increases in serum aminotransferase, alkaline phosphatase, LDH, total bilirubin, and gamma-glutamyl transferase concentration have been reported and reversible hepatitis, which may be hepatocellular, hepatocanalicular, or both and may or may not be accompanied by jaundice, has occurred occasionally in individuals receiving ranitidine and usually was reversible; however, death has been reported rarely ².

A 63 yr old woman developed anicteric hepatitis after two wk of therapy with ranitidine ³. Despite continuation of therapy, her symptoms resolved within 5 days and transaminase levels returned to normal in the next 4 weeks, at which time use of the drug ceased. No other cause for the reaction could be found ³.

Cardiac arrhythmias have occurred rarely in patients receiving ranitidine ². Bradycardia, sometimes assoc with dyspnea, has occurred ². Tachycardia, AV block, asystole, and ventricular premature complexes have also been reported rarely ².

Arthralgias, myalgias, and hypersensitivity reactions such as bronchospasm, fever, rash, and eosinophilia have occurred rarely in patients receiving ranitidine ². Anaphylaxis, characterized by severe urticaria and a decrease in blood pressure in one patient following administration of a single dose of ranitidine, has occurred rarely; exacerbation of asthma and angioedema also has occurred ². Mild erythema multiforme-like rash and alopecia also have occurred rarely. Rare reports suggest that ranitidine may precipitate acute attacks of porphyria in patients with acute porphyria; therefore, the drug should be avoided in patients with a history of acute porphyria ².

In a study of 51 male patients with duodenal ulcer, treatment with ranitidine, produced no decrease in basal levels of serum testosterone, as did cimetidine ⁴.

Ranitidine inhibited in a dose-dependent manner acetylcholinesterases from human erythrocytes and gastric mucosa ⁵. Pseudocholinesterase in serum was also inhibited, the levels required were about 25 times higher. A stimulation of cholinergic mechanisms in ranitidine treatment should occur, e.g, stimulation of glandular secretion or increase of gastrointestinal motility ⁵.

Symptoms of acute intoxication with both cimetidine and ranitidine are bradycardia and tachycardia ⁶; CNS disturbances, including confusion, delirium, drowsiness, slurred speech, flushing, and sweating; dermatologic lesions; endocrine abnormalities; GI disorders; and liver dysfunction ⁶.

Most controlled studies in humans indicate that ranitidine does not alter theophylline metabolism, even at high doses ⁷. However, there have been several case reports published recently which demonstrate the development of theophylline toxicity mostly in older patients receiving stable oral doses of this drug when ranitidine was administered simultaneously ⁷. A study involving eleven elderly (mean age, 69.0 + or – 6.2 years) patients with chronic obstructive pulmonary disease (COPD). During one week the patients took slow-release theophylline, 200 mg every 12 hr, followed by one week intake of the same dose of theophylline plus ranitidine tablets, 150 mg every 12 hr. At the end of each period, blood samples were obtained 0, 1, 2, 3, 4, 5, 6, 7, 8 and 12 hr after the morning dose for the determination of serum theophylline levels. The peak theophylline concentration (Tmax) was achieved after 4.1 + or – 0.9 hr while the patients were taking theophylline, and after 2.9 + or – 1.4 hr with the combined regimen. This difference was statistically significant. In only 3/11 subjects did Tmax remain unchanged during both phases of the study. The mean theophylline clearance rates while the patients were receiving theophylline alone (39.58 + or – 19.89 ml/min) and when they were receiving both medications 134.42 + or – 10.55 ml/min) were similar. The mean serum levels while the patients were receiving theophylline alone were slightly higher but not statistically different. These results suggest that the reported increases in serum theophylline levels in older patients receiving theophylline and ranitidine cannot be ascribed to slower theophylline metabolism in the geriatric patients with chronic obstructive pulmonary disease who is also given ranitidine ⁷.

A case report of acute cholestatic hepatitis associated with rash and hypereosinophilia, in which the absence of transfusion, intercurrent viral infection, alcohol consumption or other hepatotoxic drugs are suggestive of ranitidine-induced hepatotoxicity ⁸. The pathogenesis of the disorder is unknown, but the lack of a dose-effect relationship, the rarity and unpredictability of the reaction, as well as the clinical signs suggest that hypersensitivity is involved. Physicians should be aware of this rare and idiosyncratic side-effect of ranitidine ⁸.

Although acute interstitial nephritis has been well described with the histamine H2-receptor antagonist cimetidine, a study authors found only one previous case report of ranitidine-induced interstitial nephritis in the literature ⁹. They describe an additional patient who developed acute interstitial nephritis after taking ranitidine ⁹. Electron microscopy showed focal fusion of the epithelial cell foot processes that was not described in the previous report of ranitidine-induced interstitial nephritis.

Reversible hematologic abnormalities including hemolytic anemia ¹⁰ with a positive direct Coombs’ test have been associated with ranitidine. In addition to the case report cited above, the US Food and Drug Administration had received five other cases of hemolysis associated with recent intake of ranitidine as of February 1991 ¹⁰. To investigate the possible association of ranitidine with autoimmune hemolytic anemia, a study was conducted to determine how often diagnoses of hemolytic anemia or abnormal Coombs’ test results followed dispensing of ranitidine using the automated medical and pharmacy records of a large health maintenance organization. No occurrences of hemolytic anemia were identified among 12,054 individuals following 38,686 prescriptions for this medication. The 95% upper confidence bound was 3.1 cases/10,000 exposed persons. One abnormal direct Coombs test with mild anemia was discovered during routine prenatal testing of an asymptomatic patient who was dispensed ranitidine two and a half months previously. Hemolysis, however, was not demonstrated and an association with prior ranitidine use could not be confirmed. Additional analyses indicate that in only 30% of ranitidine courses was a blood count obtained. In those courses with hematocrits below 40%, less than 1% had a Coombs’ test performed. Chart review suggests that the majority of individuals with severe anemia have alternative explanations other than autoimmune hemolysis for their anemia ¹⁰. This analysis indicates that ranitidine is unlikely to be a common cause of clinically recognized autoimmune hemolytic anemia and demonstrates the utility of large automated medical and pharmacy data bases to conduct post-marketing studies of spontaneously reported drug effects.

Zantac overdose

Zantac (Ranitidine) overdose occurs when someone takes more than the normal or recommended amount of this medicine. This can be by accident or on purpose.

There has been limited experience with overdosage. Reported acute ingestions of up to 18 g orally have been associated with transient adverse effects similar to those encountered in normal clinical experience. In addition, abnormalities of gait and hypotension have been reported.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. This is a free and confidential service. All local poison control centers in the United States use this national number. You should call if you have any questions about poisoning or poison prevention. It does NOT need to be an emergency. You can call for any reason, 24 hours a day, 7 days a week.

Symptoms of an Zantac (Ranitidine) overdose are:

• Abnormal heartbeat, including rapid or slow heartbeat
• Drowsiness, confusion
• Diarrhea
• Difficulty breathing
• Dilated pupils
• Flushing
• Low blood pressure
• Nausea, vomiting
• Slurred speech
• Sweating

Seek medical help right away. DO NOT make the person throw up unless poison control or a health care provider tells you to.

When overdosage occurs, the usual measures to remove unabsorbed material from the gastrointestinal tract, clinical monitoring, and supportive therapy should be employed.

Studies in dogs receiving dosages of Zantac in excess of 225 mg/kg/day have shown muscular tremors, vomiting, and rapid respiration. Single oral doses of 1,000 mg/kg in mice and rats were not lethal. Intravenous LD50 values in mice and rats were 77 and 83 mg/kg, respectively.

What to Expect at the Emergency Room

Take the container with you to the hospital, if possible.

The provider will measure and monitor the person’s vital signs, including temperature, pulse, breathing rate, and blood pressure. Symptoms will be treated. The person may receive:

• Activated charcoal
• Blood and urine tests
• Breathing support, including oxygen
• Chest x-ray
• ECG (electrocardiogram, or heart tracing)
• Intravenous fluids (through a vein)
• A laxative
• Medicine to treat symptoms
• Tube through the mouth into the stomach to empty the stomach (gastric lavage)

Outlook (Prognosis)

Serious complications are rare. These are generally safe medicines, even when taken in large doses.

References

1. McEvoy G.K. (ed.). American Hospital Formulary Service-Drug Information 96. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 1996 (Plus Supplements)., p. 2184
2. McEvoy G.K. (ed.). American Hospital Formulary Service-Drug Information 96. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 1996 (Plus Supplements)., p. 2182
3. Barr GD, Piper DW; Med J Aust 2 (8): 421; 1981 https://www.ncbi.nlm.nih.gov/pubmed/6275248
4. Peden NR et al; Acta Endocrinol (Copenh) 96 (4): 564-8;1981 http://www.eje-online.org/content/96/4/564.long
5. Hansen WE, Bertl S; Z Gastroenterol 21 (4): 164-7;1983 https://www.ncbi.nlm.nih.gov/pubmed/6306938
6. Haddad, L.M., Clinical Management of Poisoning and Drug Overdose. 2nd ed. Philadelphia, PA: W.B. Saunders Co., 1990., p. 824
7. Cukier A et al; Braz J Med Biol Res 28 (8): 875-9;1995 https://www.ncbi.nlm.nih.gov/pubmed/8555989
8. Devuyst C et al; Acta Clin Belg 48 (2): 109-14;1993 https://www.ncbi.nlm.nih.gov/pubmed/8392242
9. Gaughan WJ et al; Am J Kidney Dis 22 (2): 337-40;1993 https://www.ncbi.nlm.nih.gov/pubmed/8352263
10. Choo PW et al; J Clin Epidemiol 47 (lO): 1175-9; 1994 ttps://www.ncbi.nlm.nih.gov/pubmed/7722551

What is Claritin

Claritin is an antihistamine medicine that relieves the symptoms of allergies. Claritin contain an active ingredient called Loratadine, which is known as a non-drowsy antihistamine (a second generation antihistamine). Claritin (Loratadine) is much less likely to make you feel sleepy than some other antihistamines. Claritin (Loratadine) is a histamine [H1] receptor blocker, it works by blocking the action of histamine, a substance in the body that causes allergic symptoms. When you come into contact with something you have an allergy to, such as pollen, animal hair or fur, house dust or insect bites, your body produces a chemical called histamine. Histamine is a chemical that’s released by Mast cells in your body when an allergen is encountered that can produce symptoms of sneezing, hives, itching, watery eyes, and runny nose, also known as hypersensitivity reactions. Usually histamine is a useful substance but in an allergic reaction it causes unpleasant symptoms including itchy, watery eyes, running or blocked nose, sneezing and skin rashes. Claritin (Loratadine) blocks the effects of histamine and so reduces these symptoms.

Claritin (Loratadine) is used to treat hay fever, allergic conjunctivitis (red, itchy eye), eczema and hives. Claritin (Loratadine) is also used for reactions to insect bites and stings and for some food allergies.

What’s the difference between Claritin (Loratadine) and other antihistamines?

Claritin (Loratadine) is known as a non-drowsy antihistamine. It’s less likely to make you feel sleepy than other, so-called sedating antihistamines such as Piriton (chlorphenamine).

Most people prefer to take a non-drowsy antihistamine instead of a sedating one. An exception is when you want the medicine to make you sleepy because you’ve got itchy skin that’s keeping you awake.

What’s the difference between Claritin (Loratadine) and other non-drowsy antihistamines?

Other non-drowsy antihistamines like cetirizine (Zyrtec), desloratadine, fexofenadine, levocetirizine seem to work as well as Claritin (Loratadine).

However, Claritin (Loratadine), desloratadine and fexofenadine seem to be less likely to make you feel sleepy than cetirizine (Zyrtec).

What is Claritin used for

Claritin (Loratadine) is often used to temporarily relieve the symptoms of hay fever (allergy to pollen, dust, or other substances in the air) and other allergies. These symptoms include sneezing, runny nose, and itchy eyes, nose, or throat. Claritin (Loratadine) is also used to treat itching and redness caused by hives. However, Claritin (Loratadine) does not prevent hives or other allergic skin reactions.

Claritin (Loratadine) is also available in combination with pseudoephedrine (Sudafed, others). This monograph only includes information about the use of Claritin (Loratadine) alone. If you are taking the Claritin (Loratadine) and pseudoephedrine combination product, read the information on the package label or ask your doctor or pharmacist for more information.

Loratadine is available on prescription. You can also buy Claritin (Loratadine) from pharmacies and supermarkets.

Claritin (Loratadine) comes as tablets or as a liquid that you swallow.

Claritin (Loratadine), a new nonsedating antihistamine, was evaluated for efficacy and safety in 228 patients with perennial allergic rhinitis. Taken at a dose of 10 mg once daily, Claritin (Loratadine) was significantly more effective than placebo and comparable to terfenadine, 60 mg taken twice daily, in reducing combined symptom scores in this patient population. Efficacy was maintained throughout the 28 day course of treatment ¹. The overall incidence of side effects with Claritin (Loratadine) was low (14%) with few occurrences of sedation (3%) and dry mouth (4%).

Key facts

• It’s usual to take Claritin (Loratadine) once a day.
• Claritin (Loratadine) is classed as a non-drowsy antihistamine, but some people still find it makes them feel slightly sleepy.
• Children may also have a headache and feel tired or nervous after taking Claritin (Loratadine).
• It’s best NOT to drink alcohol while you’re taking Claritin (Loratadine) as it can make you feel sleepy.
• Loratadine is also called by the brand names Clarityn Allergy, Clarityn Rapide Allergy, Alavert, Claritin, Claritin Reditab, Clear-Atadine, Dimetapp ND, ohm Allergy Relief, QlearQuil All Day & Night, Tavist ND, Wal-itin.

When will I feel better?

You should start to feel better within an hour.

How long should I take Claritin for?

It depends on why you’re taking it.

You may only need to take Claritin (Loratadine) for a short time or as a one-off dose. If you have a reaction to an insect bite, you may only need to take Claritin (Loratadine) for a day or 2.

You may need to take it for longer if you’re taking it to prevent symptoms from hay fever when the pollen count is high.

Talk to your doctor or pharmacist if you’re unsure how long you need to take Claritin (Loratadine) for.

Is it safe to take Claritin for a long time?

Claritin (Loratadine) is unlikely to do you any harm if you take it for a long time. However, it’s best to take Claritin (Loratadine) only for as long as you need to.

Can I take more than one antihistamine together?

Sometimes doctors recommend that people with severe itchy skin rash take 2 different antihistamines together for a few days.

As well as taking a non-drowsy antihistamine like Claritin (Loratadine) during the day, your doctor may tell you to take a sedating antihistamine (e.g. Benadryl) at night if the itch is making it difficult to sleep.

Do not take 2 antihistamines together unless recommended by your doctor.

Can I take Claritin at higher doses than on the packet?

Your doctor might suggest you or your child take a higher dose of Claritin (Loratadine) (up to 4 times the usual dose) for severe itchy skin rash or angioedema (swelling underneath the skin).

Taking high doses of Claritin (Loratadine) isn’t suitable for everyone though. Speak to your doctor if you think Claritin (Loratadine) isn’t working for you.

Can I take Claritin with other hay fever treatments?

Yes, it’s fine to take Claritin (Loratadine) together with other hay fever treatments, for example steroid nasal sprays (such as Beconase, Rhinacort Aqua and Flixonase Nasules) or eye drops.

Can I take Claritin with painkillers?

Yes, you can take Claritin (Loratadine) together with acetaminophen (Tylenol) or ibuprofen (Motrin or Advil).

Is there any food or drinks I need to avoid?

You can eat and drink normally while taking loratadine.

Can I drive or ride a bike with it?

Claritin (Loratadine) is classed as a non-drowsy antihistamine but it’s still possible to feel sleepy after taking it.

If this happens to you, don’t drive a car or ride a bike until you feel better.

Can lifestyle changes relieve hay fever?

It will help if you don’t spend too much time outside if the pollen count is high. Also:

Tips for when you’re outside:

• Don’t cut grass or walk on grass.
• Wear wraparound sunglasses to stop pollen getting into your eyes.
• Put Vaseline around your nostrils to help trap pollen.
• Shower and change your clothes after you’ve been outside to wash off pollen.

Tips for when you’re inside:

• Keep windows and doors shut as much as possible.
• Vacuum regularly and dust with a damp cloth.
• Don’t keep fresh flowers in the house.
• Don’t smoke or be around smoke as it makes hay fever symptoms worse.

Claritin and alcohol

It’s best not to drink alcohol while you’re taking Claritin (Loratadine), as it can make you feel sleepy, drowsy and dizzy and increased your risk for Claritin overdose

Who can and can’t take Claritin

Claritin (Loratadine) can be taken by adults and children aged 2 years and older.

Claritin (Loratadine) isn’t suitable for some people. Tell your doctor or pharmacist if you:

• have had an allergy to Claritin (Loratadine) or any other medicines in the past
• have severe liver failure
• have an intolerance to, or cannot absorb, some sugars such as lactose or sucrose
• have epilepsy or another illness that puts you at risk of fits
• have a rare illness called porphyria
• are booked to have an allergy test – taking Claritin (Loratadine) may affect the results so you might need to stop taking it a few days before the test

Cautions with other medicines

Some medicines and Claritin (Loratadine) interfere with each other and increase the chances of you having side effects.

Tell your doctor if you’re taking:

• amiodarone, a medicine used to treat an irregular heart beat
• cimetidine, an indigestion medicine
• erythromycin, an antibiotic
• ketoconazole, a medicine to treat fungal infections
• midodrine, a medicine used to treat low blood pressure
• ritonavir, a medicine used to treat HIV infection
• any medicine that makes you feel sleepy, gives you a dry mouth or makes it difficult for you to pee. Taking Claritin (Loratadine) might make these side effects worse.

Tell your doctor or pharmacist if you’re taking any other medicines, including herbal remedies, vitamins or supplements.

Mixing Claritin (Loratadine) with herbal remedies and supplements

There might be a problem taking some herbal remedies and supplements alongside Claritin (Loratadine) – especially ones that cause sleepiness, a dry mouth or make it difficult to pee.

Ask your pharmacist for advice.

Pregnancy and breastfeeding

It’s generally safe to take Claritin (Loratadine) during pregnancy and while breastfeeding.

Can taking Claritin during pregnancy cause birth defects?

It is unlikely that Claritin (Loratadine) would cause an increased chance for birth defects. One study with several limitations suggested a small risk for hypospadias (a condition where the opening of the penis is on the underside of the penis instead of at the tip). After collecting more data, this study author published another paper that admitted the increased risk originally seen may have been due to study limitation. In addition, additional studies of pregnant women taking Claritin (Loratadine) have not supported an increased risk of any type of birth defect, including hypospadias. Also, studies involving infants with hypospadias did not find that their mothers used Claritin (Loratadine) more frequently during pregnancy.

Can taking Claritin cause other pregnancy problems?

Claritin (Loratadine) is not expected to cause other pregnancy problems. A study of 161 women taking Claritin (Loratadine) during the first trimester did not show any differences in the rates of delivery age, or birthweight compared to women who did not take Claritin (Loratadine) .

I just found out that I am pregnant. Should I stop taking Claritin?

You should always speak with your healthcare provider before making any changes in your medication. It is important to consider the benefits of treating allergy symptoms during pregnancy. Treating allergy symptoms may help reduce asthma symptoms and sinus problems. This can prevent the need for extra medications. Allergy treatment may also lead to better sleep and emotional well-being.

Does taking Claritin during my pregnancy increase the chance of miscarriage?

Probably not. A study of 161 women taking Claritin (Loratadine) during the first trimester did not show any differences in the rates of miscarriage.

Can Claritin make it harder for me to get pregnant?

One animal study did not report fertility issues in females exposed to Claritin (Loratadine). There are no other studies available.

Will Claritin affect my fertility?

There’s no evidence that Claritin (Loratadine) affects male or female fertility.

Will Claritin affect my contraception?

For women, Claritin (Loratadine) will not affect contraceptive pills or the morning after pill.

Claritin and breastfeeding

If you’re breastfeeding and your baby was premature or has other health problems, talk to your doctor before taking Claritin (Loratadine).

Studies estimate that a breastfeeding baby whose mother is taking Claritin (Loratadine) would get less than 1% of the mother’s dose. This dose of Claritin (Loratadine) is thought to be too low to cause problems for the baby. Compared to some other antihistamines, Claritin (Loratadine) has less chance of causing drowsiness for the mother or the baby. This, along with the low levels in milk, makes Claritin (Loratadine) one of the preferred antihistamines for use during breastfeeding. Be sure to talk to your healthcare provider about all of your breastfeeding questions.

Because of its lack of sedation and low milk levels, maternal use of Claritin (Loratadine) would not be expected to cause any adverse effects in breastfed infants ². Claritin (Loratadine) might have a negative effect on lactation, especially in combination with a sympathomimetic agent such as pseudoephedrine. The British Society for Allergy and Clinical Immunology recommends Claritin (Loratadine) at its lowest dose as a preferred choice if an antihistamine is required during breastfeeding ².

After a single oral dose of 40 mg of Claritin (Loratadine) in 6 women, average peak milk levels of 29.2 (range 20.4 to 39) mcg/L occurred at two hours after the dose ³. In addition, average desloratadine peak milk levels of 16 (range 9 to 29.6) mcg/L occurred at 5.3 hours after the dose. The total amount excreted in milk over 48 hours was 11.7 mcg of Claritin (Loratadine) and its metabolite. However, the dose administered was four times greater than the usual dose of the drug, so a total dose of about 3 mcg would be expected with a 10 mg dose. The calculated average and maximum expected doses of Claritin (Loratadine) plus desloratadine in milk were 0.46 and 1.1% and of the maternal weight-adjusted dose, respectively, after the 40 mg dose ³.

A survey of 51 mothers who took Claritin (Loratadine) during breastfeeding between 1999 and 2001 was conducted by a teratogen information service ⁴. Most of the infants were over 2 months old and Claritin (Loratadine) was generally taken for one week or less. Two mothers reported minor sedation in their infants, one at 3 days of age and one at 3 months of age. Both mothers were taking a dose of 10 mg daily. Weight gain and psychomotor development were similar to infants in a control group of breastfed infants unexposed to medications ⁵. An extension of the study that compared the results of this study (plus one additional patient) to that of a control group of 88 mothers who took a drug known to be safe while breastfeeding. No differences in sedation or any other side effects in the infant were found between mothers who took Claritin (Loratadine) during breastfeeding and those of the control group ⁴.

Effects on Lactation and Breastmilk

Antihistamines in relatively high doses given by injection can decrease basal serum prolactin in nonlactating women and in early postpartum women ⁶, ⁷. However, suckling-induced prolactin secretion is not affected by antihistamine pretreatment of postpartum mothers ⁶. Whether lower oral doses of antihistamines have the same effect on serum prolactin or whether the effects on prolactin have any consequences on breastfeeding success have not been studied. The prolactin level in a mother with established lactation may not affect her ability to breastfeed.

One mother out of 51 mothers who took Claritin (Loratadine) while nursing reported that she had decreased milk production after taking Claritin (Loratadine) 10 mg daily for less than one week at 4 months postpartum ⁵.

Claritin uses

Claritin (Loratadine) is used to temporarily relieve the symptoms of hay fever (allergy to pollen, dust, or other substances in the air) and other allergies. These symptoms include sneezing, runny nose, and itchy eyes, nose, or throat. Claritin (Loratadine) is also used to treat itching and redness caused by hives. However, Claritin (Loratadine) does not prevent hives or other allergic skin reactions. Claritin (Loratadine) is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms.

Claritin (Loratadine) is also available in combination with pseudoephedrine (Sudafed, others). This monograph only includes information about the use of Claritin (Loratadine) alone. If you are taking the Claritin (Loratadine) and pseudoephedrine combination product, read the information on the package label or ask your doctor or pharmacist for more information.

How should Claritin be used?

Claritin (Loratadine) comes as a syrup (liquid), an immediate acting and extended release tablet, and a rapidly disintegrating (dissolving) tablet to take by mouth. It is usually taken once a day with or without food. Follow the directions on the package label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take Claritin (Loratadine) exactly as directed. Do not take more or less of it or take it more often than directed on the package label or recommended by your doctor. If you take more Claritin (Loratadine) than directed, you may experience drowsiness.

If you are taking the rapidly disintegrating tablet, follow the package directions to remove the tablet from the blister package without breaking the tablet. Do not try to push the tablet through the foil. After you remove the tablet from the blister package, immediately place it on your tongue and close your mouth. The tablet will quickly dissolve and can be swallowed with or without water.

Do not use Claritin (Loratadine) to treat hives that are bruised or blistered, that are an unusual color, or that do not itch. Call your doctor if you have this type of hives.

Stop taking Claritin (Loratadine) and call your doctor if your hives do not improve during the first 3 days of your treatment or if your hives last longer than 6 weeks. If you do not know the cause of your hives, call your doctor.

If you are taking Claritin (Loratadine) to treat hives, and you develop any of the following symptoms, get emergency medical help right away: difficulty swallowing, speaking, or breathing; swelling in and around the mouth or swelling of the tongue; wheezing; drooling; dizziness; or loss of consciousness. These may be symptoms of a life-threatening allergic reaction called anaphylaxis. If your doctor suspects that you may experience anaphylaxis with your hives, he may prescribe an epinephrine injector (EpiPen). Do not use Claritin (Loratadine) in place of the epinephrine injector.

Do not use this medication if the safety seal is open or torn.

Before taking Claritin – Precautions

• tell your doctor and pharmacist if you are allergic to Claritin (Loratadine), any other medications, or any of the ingredients in the type of Claritin (Loratadine) you will be taking. Check the package label for a list of the ingredients.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements and herbal products you are taking or plan to take. Be sure to mention medications for colds and allergies.
• tell your doctor if you have or have ever had asthma or kidney or liver disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking Claritin (Loratadine), call your doctor.
• if you have phenylketonuria (PKU, an inherited condition in which a special diet must be followed to prevent mental retardation), you should know that some brands of the orally disintegrating tablets may contain aspartame that forms phenylalanine.

How and when to take Claritin

If you or your child have been prescribed Claritin (Loratadine), follow your doctor’s instructions about how and when to take it. If you’ve bought Claritin (Loratadine) from a pharmacy or shop, follow the instructions that come with the packet.

How much should I take?

Claritin (Loratadine) comes as 10mg tablets and as a liquid medicine (labelled either 5mg/ml or 1mg/1ml). You can take Claritin (Loratadine) with or without food.

The usual dose in adults is 10mg once a day.

Doses are usually lower for people with liver problems.

For children, your doctor will use your child’s weight or age to work out the right dose.

In studies with Claritin (Loratadine) tablets at doses 2 to 4 times higher than the recommended dose of 10 mg, a dose-related increase in the incidence of somnolence was observed. therefore, some patients, particularly those with hepatic or renal impairment and the elderly, may experience somnolence ⁸.

How to take it

Claritin (Loratadine) comes as 2 different types of tablet – ordinary and melt-in-the-mouth tablets.

Swallow ordinary Claritin (Loratadine) tablets with a drink of water, milk or juice. If the tablet has a score line, you can break it in half if you find it hard to swallow it whole. Do not chew it.

Melt-in-the-mouth tablets dissolve instantly on your tongue without needing a drink. Be careful not to crush them when you take them out of the packet.

Claritin (Loratadine) liquid may be easier for children to take than tablets. The medicine will come with a plastic syringe or spoon to help you measure out the right dose. If you don’t have a syringe or spoon, ask your pharmacist for one. Do not use a kitchen teaspoon as it will not give the right amount.

Claritin (Loratadine) tablets and melt-in-the-mouth tablets must only be taken by children aged between 2 and 12 years if they weigh 30kg or more. Give children Claritin (Loratadine) liquid if they weigh less than 30kg.

When to take it

You may only need to take Claritin (Loratadine) on a day you have symptoms, such as if you’ve been exposed to a trigger like animal hair. Or you may need to take it regularly to prevent symptoms, such as hay fever during spring and summer.

What should I do if I forget a dose?

Take your forgotten dose as soon as you remember, unless it is nearly time for your next dose. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a forgotten dose.

If you forget doses often, it may help to set an alarm to remind you. You could also ask your pharmacist for advice on other ways to help you remember to take your medicine.

What if I take too much?

Claritin (Loratadine) is generally very safe. Taking too much is unlikely to harm you or your child.

If you take an extra dose by mistake, you might get a headache, have a rapid heartbeat or feel sleepy. If this happens or you’re concerned, contact your doctor.

Claritin dosage

Claritin RediTabs 12-Hour

Active ingredient (in each tablet): Loratadine 5 mg (Antihistamine)

Inactive Ingredients: Anhydrous citric acid, gelatin, mannitol, mint flavor

Claritin RediTabs 12-Hour – WARNINGS

• Do not use if you have ever had an allergic reaction to this product or any of its ingredients
• Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.
• When using this product do not take more than directed. Taking more than directed may cause drowsiness.
• Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.
• If pregnant or breast-feeding, ask a health professional before use.
• Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Claritin RediTabs 12-Hour Uses

• Temporarily relieves:
  • Runny Nose
  • Sneezing
  • Itchy, Watery Eyes
  • Itchy Nose or Throat

Directions of use:

• Place 1 tablet on tongue; tablet disintegrates, with or without water.

Table 1. Claritin RediTabs 12-Hour Dosage Chart

Adults and children 6 years and over	1 tablet every 12 hours; not more than 2 tablets in 24 hours
Children under 6 years of age	Ask a doctor
Consumers with liver or kidney disease	Ask a doctor

Other information:

• Safety sealed. Do not use if the individual blister unit imprinted with Claritin® RediTabs® is open or torn.
• Store between 20° to 25°C (68° to 77°F)
• Use tablet immediately after opening individual blister.
• Complies with USP Procedure 2 for Assay and Organic Impurities and Test 2 for Disintegration.

Claritin Tablets 24-Hour

Active ingredient (in each tablet): Loratadine 10 mg (Antihistamine)

Inactive Ingredients: Corn starch, lactose monohydrate, magnesium stearate

Claritin Tablets 24-Hour – WARNINGS

• Do not use if you have ever had an allergic reaction to this product or any of its ingredients
• Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.
• When using this product do not take more than directed. Taking more than directed may cause drowsiness.
• Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.
• If pregnant or breast-feeding, ask a health professional before use.
• Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Claritin Tablets 24-Hour Uses

• Temporarily relieves:
  • Runny Nose
  • Sneezing
  • Itchy, Watery Eyes
  • Itchy Nose or Throat

Directions of use:

Table 2. Claritin Tablets 24-Hour Dosage Chart

Adults and children 6 years and over	1 tablet daily; not more than 1 tablet in 24 hours
Children under 6 years of age	Ask a doctor
Consumers with liver or kidney disease	Ask a doctor

Other information:

• Safety sealed. Do not use if the individual blister unit imprinted with Claritin is open or torn (applies to blisters).
• Tamper-evident: do not use if foil seal under cap, printed with “SEALED for YOUR PROTECTION” is missing, open, or broken (applies to bottles).
• Store between 20° to 25°C (68° to 77°F)
• Protect from excessive moisture

Claritin RediTabs 24-Hour

Active ingredient (in each tablet): Loratadine 10 mg (Antihistamine)

Inactive Ingredients: Anhydrous citric acid, gelatin, mannitol, mint flavor

Claritin RediTabs 24-Hour – WARNINGS

• Do not use if you have ever had an allergic reaction to this product or any of its ingredients
• Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.
• When using this product do not take more than directed. Taking more than directed may cause drowsiness.
• Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.
• If pregnant or breast-feeding, ask a health professional before use.
• Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Claritin RediTabs 24-Hour Uses

• Temporarily relieves:
  • Runny Nose
  • Sneezing
  • Itchy, Watery Eyes
  • Itchy Nose or Throat

Directions of use:

• Place 1 tablet on tongue; tablet disintegrates, with or without water.

Table 3. Claritin RediTabs 24-Hour Dosage Chart

Adults and children 6 years and over	1 tablet daily; not more than 1 tablet in 24 hours
Children under 6 years of age	Ask a doctor
Consumers with liver or kidney disease	Ask a doctor

Other information:

• Safety sealed. Do not use if the individual blister unit imprinted with Claritin® RediTabs® is open or torn.
• Store between 20° to 25°C (68° to 77°F)
• Use tablet immediately after opening individual blister.
• Complies with USP Procedure 2 for Assay and Organic Impurities and Test 2 for Disintegration.

Claritin Liqui-Gels Capsules 24-Hour

Active ingredient (in each tablet): Loratadine 10 mg (Antihistamine)

Inactive Ingredients: Caprylic/capric glycerides, FD&C blue no.1, gelatin, glycerin, pharmaceutical ink, polysorbate 80, povidone, purified water, sorbitol

Claritin Liqui-Gels Capsules 24-Hour – WARNINGS

• Do not use if you have ever had an allergic reaction to this product or any of its ingredients
• Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.
• When using this product do not take more than directed. Taking more than directed may cause drowsiness.
• Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.
• If pregnant or breast-feeding, ask a health professional before use.
• Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
• Safety sealed. Do not use if the individual blister unit imprinted with Claritin® Liqui-Gels® is open or torn.

Claritin Liqui-Gels Capsules 24-Hour Uses

• Temporarily relieves:
  • Runny Nose
  • Sneezing
  • Itchy, Watery Eyes
  • Itchy Nose or Throat

Directions of use:

Table 4. Claritin Liqui-Gels Capsules 24-Hour Dosage Chart

Adults and children 6 years and over	1 capsule daily; not more than 1 capsule in 24 hours
Children under 6 years of age	Ask a doctor
Consumers with liver or kidney disease	Ask a doctor

Other information:

• Safety sealed. Do not use if the individual blister unit imprinted with Claritin® Liqui-Gels® is open or torn.
• Store between 20° to 25°C (68° to 77°F)
• Protect from freezing

Children’s Claritin Syrup 24-Hour

Active ingredient (in each tablet): Loratadine 5 mg in each 5mL teaspoonful (Antihistamine)

Inactive Ingredients: Edetate disodium, flavor, glycerin, maltitol, monobasic sodium phosphate, phosphoric acid, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose

Children’s Claritin Syrup 24-Hour – WARNINGS

• Do not use if you have ever had an allergic reaction to this product or any of its ingredients
• Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.
• When using this product do not take more than directed. Taking more than directed may cause drowsiness.
• Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.
• If pregnant or breast-feeding, ask a health professional before use.
• Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Children’s Claritin Syrup 24-Hour Uses

• Temporarily relieves:
  • Runny Nose
  • Sneezing
  • Itchy, Watery Eyes
  • Itchy Nose or Throat

Directions of use:

• Use only with enclosed dosing cup.

Table 5. Children’s Claritin Syrup 24-Hour Dosage Chart

Adults and children 6 years and over	2 teaspoonfuls (tsp) daily; do not take more than 2 teaspoonfuls (tsp) in 24 hours
Children 2 to under 6 years of age	1 teaspoonful (tsp) daily; do not take more than 1 teaspoonful (tsp) in 24 hours
Children under 2 years of age	Ask a doctor
Consumers with liver or kidney disease	Ask a doctor

Other information:

• Each teaspoon contains: sodium 5 mg
• Do not use if tape imprinted with “SEALED FOR YOUR PROTECTION” on tap and bottom flaps of carton is not intact
• Store between 20° to 25°C (68° to 77°F)

Claritin side effects

Like all medicines, Claritin (Loratadine) can cause side effects although not everyone gets them.

Reported adverse events with an incidence of more than 2% in Loratadine, 10 mg/daily versus placebo-controlled allergic rhinitis clinical trials percent of patients reporting: Headache (12%), Somnolence (8%), Fatigue (4%), Dry Mouth (3%) ⁹.

Common side effects

The most common side effect of Claritin (Loratadine) is feeling sleepy. This happens in more than 1 in 100 people.

Children may also have a headache, feel tired or feel nervous. Talk to your doctor or pharmacist if these side effects bother you or don’t go away.

Tell your doctor if any of these symptoms are severe or do not go away:

• headache
• dry mouth
• nosebleed
• sore throat
• mouth sores
• difficulty falling asleep or staying asleep
• nervousness
• weakness
• stomach pain
• diarrhea
• red or itchy eyes

The following adverse events have been reported in 2% or fewer patients ⁹:

Autonomic Nervous System

Altered lacrimation, altered salivation, flushing, hypesthesia, impotence, increased sweating, thirst.

Body As a Whole

Angioneurotic edema, asthenia, back pain, blurred vision, chest pain, conjunctivitis, earache, eye pain, fever, leg cramps, malaise, rigors, tinnitus, upper respiratory infection, weight gain.

Cardiovascular System

Hypertension, hypotension, palpitations, syncope, tachycardia.

Central and Peripheral Nervous System

Blepharospasm, dizziness, dysphonia, hyperkinesia, migraine, paresthesia, tremor, vertigo.

Gastrointestinal System

Abdominal distress, altered taste, anorexia, constipation, diarrhea, dyspepsia, flatulence, gastritis, increased appetite, nausea, stomatitis, toothache, vomiting.

Musculoskeletal System

Arthralgia, myalgia. Psychiatric: Agitation, amnesia, anxiety, confusion, decreased libido, depression, impaired concentration, insomnia, nervousness, paroniria.

Reproductive System

Breast pain, dysmenorrhea, menorrhagia, vaginitis.

Respiratory System

Bronchitis, bronchospasm, coughing, dyspnea, epistaxis, hemoptysis, laryngitis, nasal congestion, nasal dryness, pharyngitis, sinusitis, sneezing.

Skin and Appendages

Dermatitis, dry hair, dry skin, photosensitivity reaction, pruritus, purpura, rash, urticaria.

Urinary System

Altered micturition, urinary discoloration.

Some side effects may be serious.

Serious side effects

A serious allergic reaction is an emergency. Contact a doctor straight away if you think you or someone around you is having a serious allergic reaction.

If you experience any of the following symptoms, stop taking Claritin (Loratadine) and call your doctor immediately:

• rash
• hives
• itching
• swelling of the eyes, face, lips, tongue, throat, hands, arms, feet, ankles, or lower legs
• hoarseness
• difficulty breathing or swallowing
• wheezing

In rare cases, Claritin (Loratadine) may cause a serious allergic reaction.

The warning signs of a serious allergic reaction are:

• getting a skin rash that may include itchy, red, swollen, blistered or peeling skin
• wheezing
• tightness in the chest or throat
• having trouble breathing or talking
• swelling of the mouth, face, lips, tongue, or throat

These are not all the side effects of Claritin (Loratadine). For a full list see the leaflet inside your medicines packet.

How to cope with side effects

What to do about:

• feeling sleepy – try a different non-drowsy antihistamine. If this doesn’t help, talk to your doctor.

Human Toxicity Reports

Somnolence, tachycardia, and headache have been reported with overdoses greater than 10 mg (40 to 180 mg) ¹⁰.

Use of antihistamines is not recommended in newborn or premature infants because this age group has an increased susceptibility to anticholinergic side effects, such as central nervous system (CNS) excitation, and an increased tendency toward convulsions ¹¹. A paradoxical reaction characterized by hyperexcitability may occur in children taking antihistamines ¹¹.

Dizziness, sedation, confusion, and hypotension may be more likely to occur in geriatric patients taking antihistamines ¹¹. A paradoxical reaction characterized by hyperexcitability may occur in geriatric patients taking antihistamines. Geriatric patients are especially susceptible to the anticholinergic side effects, such as dryness of mouth and urinary retention (especially in males), of the antihistamines. If these side effects occur and continue or are severe, medication should probably be discontinued.

Claritin overdose

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can’t be awakened, immediately call your emergency services number.

Symptoms of Claritin (Loratadine) overdose may include:

• fast or pounding heartbeat
• drowsiness
• headache
• unusual body movements

References

1. Bruttmann G, et al; J Allergy Clin Immunol 83 (2 Pt 1): 411-16; 1989 https://www.ncbi.nlm.nih.gov/pubmed/2563743
2. Powell RJ, Du Toit GL, Siddique N et al. BSACI guidelines for the management of chronic urticaria and angio-oedema. Clin Exp Allergy. 2007;37:631-50 https://www.ncbi.nlm.nih.gov/pubmed/17456211
3. Hilbert J, Radwanski E, Affine MB et al. Excretion of loratadine in human breast milk. J Clin Pharmacol. 1988;28:234-9. https://www.ncbi.nlm.nih.gov/pubmed/2966185
4. Merlob P, Stahl B. Prospective follow-up of adverse reactions in breast-fed infants exposed to loratadine treatment (1999-2001). BELTIS Newsl. 2002;Number 10:43-51.
5. Messinis IE, Souvatzoglou A, Fais N et al. Histamine H1 receptor participation in the control of prolactin secretion in postpartum. J Endocrinol Invest. 1985;8:143-6 https://www.ncbi.nlm.nih.gov/pubmed/3928731
6. Merlob P. Prospective follow-up of adverse reactions in breast-fed infants exposed to maternal loratadine treatment; 1999-2002
7. Pontiroli AE, De Castro e Silva E, Mazzoleni F et al. The effect of histamine and H1 and H2 receptors on prolactin and luteinizing hormone release in humans: sex differences and the role of stress. J Clin Endocrinol Metab. 1981;52:924-8 https://www.ncbi.nlm.nih.gov/pubmed/7228996
8. PDR; Physicians’ Desk Reference. 50th Ed. Montvale, NJ: Medical Economics Co. p.2349; 1996
9. PDR; Physicians’ Desk Reference. 50th Ed. Montvale, NJ: Medical Economics Co. p.2350;1996
10. PDR; Physicians’ Desk Reference. 50th Ed. Montvale, NJ: Medical Economics Co. p.2350; 1996
11. USP Convention. USPDI – Drug Information for the Health Care Professional. 16th ed. Volume I. Rockville, MD: U.S. Pharmaceutical Convention, Inc. 1996 (Plus updates)., p. 327

What is Advil

Advil is a medicine that contains a nonsteroidal anti-inflammatory drug (NSAID) – Ibuprofen and is available over-the-counter to relieve pain and reduce fever. Advil (ibuprofen) is a nonsteroidal anti-inflammatory drug (NSAID) used to treat mild to moderate pain, fever and pain caused by inflammation. Advil helps to relieve symptoms of arthritis (osteoarthritis, rheumatoid arthritis, or juvenile arthritis), such as inflammation, swelling, stiffness, and joint pain. Advil does not cure arthritis and will help you only as long as you continue to take it. In addition, Advil (ibuprofen) can be used to treat fever, menstrual cramps, and other conditions as determined by your doctor.

You can buy most types of Advil (ibuprofen) from pharmacies and supermarkets. Some types are only available on prescription.

Advil (ibuprofen) works by inhibiting the enzymes Cyclooxygenase 1 (COX-1) and Cyclooxygenase 2 (COX-2) by reducing hormones prostaglandin that cause inflammation, fever and pain in your body ¹. Advil (ibuprofen) reduces the ability of your body to make prostaglandins – chemicals that promote pain, inflammation and fever. With fewer prostaglandins in your body, fever eases off, and pain and inflammation is reduced. Cyclooxygenase 1 (COX-1) is constitutively active and is expressed in most tissues, including kidney, lung, stomach, duodenum, jejunum, ileum, colon, and cecum. Cyclooxygenase 1 (COX-1) functions in gastric cytoprotection, vascular homeostasis, platelet aggregation, and maintenance of normal kidney function ². Cyclooxygenase 2 (COX-2) is an inducible enzyme expressed in the brain, kidney, and possibly in the female reproductive system ². Cyclooxygenase 2 (COX-2) expression is increased during states of inflammation ³. Cyclooxygenase 2 (COX-2) is a key source of prostacyclin (PGI2) and is cardioprotective in ischemia–reperfusion injury ³. Advil (ibuprofen) analgesic activity is primarily (although not exclusively) associated with inhibition of COX-2, while different side effects result from the inhibition of COX-1 and COX-2 ⁴.

Key facts

• Advil (ibuprofen) takes 20 to 30 minutes to work if you take it by mouth.
• Advil (ibuprofen) works by reducing hormones that cause pain and swelling in the body.
• Advil (ibuprofen) is typically used for period pain or toothache. Some people find Advil (ibuprofen) better than paracetamol for back pain.
• Always take Advil (ibuprofen) tablets and capsules with food or a drink of milk to reduce the chance of an upset tummy. Don’t take it on an empty stomach.
• If you’re taking tablets, take the lowest dose for the shortest time. Don’t use it for a long time unless you’ve talked about it with your doctor.

Advil PM combines both ibuprofen (NSAID) with an antihistamine – Diphenhydramine – that reduces the effects of natural chemical histamine in your body. Advil PM is a combination medicine used to treat occasional insomnia associated with minor aches and pains. Advil PM is not for use in treating sleeplessness without pain, or sleep problems that occur often.

Advil PM is a combination medicine used to treat occasional insomnia associated with minor aches and pains.

Advil PM combines both ibuprofen (NSAID) with an antihistamine – Diphenhydramine, which provides powerful pain relief and helps you fall asleep and stay asleep.

Advil PM is not for use in treating sleeplessness without pain, or sleep problems that occur often.

• Diphenhydramine is an antihistamine that reduces the effects of natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.
• Diphenhydramine is used to treat sneezing, runny nose, watery eyes, hives, skin rash, itching, and other cold or allergy symptoms.
• Diphenhydramine is also used to treat motion sickness, to induce sleep, and to treat certain symptoms of Parkinson’s disease.

Important information on Diphenhydramine (Advil PM)

When taking diphenhydramine, use caution driving, operating machinery, or performing other hazardous activities. Diphenhydramine may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities.

Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while taking diphenhydramine.

Diphenhydramine side effects

Get emergency medical help if you have any signs of an allergic reaction to diphenhydramine: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using diphenhydramine (Advil PM) and call your doctor at once if you have:

• pounding heartbeats or fluttering in your chest;
• painful or difficult urination;
• little or no urinating;
• confusion, feeling like you might pass out; or
• tightness in your neck or jaw, uncontrollable movements of your tongue.

Common diphenhydramine side effects may include:

• dizziness, drowsiness, loss of coordination;
• dry mouth, nose, or throat;
• constipation, upset stomach;
• dry eyes, blurred vision; or
• day-time drowsiness or “hangover” feeling after night-time use.

Is Advil ibuprofen?

Yes. Advil contains ibuprofen – an active ingredient that provides powerful pain relief.

How long does it take for Advil to work?

You should start to feel better 20 to 30 minutes after taking Advil (ibuprofen) by mouth.

For some types of long-term pain, you’ll need to take Advil (ibuprofen) regularly for up to 3 weeks for it to work properly.

If you’re applying ibuprofen to your skin, it should start to work within 1 to 2 days.

Taking Advil with other painkillers

It’s safe to take Advil (ibuprofen) with acetaminophen or codeine.

But don’t take Advil (ibuprofen) with similar painkillers like aspirin or naproxen (Aleve) without talking to a doctor.

Advil (ibuprofen), aspirin and naproxen belong to the same group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). If you take them together, Advil (ibuprofen) plus aspirin or naproxen may increase the chance of you getting side effects like stomach ache.

Alternatives to Advil

For treating fever, an alternative to Advil (ibuprofen) is acetaminophen (Tylenol).

For pain or inflammation-related swelling, ask your doctor or pharmacist for an alternative if Advil (ibuprofen) is not suitable for you. Your health professional may suggest you try:

• acetaminophen (paracetamol)
• another medicine from the NSAID family
• a medicine that combines codeine with acetaminophen or Advil (ibuprofen) in the same tablet.

If your pain is severe, your doctor may prescribe you a stronger pain reliever.

Is Advil better than acetaminophen or aspirin?

Advil (ibuprofen), acetaminophen (paracetamol) and aspirin are all effective painkillers.

Advil (ibuprofen) is good for period pain and migraines. It can also be used for back pain, strains and sprains, as well as pain from arthritis.

Acetaminophen (Tylenol) is typically used for mild or moderate pain. It may be better than Advil (ibuprofen) for headaches, toothache, sprains, stomach ache, and nerve pain like sciatica.

Aspirin works in a similar way to Advil (ibuprofen). Like Advil (ibuprofen), it’s good for period pain and migraines. (If you have heavy periods, it can make them heavier.)

How long will I take Advil tablets for?

If you’re taking Advil (ibuprofen) for a short-lived pain like toothache or period pain, you may only need to take it for a day or two.

You may need to take Advil (ibuprofen) for longer if you have a long-term health problem, such as rheumatoid arthritis.

If you need to take Advil (ibuprofen) for more than 6 months, your doctor may prescribe a medicine to protect your stomach from any side effects.

Can I take Advil for a long time?

It’s safe to take Advil (ibuprofen) regularly for many years if you need to as long as you don’t take more than the recommended dosage.

If you need to take Advil (ibuprofen) by mouth for a long time and you’re at risk of getting a stomach ulcer, your doctor may prescribe a medicine to help protect your stomach.

Does Advil cause stomach ulcers?

Advil (ibuprofen) can cause ulcers in your stomach or gut, especially if you take it by mouth for a long time or in big doses.

If you need to take Advil (ibuprofen) and you’re at risk of getting a stomach ulcer, your doctor may prescribe a medicine to help protect your stomach.

Can I drink alcohol with Advil?

It’s usually safe to drink alcohol while taking Advil (ibuprofen). But if you’re taking Advil (ibuprofen) by mouth, drinking too much alcohol may irritate your stomach and increases your risk of getting stomach ulcers.

Is there any food or drink I need to avoid?

You can eat and drink normally while taking any type of Advil (ibuprofen).

It’s best to take Advil (ibuprofen) tablets, capsules or syrup with, or just after, a meal so it doesn’t upset your stomach. Don’t take it on an empty stomach.

What if Advil doesn’t work?

If Advil (ibuprofen) doesn’t work, there are other everyday painkillers you can try, such as:

• acetaminophen (paracetamol)
• aspirin
• co-codamol (acetaminophen combined with low-dose codeine)

If pharmacy painkillers don’t work, your doctor may be able to prescribe a stronger painkiller or recommend another treatment, such as exercise or physiotherapy.

Advil (ibuprofen) doesn’t work for certain types of pain – for example, nerve pain like sciatica. Your doctor will have to prescribe a different medicine if your pain is related to your nerves.

Will Advil affect my fertility?

Taking Advil (ibuprofen) by mouth, in large doses, or for a long time can affect ovulation in women, possibly making it more difficult for you to get pregnant. This is usually reversible when you stop taking Advil (ibuprofen).

Don’t take Advil (ibuprofen) tablets, capsules or syrup if you’re trying for a baby. Acetaminophen (Paracetamol) is a better option.

Will Advil affect my contraception?

Advil (ibuprofen) – by mouth or on your skin – doesn’t affect any contraceptives, including the contraceptive pill and the morning after pill.

Pregnancy and breastfeeding

Advil (ibuprofen) isn’t normally recommended in pregnancy.

It may cause birth defects affecting the baby’s heart or blood vessels. There may also be a link between taking Advil (ibuprofen) in early pregnancy and miscarriage.

Acetaminophen (paracetamol) is the best painkiller to take during pregnancy.

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

This medicine may be harmful to an unborn baby. Taking ibuprofen during the last 3 months of pregnancy may result in birth defects and prolonged labor and delivery. Do not use this medicine without a doctor’s advice if you are pregnant.

Use in late pregnancy should be avoided. May constrict ductus arteriosus in utero or inhibit or prolong labor as result of inhibition of prostaglandin synthetase ⁵.

For safety, tell your pharmacist or doctor if you’re trying to get pregnant, are already pregnant or if you’re breastfeeding.

To assess the fetal effects of exposure to ibuprofen overdose in pregnancy ⁶. Ibuprofen, a non-steroidal anti-inflammatory drug (NSAID) is a frequently used analgesic that is readily available over the counter. Concerns have been raised that therapeutic use of NSAIDs is associated with an increased risk of miscarriage and renal dysfunction. Although most acute overdoses are of low toxicity, few data exist on the potential fetotoxicity of ibuprofen overdose during pregnancy. Using standardized procedures, National Technical Information Service (NTIS) has provided fetal risk assessment and collected outcome data on a prospective case series of 100 women who took ibuprofen in overdose during pregnancy. Results are the majority of liveborn infants (66/73=90.4%) had no congenital anomalies. No pattern of anomalies was observed. Multidrug overdoses in which ibuprofen was the major constituent were taken by 68%, mainly compound analgesics and cold remedies with 28% taking paracetamol. The majority (86%) of overdoses occurred in the first trimester with only 9 (9%) reports of any significant maternal toxicity including 1 mother who was unconscious. Conclusion: The incidence of miscarriages (9% versus 10-20%) and terminations (18% versus 23%) is within the expected range ⁶. However, the incidence of congenital anomalies is higher (7/73=9.6% versus 2-3% expected), but two exposures were second trimester, and the numbers are small. Although no pattern of malformations was seen, three were cardiac anomalies ⁶. As congenital heart anomalies are common 0.5-1% it is not possible to establish a causal relationship with the drugs taken in overdose. No cases of renal dysfunction were seen. In the majority of women who receive appropriate treatment at the time of the overdose the outcome of pregnancy is a normal baby ⁶.

Advil (ibuprofen) and breastfeeding

Advil (ibuprofen) is safe to take by mouth if you are breastfeeding.

Two early studies attempted measurement of ibuprofen in milk ⁷, ⁸. In one, the patient’s dose was 400 mg twice daily, while in the second study of 12 patients, the dose was 400 mg every 6 hours. Ibuprofen was undetectable in breastmilk in both studies (<0.5 and 1 mg/L, respectively) ⁷, ⁸.

A later study using a more sensitive assay found ibuprofen in the breastmilk of one woman who took 6 doses of 400 mg orally over a 42.5 hours. A milk ibuprofen level of 13 mcg/L was detected 30 minutes after the first dose. The highest level measured was 180 mcg/L about 4 hours after the third dose, 20.5 hours after the first dose. The authors estimated that the infant would receive about 17 mcg/kg daily (100 mcg daily) with the maternal dose of approximately 1.2 grams daily. This dose represents 0.0008% of the maternal weight-adjusted dosage ⁹ and 0.06% of the commonly accepted infant dose of 30 mg/kg daily (10 mg/kg every 8 hours).

Single milk samples were taken from 13 women between 1.5 and 8 hours after the third dose of ibuprofen in a daily dosage regimen averaging 1012 mg daily (range 400 to 1200 mg daily). Of the 13 milk samples analyzed, the mean milk concentration was 361 mcg/L (range 164 to 590 mcg/L). The mean weight-adjusted percentage of the maternal dosage (relative infant dosage) was estimated to be <0.38%; however, the relative infant dosage varied with the time postpartum and the milk protein content. The relative infant dosage was highest in the colostral phase when the milk protein content was the highest (relative infant dosage 0.6%). The estimated mean dosage for a fully breastfed infants was 68 mcg/kg daily or 0.2% of a pediatric dosage ¹⁰.

What is Advil (ibuprofen) used for?

Advil (ibuprofen) can be used for the short-term relief of fever, mild to moderate pain and inflammation (redness, swelling and soreness).

Advil (ibuprofen) might ease some of the symptoms of:

• headaches e.g. migraines or tension headache
• sinus pain
• toothache and pain after dental procedures
• backache, muscular aches and pains
• period pain/primary dysmenorrhea
• sore throat
• joint or tendon sprains and strains such as tennis elbow
• arthritis
• fever (pyrexia) or high temperature.
• Advil (ibuprofen) is also indicated for the relief of acute and/or chronic pain states in which there is an inflammatory component. For example, Rheumatoid arthritis, Juvenile rheumatoid arthritis and Osteoarthritis

Please note that Advil (ibuprofen) provides only temporary relief – it won’t cure your condition.

Advil vs Ibuprofen

Advil is a medicine that contains a nonsteroidal anti-inflammatory drug (NSAID) – Ibuprofen.

Who can and can’t take Advil

Some brands of Advil (ibuprofen) tablets, capsules and syrup contain aspartame, colors (E numbers), gelatin, glucose, lactose, sodium, sorbitol, soya or sucrose, so they may be unsuitable for some people.

Don’t take Advil (ibuprofen) by mouth if you:

• have had an allergic reaction to Advil (ibuprofen) or any other medicines in the past
• have previously had a reaction, such as asthma, a raised, itchy red rash (urticaria), swelling underneath your skin (angioedema) or swelling of the inside of your nose (rhinitis)
• have taken aspirin or any other nonsteroidal anti-inflammatory drug (NSAID)
• have asthma or another allergic illness
• are trying to get pregnant, are already pregnant or if you’re breastfeeding

To make sure Advil (ibuprofen) (by mouth) is safe for you, tell your doctor or pharmacist if you have:

• had bleeding in your stomach, a stomach ulcer, or a perforation (a hole) in your stomach
• a health problem that means you have an increased chance of bleeding
• liver problems, such as liver fibrosis, cirrhosis or liver failure
• heart disease or severe heart failure
• kidney failure
• Crohn’s disease or ulcerative colitis
• chickenpox or shingles – taking Advil (ibuprofen) can increase the chance of certain infections and skin reactions

Cautions with other medicines

Advil (ibuprofen) doesn’t mix well with some medicines.

Advil (ibuprofen) applied to the skin is less likely to interfere with other medicines than if it’s taken by mouth.

For safety, tell your doctor if you’re taking these medicines before you start taking Advil (ibuprofen) by mouth or on your skin:

• blood-thinning medicines such as warfarin
• anti-inflammatory painkillers such as aspirin, diclofenac, mefenamic acid and naproxen
• medicines for high blood pressure
• steroid medicines such as betamethasone, dexamethasone, hydrocortisone or prednisolone
• antibiotics such as ciprofloxacin, levofloxacin, moxifloxacin, nalidixic acid, norfloxacin or ofloxacin
• antidepressants such as citalopram, fluoxetine, fluvoxamine, venlafaxine, paroxetine or sertraline
• diabetes medicines such as gliclazide, glimepiride, glipizide and tolbutamide

How should Advil be used?

Prescription Advil (ibuprofen) comes as a tablet to take by mouth. It is usually taken three or four times a day for arthritis or every 4 to 6 hours as needed for pain. Nonprescription Advil (ibuprofen) comes as a tablet, chewable tablet, suspension (liquid), and drops (concentrated liquid). Adults and children older than 12 years of age may usually take nonprescription Advil (ibuprofen) every 4 to 6 hours as needed for pain or fever. Children and infants may usually be given nonprescription Advil (ibuprofen) every 6 to 8 hours as needed for pain or fever, but should not be given more than 4 doses in 24 hours. Advil (ibuprofen) may be taken with food or milk to prevent stomach upset. If you are taking Advil (ibuprofen) on a regular basis, you should take it at the same time(s) every day. Follow the directions on the package or prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take Advil (ibuprofen) exactly as directed. Do not take more or less of it or take it more often than directed by the package label or prescribed by your doctor.

Advil (ibuprofen) comes alone and in combination with other medications. Some of these combination products are available by prescription only, and some of these combination products are available without a prescription and are used to treat cough and cold symptoms and other conditions. If your doctor has prescribed a medication that contains Advil (ibuprofen), you should be careful not to take any nonprescription medications that also contain Advil (ibuprofen).

If you are selecting a product to treat cough or cold symptoms, ask your doctor or pharmacist for advice on which product is best for you. Check nonprescription product labels carefully before using two or more products at the same time. These products may contain the same active ingredient(s) and taking them together could cause you to receive an overdose. This is especially important if you will be giving cough and cold medications to a child.

Nonprescription cough and cold combination products, including products that contain Advil (ibuprofen), can cause serious side effects or death in young children. Do not give these products to children younger than 4 years of age. If you give these products to children 4 to 11 years of age, use caution and follow the package directions carefully.

If you are giving Advil (ibuprofen) or a combination product that contains Advil (ibuprofen) to a child, read the package label carefully to be sure that it is the right product for a child of that age. Do not give Advil (ibuprofen) products that are made for adults to children.

Before you give an Advil (ibuprofen) product to a child, check the package label to find out how much medication the child should receive. Give the dose that matches the child’s age on the chart. Ask the child’s doctor if you don’t know how much medication to give the child.

Shake the suspension and drops well before each use to mix the medication evenly. Use the measuring cup provided to measure each dose of the suspension, and use the dosing device provided to measure each dose of the drops.

The chewable tablets may cause a burning feeling in the mouth or throat. Take the chewable tablets with food or water.

Stop taking nonprescription Advil (ibuprofen) and call your doctor if your symptoms get worse, you develop new or unexpected symptoms, the part of your body that was painful becomes red or swollen, your pain lasts for more than 10 days, or your fever lasts more than 3 days. Stop giving nonprescription Advil (ibuprofen) to your child and call your child’s doctor if your child does not start to feel better during the first 24 hours of treatment. Also stop giving nonprescription Advil (ibuprofen) to your child and call your child’s doctor if your child develops new symptoms, including redness or swelling on the painful part of his body, or if your child’s pain or fever get worse or lasts longer than 3 days.

Do not give nonprescription Advil (ibuprofen) to a child who has a sore throat that is severe or does not go away, or that comes along with fever, headache, nausea, or vomiting. Call the child’s doctor right away, because these symptoms may be signs of a more serious condition.

Other uses for Advil

Advil (ibuprofen) is also sometimes used to treat ankylosing spondylitis (arthritis that mainly affects the spine), gouty arthritis (joint pain caused by a build-up of certain substances in the joints), and psoriatic arthritis (arthritis that occurs with a long-lasting skin disease that causes scaling and swelling). Talk to your doctor about the risks of using this drug for your condition.

This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking Advil

• tell your doctor and pharmacist if you are allergic to Advil (ibuprofen), aspirin or other NSAIDs such as ketoprofen and naproxen (Aleve, Naprosyn), any other medications, or any of the inactive ingredients in the type of Advil (ibuprofen) you plan to take. Ask your pharmacist or check the label on the package for a list of the inactive ingredients.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention the medications listed in the IMPORTANT WARNING section and any of the following: angiotensin-converting enzyme (ACE) inhibitors such as benazepril (Lotensin, in Lotrel), captopril, enalapril (Vasotec, in Vaseretic), fosinopril, lisinopril (in Zestoretic), moexipril (Univasc), perindopril (Aceon, in Prestalia), quinapril (Accupril, in Quinaretic), ramipril (Altace), and trandolapril (Mavik, in Tarka); angiotensin receptor blockers such as candesartan (Atacand, in Atacand HCT), eprosartan (Teveten), irbesartan (Avapro, in Avalide), losartan (Cozaar, in Hyzaar), olmesartan (Benicar, in Azor, in Benicar HCT, in Tribenzor), telmisartan (Micardis, in Micardis HCT, in Twynsta), and valsartan (in Exforge HCT); beta blockers such as atenolol (Tenormin, in Tenoretic), labetalol (Trandate), metoprolol (Lopressor, Toprol XL, in Dutoprol), nadolol (Corgard, in Corzide), and propranolol (Hemangeol, Inderal, Innopran); diuretics (‘water pills’); lithium (Lithobid); and methotrexate (Otrexup, Rasuvo, Trexall). Your doctor may need to change the doses of your medications or monitor you more carefully for side effects.
• do not take nonprescription Advil (ibuprofen) with any other medication for pain unless your doctor tells you that you should.
• tell your doctor if you have or have ever had any of the conditions mentioned in the IMPORTANT WARNING section or asthma, especially if you also have frequent stuffed or runny nose or nasal polyps (swelling of the inside of the nose); heart failure; swelling of the hands, arms, feet, ankles, or lower legs; lupus (a condition in which the body attacks many of its own tissues and organs, often including the skin, joints, blood, and kidneys); or liver or kidney disease. If you are giving Advil (ibuprofen) to a child, tell the child’s doctor if the child has not been drinking fluids or has lost a large amount of fluid from repeated vomiting or diarrhea.
• tell your doctor if you are pregnant, especially if you are in the last few months of your pregnancy; you plan to become pregnant; or you are breast-feeding. If you become pregnant while taking Advil (ibuprofen), call your doctor.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking Advil (ibuprofen).
• if you have phenylketonuria (PKU, an inborn disease in which mental retardation develops if a specific diet is not followed), read the package label carefully before taking nonprescription Advil (ibuprofen). Some types of nonprescription Advil (ibuprofen) may be sweetened with aspartame, a source of phenylalanine.

Advil dosage

A few reminders:

• When taking any medicine, always read and follow the label carefully.
• Always keep the outer carton of Advil products.
• These ibuprofen dosage directions are for adults and children 12 years and older.
• Do not take more than directed.

How many Advil can I take?

The usual dose for adults is one or two 200mg tablets 3 times a day. If this isn’t enough, your doctor may prescribe a higher dose of up to 600mg to take 4 times a day.

If you take Advil (ibuprofen) 3 times a day, leave at least 6 hours between doses. If you take it 4 times a day, leave at least 4 hours between doses.

If you have pain all the time, your doctor may recommend slow-release Advil (ibuprofen) tablets or capsules. It’s usual to take these once a day in the evening or twice a day. Leave a gap of 10 to 12 hours between doses if you’re taking Advil (ibuprofen) twice a day.

For people who find it difficult to swallow tablets or capsules, Advil (ibuprofen) is available as a tablet that melts in your mouth, granules that you mix with a glass of water to make a drink, and as a syrup.

Swallow Advil (ibuprofen) tablets or capsules whole with a glass of water or milk. Don’t chew, break, crush or suck them as this could irritate your mouth or throat.

Always take Advil (ibuprofen) tablets and capsules after a meal or snack or with a drink of milk. It will be less likely to upset your tummy.

What if I forget to take it?

Take the missed dose as soon as you remember, unless it’s almost time for your next dose. In this case, skip the missed dose and take your next dose as normal.

Never take a double dose to make up for a forgotten one.

If you forget doses often, it may help to set an alarm to remind you. You could also ask your pharmacist for advice on other ways to help you remember to take your medicine.

What if I take too much?

Taking too much Advil (ibuprofen) by mouth can be dangerous. It can cause side effects such as:

• feeling sick and vomiting
• tummy pain
• feeling tired or sleepy
• black poo and blood in your vomit – a sign of bleeding in your stomach
• tinnitus (ringing in your ears)
• difficulty breathing or changes in your heart rate (slower or faster)

If you need to go to hospital, take the ibuprofen packet or leaflet inside it plus any remaining medicine with you.

Advil Tablets

Active Ingredient: Ibuprofen 200 mg in each tablet / caplets / gel caplets

Inactive Ingredients: acetylated monoglycerides, colloidal silicon dioxide, corn starch, croscarmellose sodium, methylparaben, microcrystalline cellulose, pharmaceutical glaze, pharmaceutical ink, povidone, pregelatinized starch, propylparaben, sodium benzoate, sodium lauryl sulfate, stearic acid, sucrose, synthetic iron oxide, titanium dioxide, white wax

Other information:

• read all warnings and directions before use. Keep carton.
• store at 20-25 °C (68-77 °F)
• avoid excessive heat above 40 °C (104 °F)

Advil Uses

• Temporarily relieves minor aches and pains due to:
  • Headache
  • Toothache
  • Backache
  • Menstrual cramps
  • The common cold
  • Muscular aches
  • Minor pain of arthritis
• Temporarily reduces fever

Dosing Information:

The smallest effective dose should be used

• 12 years of age and older:
  • 1 tablet/caplet/gel caplet every 4 to 6 hours while symptoms persist.
  • If pain or fever does not respond to 1 tablet/caplet/gel caplet, 2 may be used.
  • Do not exceed 6 tablets/caplets/gel caplets in 24 hours unless directed by a doctor.
• Under 12 years of age: Ask a doctor.

Advil Warnings

Allergy alert

Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

• hives
• facial
• swelling
• asthma (wheezing)
• shock
• skin reddening
• rash
• blisters

If an allergic reaction occurs, stop use and seek medical help right away.

Stomach bleeding warning

This product contains an nonsteroidal anti-inflammatory drug (NSAID), which may cause severe stomach bleeding. The chance is higher if you:

• are age 60 or older
• have had stomach ulcers or bleeding problems
• take a blood thinning (anticoagulant) or steroid drug
• take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
• have 3 or more alcoholic drinks every day while using this product
• take more or for a longer time than directed

Heart attack and stroke warning

Nonsteroidal anti-inflammatory drugs (NSAIDs), except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed

Do NOT use

• if you ever had an allergic reaction to any other pain reliever/fever reducer
• right before or after heart surgery

Ask a doctor before use if:

• stomach bleeding warning applies to you
• you have problems or serious side effects from taking pain relievers or fever reducers
• you have a history of stomach problems, such as heartburn
• you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke
• you are taking a diuretic

Ask a doctor or pharmacist before use if you are:

• under a doctor’s care for any serious condition
• taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
• taking any other drug

Stop use and ask a doctor if:

• you experiences any of the following signs of stomach bleeding:
  • feel faint
  • vomits blood
  • has bloody or black stools
  • has stomach pain that does not get better
• you have symptoms of heart problems or stroke:
  • chest pain
  • trouble breathing
  • weakness in one part or side of body
  • slurred speech
  • leg swelling
• you do not get any relief within first day (24 hours) of treatment
• pain gets worse or lasts more than 10 days
• fever gets worse or lasts more than 3 days
• redness or swelling is present in the painful area
• any new symptoms appear

Infants’ Advil Drops

Active Ingredient: Ibuprofen 50 mg in each 1.25mL

Inactive Ingredients: acetic acid, artificial flavor, butylated hydroxytoluene, carboxymethylcellulose sodium, citric acid monohydrate, edetate disodium, glycerin, microcrystalline cellulose, polysorbate 80, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucrose, xanthan gum

Infants’ Advil Drops Uses

• Temporarily reduces fever
• Temporarily relieves minor aches and pains due to the common cold, flu, headaches and toothaches

Dosing Information:

• Shake well before using
• Repeat dose every 6-8 hours, if needed
• Do not use more than 4 times a day
• Find right dose on chart below. If possible, use weight to dose; otherwise use age.
• Only use the measuring device that comes with the product to be sure you give the right dose.
• When using this product take with food or milk if stomach upset occurs.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Table 1. Infants’ Advil Drops Dosage

Weight (lb)	Age (months)	Dose (mL)
	Under 6 months	Ask a Doctor
12-17 lb	6-11 months	1.25 mL
18-23 lb	12-23 months	1.875 mL

Other information:

• one dose lasts 6-8 hours
• store at 20-25°C (68-77°F)
• see bottom of box for lot number and expiration date

Infants’ Advil Drops Warnings

Allergy alert

Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

• hives
• facial
• swelling
• asthma (wheezing)
• shock
• skin reddening
• rash
• blisters

If an allergic reaction occurs, stop use and seek medical help right away.

Stomach bleeding warning

This product contains an nonsteroidal anti-inflammatory drug (NSAID), which may cause severe stomach bleeding. The chance is higher if the child:

• has had stomach ulcers or bleeding problems
• takes a blood thinning (anticoagulant) or steroid drug
• takes other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
• takes more or for a longer time than directed

Heart attack and stroke warning

Nonsteroidal anti-inflammatory drugs (NSAIDs), except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed

Do NOT use

• if the child has ever had an allergic reaction to any other pain reliever/fever reducer
• right before or after heart surgery

Ask a doctor before use if:

• stomach bleeding warning applies to the child
• child has problems or serious side effects from taking pain relievers or fever reducers
• child has a history of stomach problems, such as heartburn
• child has high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke
• child has not been drinking fluids
• child has lost a lot of fluid due to vomiting or diarrhea
• child is taking a diuretic

Ask a doctor or pharmacist before use if the child is:

• under a doctor’s care for any serious condition
• taking any other drug

Stop use and ask a doctor if:

• child experiences any of the following signs of stomach bleeding:
  • feel faint
  • vomits blood
  • has bloody or black stools
  • has stomach pain that does not get better
• child has symptoms of heart problems or stroke:
  • chest pain
  • trouble breathing
  • weakness in one part or side of body
  • slurred speech
  • leg swelling
• child does not get any relief within first day (24 hours) of treatment
• fever or pain gets worse or lasts more than 3 days
• redness or swelling is present in the painful area
• any new symptoms appear

Children’s Advil Suspension

Active Ingredient: Ibuprofen 100 mg in each 5mL

Inactive Ingredients: artificial flavor, carboxymethylcellulose sodium, citric acid monohydrate, edetate disodium, glycerin, microcrystalline cellulose, polysorbate 80, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose, xanthan gum

• FRUIT FLAVOR: artificial flavor, carboxymethylcellulose sodium, citric acid monohydrate, edetate disodium, FD&C red no. 40, glycerin, microcrystalline cellulose, polysorbate 80, purified water, sodium benzoate, sorbitol solution, sucrose, xanthan gum
• GRAPE: acetic acid, artificial flavor, butylated hydroxytoluene, carboxymethylcellulose sodium, citric acid monohydrate, edetate disodium, FD&C blue no.1, FD&C red no. 40, glycerin, microcrystalline cellulose, polysorbate 80, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucrose, xanthan gum
• WHITE GRAPE: acetic acid, artificial flavor, butylated hydroxytoluene, carboxymethylcellulose sodium, citric acid monohydrate, edetate disodium, glycerin, microcrystalline cellulose, polysorbate 80, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucrose, xanthan gum
• BLUE RASPBERRY: artificial and natural flavors, carboxymethylcellulose sodium, citric acid monohydrate, edetate disodium, FD&C blue no. 1, glycerin, microcrystalline cellulose, polysorbate 80, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucrose, xanthan gum

Children’s Advil Suspension Uses

• Temporarily reduces fever
• Temporarily relieves minor aches and pains due to the common cold, flu, headaches and toothaches

Dosing Information:

• Shake well before using
• Repeat dose every 6-8 hours, if needed
• Do not use more than 4 times a day
• Find right dose on chart below. If possible, use weight to dose; otherwise use age.
• Only use the measuring device that comes with the product to be sure you give the right dose.
• When using this product take with food or milk if stomach upset occurs.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Table 2. Children’s Advil Suspension Dosage

Weight (lb)	Age (yrs)	Dose (tsp)
Under 24 lb	Under 2 Year	Ask a Doctor
24 – 35 lb	2 – 3 yr	1 tsp
36- 47 lb	4 – 5 yr	1 ½ tsp
48 – 59 lb	6 – 8 yr	2 tsp
60 – 71 lb	9 – 10 yr	2 ½ tsp
72 – 95 lb	11 yr	3 tsp

Other information:

• each 5 mL contains: sodium 3 mg (Grape, White Grape, Fruit, and Bubblegum)
• each 5 mL contains: sodium 10 mg (Blue Raspberry and Sugar Free/Dye Free Berry)
• one dose lasts 6-8 hours
• store at 20-25°C (68-77°F)
• see bottom of box for lot number and expiration date

Children’s Advil Suspension Warnings

Allergy alert

Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

• hives
• facial
• swelling
• asthma (wheezing)
• shock
• skin reddening
• rash
• blisters

If an allergic reaction occurs, stop use and seek medical help right away.

Stomach bleeding warning

This product contains an nonsteroidal anti-inflammatory drug (NSAID), which may cause severe stomach bleeding. The chance is higher if the child:

• has had stomach ulcers or bleeding problems
• takes a blood thinning (anticoagulant) or steroid drug
• takes other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
• takes more or for a longer time than directed

Heart attack and stroke warning

Nonsteroidal anti-inflammatory drugs (NSAIDs), except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed

Do NOT use

• if the child has ever had an allergic reaction to any other pain reliever/fever reducer
• right before or after heart surgery

Ask a doctor before use if:

• stomach bleeding warning applies to the child
• child has problems or serious side effects from taking pain relievers or fever reducers
• child has a history of stomach problems, such as heartburn
• child has high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke
• child has not been drinking fluids
• child has lost a lot of fluid due to vomiting or diarrhea
• child is taking a diuretic

Ask a doctor or pharmacist before use if the child is:

• under a doctor’s care for any serious condition
• taking any other drug

Stop use and ask a doctor if:

• child experiences any of the following signs of stomach bleeding:
  • feel faint
  • vomits blood
  • has bloody or black stools
  • has stomach pain that does not get better
• child has symptoms of heart problems or stroke:
  • chest pain
  • trouble breathing
  • weakness in one part or side of body
  • slurred speech
  • leg swelling
• child does not get any relief within first day (24 hours) of treatment
• fever or pain gets worse or lasts more than 3 days
• redness or swelling is present in the painful area
• any new symptoms appear.

Advil side effects

Common side effects

The common side effects of Advil (ibuprofen) taken by mouth happen in more than 1 in 100 people. Talk to your doctor or pharmacist if these side effects bother you or don’t go away:

• headache
• feeling dizzy
• feeling sick or vomiting
• wind and indigestion
• upset stomach e.g. nausea, diarrhea and indigestion
• headache
• dizziness
• high blood pressure
• fluid retention.

There can be extra risks if you take Advil (ibuprofen) when you are over 65, or have an ulcer, so discuss this with your doctor. Advil (ibuprofen), like all NSAIDs, can also make heart disease worse – talk to your doctor before taking Advil (ibuprofen) if you have any concerns.

Less common side effects include:

• feeling sleepy or anxious
• pins and needles
• problems with your eyesight
• hearing ringing in your ears
• difficulty falling asleep

Advil (ibuprofen) tablets and capsules can cause inflammation of the stomach (gastritis) and ulcers in your stomach, gut or mouth. It can also make it difficult to breathe, or make asthma worse.

Serious side effects

Serious side effects of ibuprofen that need immediate medical attention include:

• black poo or blood in your vomit – these can be signs of bleeding in your stomach
• swollen ankles, blood in your pee or not peeing at all – these can be signs of a kidney problem
• severe chest or tummy pain – these can be signs of a hole in your stomach or gut
• difficulty breathing

This is not a full list of side effects. For more information, talk to your doctor or pharmacist. Or, if you’re experiencing a serious or life-threatening side effect, immediately call your local emergency number immediately.

Serious allergic reaction

In rare cases, it’s possible to have a serious allergic reaction to Advil (ibuprofen).

• A serious allergic reaction is an emergency. Call your local emergency number straight away if you think you or someone around you is having a serious allergic reaction.

The warning signs of a serious allergic reaction are:

• getting a skin rash that may include itchy, red, swollen, blistered or peeling skin
• wheezing
• tightness in the chest or throat
• having trouble breathing or talking
• swelling of the mouth, face, lips, tongue, or throat

These are not all the side effects of Advil (ibuprofen) tablets, capsules and syrup. For a full list see the leaflet inside your medicines packet.

How to cope with side effects

What to do about:

• indigestion – stop taking Advil (ibuprofen) and see your doctor as soon as possible. If you need something to ease the discomfort, try taking an antacid, but don’t put off going to the doctor.
• feeling sick – stick to simple meals. Don’t eat rich or spicy food
• vomiting – have small, frequent sips of water. It may also help to take oral rehydration solutions like Pedialyte you can buy from a pharmacy or supermarket to prevent dehydration. Don’t take any other medicines to treat vomiting without speaking to a pharmacist or doctor.
• wind – try not to eat foods that cause wind (like pulses, lentils, beans and onions). Eat smaller meals, eat and drink slowly, and exercise regularly. There are pharmacy medicines that can also help, such as charcoal tablets or simethicone.
• your skin being sensitive to sunlight – stay out of bright sun and use a high factor sun cream (SPF 30 or above) even on cloudy days. Don’t use a sun lamp or sun beds.

Human Toxicity Reports

Gastrointestinal side effects are experienced by 5-15% of patients taking ibuprofen; epigastric pain, nausea, heartburn and sensations of “fullness” in the gastrointestinal tract are the usual difficulties ¹¹. However, the incidence of theses side effects is less with ibuprofen than with aspirin or indomethacin. Other side effects of ibuprofen have been reported less frequently. They include thrombocytopenia, skin rashes, headache, dizziness and blurred vision and in a few cases, toxic amblyopia, fluid retention and edema ¹¹.

Fatal autoimmune hemolytic anemai occurred coincident with oral administration of ibuprofen 400 mg 3 times per day in 49 yr old male ¹².

Healthy subjects treated for 2 weeks with 3 times daily ibuprofen showed a total blood loss of 9.7 ml. Mean daily blood loss was significantly higher than on placebo ¹³.

In ibuprofen overdose cases, the majority of patients had no symptoms or only mild symptoms such as nausea or vomiting. Lab analyses available for some cases demonstrate that plasma ibuprofen concentrations of up to 704 mg/L could be associated with no symptoms ¹⁴.

A case of aseptic meningoencephalitis induced by ibuprofen (Brufen) is decribed in a 24 year old unmarried woman with unrecognized systemic lupus erythematosus. The neurological manifestations induced by ibuprofen revealed the systemic disease. Clinicians confronted with aseptic meningitis or meningoencephalitis developed after treatment with a non-steroidal anti-inflammatory drug, notably ibuprofen, should investigate for systemic disease ¹⁵.

Ibuprofen (Motrin, Brufen) an anti inflammatory phenylpropionic derivative, was reported in 1971 to have caused reversible centrocecal field defects and reduced visual acuity in two patients, and a reversible “moving mosaic of colored lights in front of both eyes” in another ¹⁶. One patient was reported to have a drastic impairment of color vision & decr in visual acuity, which were largely reversible on discontinuing ibuprofen. Another patient on 2 occasions after taking ibuprofen has complained of seeing streaks shooting from lateral to central field of vision; eye exams were normal ¹⁶. Cortical visual evoked potentials were evaluated in a patient who had 20/50, 20/60 vision with decreased brightness of colors after taking ibuprofen for 2 months, showing decreased amplitudes & increased conduction times, but these became normal 6 days after the drug was stopped; vision became normal later ¹⁶.

In a series of 293 patients treated during a five year period no visual symptoms were detected that were thought attributable to the drug ¹⁶ and in another series of 247 patients there was no evidence of toxic amblyopia or maculopathy attributable to ibuprofen. A prospective study in 1975 reported no evidence of eye toxicity in 45 healthy volunteers treated for 3 months, or in 78 patients with osteoarthritis during 6 months ¹⁶.

Chemically induced renal dysfunction caused by ibuprofen is dose/duration related ¹⁷. Most common presentation renal insufficiency that can lead to acute or chronic renal failure. Cell-mediated nephrotic syndrome can occur. Short term use of moderate dose ibuprofen may result in /acute renal failure/ in patients with asymptomatic mild chronic renal failure.

Prostaglandins are known to be involved in the metabolism of bone, having a significant influence on bone resorption in cases of bone pathology ¹⁸. This study ¹⁸ investigated the short-term effects of two commonly used nonsteroidal anti-inflammatory drugs (NSAIDs), ibuprofen and acetaminophen (paracetamol), on bone resorption in healthy men. In a randomized, double-blind pilot study, 28 healthy, age- and weight-matched male volunteers were treated with ibuprofen (n = 10), acetaminophen (n = 9), or a placebo (n = 9) for 3 days. As an indication of bone resorption rate, levels of the biochemical bone markers N-telopeptide (NTx) and free deoxypyridinoline (D-Pyr) were measured in urine. Differences in resorption marker levels pre- and post-NSAID use were then compared between groups. The study authors ¹⁸ found that NTx concentrations in the acetaminophen group were lower than placebo, whereas NTx levels in the ibuprofen group were higher than in the acetaminophen group. By contrast, D-Pyr concentrations in the ibuprofen group were significantly lower than in the placebo group (p = 0.009). A comparison of the percentage changes of D-Pyr:NTx ratios found that the ratio in the ibuprofen group was significantly lower than that of both the control and acetaminophen groups. These results show the differential effects of ibuprofen and acetaminophen on urinary excretion of peptide-bound and free deoxypyridinoline cross-links of type I collagen. Short-term ibuprofen use may alter the renal handling of collagen cross-links and increase bone resorption to a greater extent than acetaminophen in normal men ¹⁸.

Advil overdose

Can you overdose on Advil? Yes

In case of Advil overdose

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can’t be awakened, immediately call your local emergency services number.

This is a free and confidential service. All local poison control centers in the United States use this national number. You should call if you have any questions about poisoning or poison prevention. You can call 24 hours a day, 7 days a week.

Symptoms of Advil overdosage may include:

• dizziness
• fast eye movements that you cannot control
• slow breathing or short periods of time without breathing
• blue color around the lips, mouth, and nose

Symptoms may develop in the following areas:

Eyes, ears, nose, throat, and mouth:

• Ringing in the ears
• Blurred vision

Gastrointestinal:

• Diarrhea
• Heartburn
• Nausea, vomiting (sometimes bloody)
• Stomach pain (possible bleeding in stomach and intestines)

Heart and blood:

• Low blood pressure (shock) and weakness

Kidneys:

• Little to no urine production

Lungs:

• Breathing — difficult
• Breathing — slow
• Wheezing

Nervous system:

• Agitation, confusion, incoherent (not understandable)
• Drowsiness, even coma
• Convulsions
• Dizziness
• Headache (severe)
• Unsteadiness, trouble moving

Skin:

• Rash
• Sweating

Other:

• Chills

What to Expect at the Emergency Room

The health care provider will measure and monitor the person’s vital signs, including temperature, pulse, breathing rate, and blood pressure. Symptoms will be treated as appropriate. The person may receive:

• Activated charcoal
• Airway support, including oxygen, breathing tube through the mouth (intubation), and breathing machine (ventilator)
• Blood and urine tests
• Chest x-ray
• Tube through the mouth into the stomach and small intestine to identify and treat internal bleeding (endoscopy)
• EKG (electrocardiogram, or heart tracing)
• Fluids through a vein (intravenous or IV)
• Laxative
• Medicines to treat symptoms

Outlook (Prognosis)

Recovery is likely with prompt medical treatment, except in very large overdoses. Some people may develop chronic liver or kidney injury.

References

1. White WB, Kloner RA, Angiolillo DJ, Davidson MH. Cardiorenal Safety of OTC Analgesics. Journal of Cardiovascular Pharmacology and Therapeutics. 2018;23(2):103-118. doi:10.1177/1074248417751070. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5808827/
2. Brune K, Patrignani P. New insights into the use of currently available non-steroidal anti-inflammatory drugs. J Pain Res. 2015;8:105–118 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4346004/
3. FitzGerald GA. COX-2 and beyond: approaches to prostaglandin inhibition in human disease. Nat Rev Drug Discov. 2003;2(11):879–890 https://www.nature.com/articles/nrd1225
4. Brune K, Patrignani P. New insights into the use of currently available non-steroidal anti-inflammatory drugs. Journal of Pain Research. 2015;8:105-118. doi:10.2147/JPR.S75160. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4346004/
5. Stockton, D.L. and A.S. Paller. J Am Acad Dermatol 23 (1):87-103; 1990
6. J Toxicol Clin Toxicol 2003;41(4):551-2
7. Weibert RT, Townsend RJ, Kaiser DG et al. Lack of ibuprofen secretion into human milk. Clin Pharm. 1982;1:457-8 https://www.ncbi.nlm.nih.gov/pubmed/7184678
8. Townsend RJ, Benedetti TJ, Erickson SH et al. Excretion of ibuprofen into breast milk. Am J Obstet Gynecol. 1984;149:184-6 https://www.ajog.org/article/0002-9378(84)90195-9/pdf
9. Walter K, Dilger C. Ibuprofen in human milk. Br J Clin Pharmacol. 1997;44:211-2
10. Rigourd V, de Villepin B, Amirouche A et al. Ibuprofen concentrations in human mature milk-First data about pharmacokinetics study in breast milk with AOR-10127 “Antalait” study. Ther Drug Monit. 2014;36:590-6 https://www.ncbi.nlm.nih.gov/pubmed/24695355
11. Hardman, J.G., L.E. Limbird, P.B. Molinoff, R.W. Ruddon, A.G. Goodman (eds.). Goodman and Gilman’s The Pharmacological Basis of Therapeutics. 9th ed. New York, NY: McGraw-Hill, 1996., p. 712
12. GUIDRY JB ET AL; JAMA 242 (JUL 6): 68; 1979 https://jamanetwork.com/journals/jama/article-abstract/365628
13. WARRINGTON SJ ET AL; RHEUMATOLOGY 7 (NEW TRENDS OSTEOARTHRITIS): 107;1982
14. COURT H ET AL; HUM TOXICOL 2 (2): 381; 1983 https://www.ncbi.nlm.nih.gov/pubmed/6862484
15. Lortholary A et al; Rev Med Interne 11 (3): 243-4; 1990 https://www.ncbi.nlm.nih.gov/pubmed/2096424
16. Grant, W.M. Toxicology of the Eye. 3rd ed. Springfield, IL: Charles C. Thomas Publisher, 1986., p. 506
17. Young, L.Y., M.A. Koda-Kimble (eds.). Applied Therapeutics. The Clinical Use of Drugs. 6th ed. Vancouver, WA., Applied Therapeutics, Inc. 1995., p. 29-12
18. Head JE et al; Bone 29 (5): 437-41; 2001 https://www.ncbi.nlm.nih.gov/pubmed/11704495

What is Aleve

Aleve is a non-steroidal anti-inflammatory drug (NSAID) containing the active ingredient Naproxen. Aleve (naproxen) is a medicine that reduces inflammation and pain in joints and muscles. Aleve (naproxen) is used to treat diseases of joints, such as rheumatoid arthritis, osteoarthritis, and gout. Aleve (naproxen) works by inhibiting the enzymes Cyclooxygenase 1 (COX-1) and Cyclooxygenase 2 (COX-2) by reducing hormones prostaglandin that cause inflammation, fever and pain in the body ¹. Cyclooxygenase 1 (COX-1) is constitutively active and is expressed in most tissues, including kidney, lung, stomach, duodenum, jejunum, ileum, colon, and cecum. Cyclooxygenase 1 (COX-1) functions in gastric cytoprotection, vascular homeostasis, platelet aggregation, and maintenance of normal kidney function ². Cyclooxygenase 2 (COX-2) is an inducible enzyme expressed in the brain, kidney, and possibly in the female reproductive system ². Cyclooxygenase 2 (COX-2) expression is increased during states of inflammation ³. Cyclooxygenase 2 (COX-2) is a key source of prostacyclin (PGI₂) and is cardioprotective in ischemia–reperfusion injury ³. Aleve (naproxen) analgesic activity is primarily (although not exclusively) associated with inhibition of COX-2, while different side effects result from the inhibition of COX-1 and COX-2 ⁴.

Aleve (naproxen) is also used for period pain (dysmenorrhea) and muscle and bone disorders, such as back pain and sprains and strains.

Aleve (naproxen) is available on prescription as tablets or as a liquid that you drink. You can buy it without a prescription from a pharmacy for period pain.

Aleve (naproxen) can only be taken by children when it’s prescribed for them.

Prescription Aleve (naproxen) is used to:

• relieve pain, tenderness, swelling, and stiffness caused by osteoarthritis (arthritis caused by a breakdown of the lining of the joints), rheumatoid arthritis (arthritis caused by swelling of the lining of the joints), juvenile arthritis (a form of joint disease in children), and ankylosing spondylitis (arthritis that mainly affects the spine).

Prescription Aleve (naproxen) tablets, extended-release tablets, and suspension are also used to relieve shoulder pain caused by bursitis (inflammation of a fluid-filled sac in the shoulder joint), tendinitis (inflammation of the tissue that connects muscle to bone), gouty arthritis (attacks of joint pain caused by a build-up of certain substances in the joints), and pain from other causes, including menstrual pain (pain that happens before or during a menstrual period).

Nonprescription Aleve (naproxen) is used to reduce fever and to relieve mild pain from headaches, muscle aches, arthritis, menstrual periods, the common cold, toothaches, and backaches.

Key facts:

• Take Aleve (naproxen) tablets with or just after a meal or snack.
• Take the lowest dose of Aleve (naproxen) for the shortest time to control your symptoms.
• Aleve (naproxen) may impair fertility and is not recommended in women attempting to conceive.
• Aleve (naproxen) may affect your developing baby if you take it during pregnancy. However, if it is necessary for you to take Aleve (naproxen), your doctor will discuss the risks and benefits of taking this medicine during pregnancy.
• If you take Aleve (naproxen) while you have an infection, the Aleve may hide some of the signs of an infection (e.g. pain, fever). This may make you think, mistakenly, that you are better or that it is not serious.
• You plan to have surgery or you are being prepared for coronary bypass surgery, Aleve (naproxen) can prolong bleeding.
• Aleve (naproxen) use in People Over 65 years: Older people may be at more risk of developing stomach ulcers and hence your doctor may prescribe a lower dose.
• Be careful driving or operating machinery until you know how Aleve (naproxen) affects you. Aleve (naproxen) may cause dizziness or light-headedness in some people. Make sure you know how you react to Aleve (naproxen) before you drive a car, operate machinery, or do anything else that could be dangerous if you are dizzy or light-headed. If this occurs do not drive. If you drink alcohol, dizziness or light-headedness may be worse.
• The most common side effects of Aleve (naproxen) are confusion, headache, ringing in the ears, changes in vision, tiredness, drowsiness, dizziness and rashes.

When will I feel better?

You should start to feel better 1 hour after taking Aleve (naproxen). However, it might take up to 3 days for Aleve (naproxen) to work properly if you take it regularly twice a day.

How long will I take Aleve for?

Depending on why you’re taking Aleve (naproxen), you may only need to take it for a short time. For example, if you have a sore back or period pain, you may only need to take Aleve (naproxen) for a day or two.

You may need to take it for longer if you have a long-term condition, such as rheumatoid arthritis.

If you need to take Aleve (naproxen) for a long time, your doctor may prescribe a medicine to protect your stomach from side effects.

It’s best to take the lowest dose of Aleve (naproxen) for the shortest time to control your symptoms.

Talk to your doctor if you’re unsure how long you need to take Aleve (naproxen) for.

Can I take Aleve for a long time?

Aleve (naproxen) can cause an ulcer in your stomach or gut if you take it for a long time or in big doses.

There’s also a small risk that people taking very big doses (at least twice the usual daily dose) for a long time may get heart failure or kidney failure.

It’s best to take the lowest dose that works for the shortest possible time.

If you need to take Aleve (naproxen) very often or you’re taking a big dose, talk to your doctor about your pain.

Are there other painkillers I can try?

The type of painkiller that’s best depends on what type of pain you have and the cause of your pain.

If Aleve (naproxen) doesn’t get rid of your pain, you can try painkillers that you can buy from shops and pharmacies, such as acetaminophen or co-codamol (acetaminophen combined with low-dose codeine).

If the medicine you buy isn’t controlling your pain, your doctor may recommend another type of treatment to help your pain, such as exercise or physiotherapy. Your doctor may also be able to prescribe a stronger painkiller, such as higher-dose acetaminophen combined with low-dose codeine or codeine (an opioid).

Aleve (naproxen) doesn’t work for some types of pain, such as nerve pain. Your doctor will have to prescribe a different medicine if your pain is related to your nerves.

Why do I need to be careful of stomach ulcers?

Aleve (naproxen) can cause an ulcer in your stomach or gut if you take it for a long time or in big doses, or if you’re elderly or in poor general health.

• If you think you may have symptoms of a stomach ulcer, stop taking Aleve (naproxen) and contact your doctor.

Your doctor may tell you not to take Aleve (naproxen) if you have a stomach ulcer or if you’ve had one in the past. If you need to take Aleve (naproxen) but you’re at risk of getting a stomach ulcer, your doctor may prescribe another medicine for you to take alongside Aleve (naproxen) to protect your stomach.

The most common symptom of a stomach ulcer is a burning or gnawing pain in the center of the abdomen. However, stomach ulcers aren’t always painful and some people may have other symptoms, such as indigestion, heartburn and feeling sick.

If you’re prone to stomach ulcers or have had one before, take acetaminophen (paracetamol) instead of Aleve (naproxen) as it’s gentler on your stomach.

Can Aleve cause heart failure?

It’s been said that taking anti-inflammatory medicines increases the chances of getting heart failure. However, the risk is very small for most people. The possibility of heart failure is only a problem if you have been taking very big doses (twice the usual daily dose) of Aleve (naproxen) for a long time.

If you find you need to take Aleve (naproxen) very often or you’re taking doses higher than recommended, talk to your doctor about your pain.

Some anti-inflammatory medicines are less risky than others. Your doctor will be able to help you decide which is the best one for you.

Does Aleve cause an irregular heartbeat?

It’s thought some anti-inflammatory medicines, including Aleve (naproxen), can increase the chance of you getting an irregular heartbeat (such as atrial fibrillation or atrial flutter).

However, the chances of getting an irregular heartbeat is small and not enough to recommend people stop taking these medicines.

If you’re prescribed Aleve (naproxen) for a long-term condition, keep taking it and talk to your doctor if you’re worried. If you buy Aleve (naproxen) from a shop, occasional doses or short courses (2 or 3 days) are safe.

Does Aleve cause kidney failure?

Aleve (naproxen) is safe for occasional use when taken as advised by a doctor. If you have problems with your kidney function, talk to your doctor about the best anti-inflammatory to take.

Non-Steroidal Anti-Inflammatory Drugs (or NSAIDs) may cause an increased risk of sudden kidney failure and even progressive kidney damage.

Does Aleve cause hearing loss?

It’s been reported that women taking some anti-inflammatory medicines, including Aleve (naproxen), twice a week for more than a year have a higher chance of losing their hearing.

However, there’s no proof that Aleve (naproxen) and similar anti-inflammatory medicines cause hearing loss.

Hearing loss is common as people get older. There are ways to protect your hearing – for example, limiting your exposure to loud noise, wearing hearing protection in noisy places, and keeping the volume down on personal headphones.

If you find you have to take Aleve (naproxen) several days a week, talk to your doctor about what’s causing your pain and whether there are better ways to manage it.

Will Aleve affect my fertility?

Taking anti-inflammatory medicines, like Aleve (naproxen), in large doses or for a long time can affect ovulation in women. This may make it more difficult to get pregnant.

Don’t take Aleve (naproxen) if you’re trying to get pregnant or you’re having tests for infertility. Acetaminophen (paracetamol) is a better painkiller in these situations.

Will Aleve affect my contraception?

Aleve (naproxen) will not affect contraceptive pills or the morning after pill in women.

Can I drink alcohol with Aleve?

Yes, you can drink alcohol while taking Aleve (naproxen). However, drinking too much alcohol may irritate your stomach and Aleve (naproxen) contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you have 3 or more alcoholic drinks every day while using Aleve (naproxen).

Who can and can’t take Aleve

Aleve (naproxen) can be taken by adults.

Aleve (naproxen) relieves pain and reduces inflammation (swelling, redness and soreness) that may occur in the following:

• different types of arthritis including rheumatoid arthritis, osteoarthritis and ankylosing spondylitis
• muscle and bone injuries such as sprains, strains, low back pain (lumbago), rheumatism and tendonitis, such as tennis elbow
• swelling and pain after setting broken or dislocated bones
• menstrual cramps (period pain)
• headache, including migraines
• following surgery
• dental pain.

Although Aleve (naproxen) can relieve the symptoms of pain and inflammation, it will not cure your condition.

Aleve (naproxen) belongs to a group of medicines called Non-Steroidal Anti-Inflammatory Drugs (or NSAIDs).

Ask your doctor if you have any questions about why this medicine has been prescribed for you.

Your doctor may have prescribed it for another reason.

It can also be taken under medical supervision by children to treat:

• muscle and bone disorders for babies from 1 month
• diseases of the joints for children from 2 years
• period pain – for girls of any age

Aleve (naproxen) isn’t suitable for certain people. Tell your doctor or pharmacist if you:

• have had an allergic reaction to Aleve (naproxen) or any other medicines in the past
• are allergic to aspirin or other anti-inflammatory medicines (like ibuprofen), or if you’ve developed signs of asthma (wheezing), runny nose, swelling of the skin (angioedema) or a skin rash
• have or have had stomach ulcers, bleeding in the stomach or intestines, or a hole in your stomach
• have high blood pressure
• have severe liver, kidney, or heart failure
• have Crohn’s disease or ulcerative colitis
• have lupus
• have a blood clotting disorder
• are pregnant, planning to become pregnant, or breastfeeding
• Do NOT give Aleve (naproxen) to a child under 2 years of age. The safety and effectiveness in children under 2 years of age has not been established.

When you must not be given Aleve

Do NOT take Aleve (naproxen) if you have an allergy to:

• Aleve (naproxen) or any of the ingredients listed on the medicine leaflet
• aspirin or any other non-steroidal anti-inflammatory drug (NSAID) medicine.

Many medicines used to treat headache, period pain and other aches and pains contain aspirin or non-steroidal anti-inflammatory drug (NSAID) medicines. If you are not sure if you are taking any of these medicines, ask your pharmacist.

Some of the symptoms of an allergic reaction may include:

• asthma, wheezing or shortness of breath
• swelling of the face, lips or tongue which may cause difficulty in swallowing or breathing
• hives, itching or skin rash
• fainting.

If you are allergic to aspirin or non-steroidal anti-inflammatory drug (NSAID) medicines and take Aleve (naproxen) Suspension, these symptoms may be severe.

Do NOT take Aleve (naproxen) if:

• you are vomiting blood or material that looks like coffee grounds
• you are bleeding from the rectum (back passage), have black sticky bowel motions (stools) or bloody diarrhoea
• you have a peptic ulcer (i.e. stomach or duodenal ulcer), or have had peptic ulcers before
• you are taking other medicines which contain Naproxen or Naproxen Sodium (e.g. Naprogesic, Inza, Anaprox, EC-Naprosyn, Flanax Pain Reliever, Midol Extended Relief, Naprelan 375, Naprosyn, Anaprox, Anaprox-DS, Naprelan 500, Naproxen Sodium DS, Aleve Caplet, Aleve Gelcap, Aflaxen, Aleve Easy Open Arthritis, Leader Naproxen Sodium, Comfort Pac with Naproxen, Naprelan 750, Naprelan Dose Card)
• you have severe heart failure.

Pregnancy and breastfeeding

Aleve (naproxen) isn’t normally recommended in pregnancy – especially if you’re 30 or more weeks – unless it’s prescribed by a doctor. This is because there might be a link between taking Aleve (naproxen) in pregnancy and some birth defects, in particular damage to the baby’s heart and blood vessels.

There may also be a link between taking Aleve (naproxen) in early pregnancy and miscarriage.

Talk to your doctor about the benefits and possible harms of taking Aleve (naproxen). It will depend on how many weeks pregnant you are and the reason you need to take the medicine. There may be other treatments that are safer for you.

Acetaminophen (Tylenol) is usually recommended as the first choice of painkiller for pregnant women.

Aleve (naproxen) and breastfeeding

Aleve (naproxen) isn’t usually recommended during breastfeeding. Aleve (naproxen) passes into breast milk. The effect on the baby is not known.

Other anti-inflammatory medicines, such as ibuprofen (e.g., Advil or Motrin), are safer.

However, if your baby is premature, had a low birth weight, or has an underlying medical condition, talk to your doctor before taking any painkillers.

Cautions with other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket, health food shop, naturopath or herbalist.

There are some medicines that interfere with the way Aleve (naproxen) works. Tell your doctor if you’re taking:

• other anti-inflammatory medicines, such as aspirin or ibuprofen (e.g., Advil or Motrin)
• medicines that thin the blood to prevent blood clots, such as warfarin or rivaroxaban
• heparin, a medicine used to prevent blood clots
• steroids, such as prednisolone
• water tablets, such as furosemide
• medicines used to treat high blood pressure including ACE inhibitors, angiotensin receptor antagonists and beta-blockers
• antidepressants, such as citalopram
• medicine used to treat rheumatoid arthritis and some cancers, such as methotrexate
• antacids, medicines used to treat indigestion and heartburn
• aspirin, salicylates or other NSAID medicines
• cholestyramine, a medicine used to treat high cholesterol levels
• diuretics, also called fluid or water tablets
• lithium, a medicine used to treat some types of depression
• probenecid, a medicine used to treat gout
• phenytoin, a medicine used to treat epilepsy
• sucralfate, a medicine used to treat and prevent stomach ulcers
• certain antibiotics called sulfonamides/quinolones
• some medicines used to treat diabetes
• sodium bicarbonate, a medicine used to treat stomach upset or ulcers
• steroids, medicines used to treat inflammation
• serotonin reuptake inhibitors, also known as SSRIs, medicines used to treat some types of depression
• zidovudine, a medicine used to treat HIV infection.

Tell your doctor and pharmacist if you’re taking any other medicines, including herbal remedies, vitamins or supplements.

These medicines may be affected by Aleve (naproxen) or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.

Your doctor has more information on medicines to be careful with or avoid while being given this medicine.

Ask your doctor or pharmacist if you are not sure about this list of medicines.

Can you take ibuprofen with aleve

No. Both ibuprofen and Aleve (naproxen) come from a class of drug known as non-steroidal anti-inflammatory drugs (NSAIDs). By taking both ibuprofen and Aleve (naproxen) together you’re increasing your chances of getting side effects.

Can you take tylenol with aleve

Yes, but on the condition that you’ve been directed to do so by your doctor. Do not take Aleve (naproxen) and Tylenol (acetaminophen) together, though. Instead, if you’ve been given Tylenol (acetaminophen) to take and you’re still feverish or in pain when the next dose is due, you could try Aleve (naproxen) instead.

Tylenol contains the active ingredient acetaminophen (paracetamol) that works differently to Aleve (naproxen).

Aleve (naproxen) is better for reducing inflammation (redness and swelling), including teething and toothache.

Whereas Tylenol (acetaminophen) is usually best for most types of pain, including headache and stomach ache.

Tylenol (acetaminophen) and Aleve (naproxen) are similar strengths, but they work in different ways. So Tylenol (acetaminophen) is better for some types of pain than Aleve (naproxen).

Don’t take more than the maximum daily dose of either medicine. See your doctor if you’ve tried both Aleve (naproxen) and Tylenol (acetaminophen) and they haven’t helped.

Aleve cold and sinus

Aleve-D Sinus & Cold Caplets

Available behind the pharmacy counter without a prescription.

Active ingredients (in each caplet) ⁵:

1. Naproxen sodium 220 mg (naproxen 200 mg) for pain reliever/fever reducer
2. Pseudoephedrine HCl 120 mg, extended-release as nasal decongestant

Inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, talc, titanium dioxide

Other information

• each caplet contains: sodium 22 mg
• store at 20-25 °C (68-77 °F)
• store in a dry place

Aleve cold and sinus caplets Uses

Temporarily relieves these cold, sinus, and flu symptoms:

• sinus pressure
• minor body aches and pains
• headache
• nasal and sinus congestion (promotes sinus drainage and restores freer breathing through the nose)
• fever

Directions of use:

• do NOT take more than directed
• the smallest effective dose should be used
• swallow whole; do not crush or chew
• drink a full glass of water with each dose
  • Adults and children 12 years and older: 1 caplet every 12 hours
  • Do not take more than 2 caplets in 24 hours
  • Children under 12 years: do NOT use, except under the advice and supervision of a doctor.

Aleve-D Sinus & Cold Caplets Warnings

Allergy alert

Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

• hives
• facial swelling
• asthma (wheezing)
• shock
• skin reddening
• rash
• blisters

If an allergic reaction occurs, stop use and seek medical help right away.

Stomach bleeding warning

This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:

• are age 60 or older
• have had stomach ulcers or bleeding problems
• take a blood thinning (anticoagulant) or steroid drug
• take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
• have 3 or more alcoholic drinks every day while using this product
• take more or for a longer time than directed

Do NOT use

• if you have ever had an allergic reaction to any other pain reliever/fever reducer
• right before or after heart surgery
• if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
• in children under 12 years of age

Ask a doctor before use if:

• the stomach bleeding warning applies to you
• you have a history of stomach problems, such as heartburn
• you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
• you are taking a diuretic
• you have problems or serious side effects from taking pain relievers or fever reducers
• you have:
  • asthma
  • diabetes
  • thyroid disease
  • trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are:

• under a doctor’s care for any serious condition
• taking any other drug

When using this product:

• take with food or milk if stomach upset occurs
• the risk of heart attack or stroke may increase if you use more than directed or for longer than directed

Stop use and ask a doctor if:

● you experience any of the following signs of stomach bleeding:
● feel faint ● vomit blood ● have bloody or black stools
● have stomach pain that does not get better
● redness or swelling is present in the painful area
● any new symptoms appear
● fever gets worse or lasts more than 3 days
● you have difficulty swallowing or the caplet feels stuck in your throat
● you get nervous, dizzy, or sleepless
● nasal congestion lasts more than 7 days

If pregnant or breast-feeding

Ask a health professional before use. It is especially important not to use naproxen sodium during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Aleve vs Advil

Advil is a brand of tablets or capsules containing the active ingredient Ibuprofen, like Aleve (naproxen), Advil (ibuprofen) is also a non-steroidal anti-inflammatory drug (NSAID). You can buy it without a prescription from a grocery store or a pharmacy.

Some other common non-steroidal anti-inflammatory drugs (NSAIDs) are:

• aspirin
• celecoxib
• diclofenac
• indomethacin
• meloxicam

There are many others. You can check whether a medicine you’re taking is an NSAID, or contains an NSAID by asking your pharmacist.

Advil (ibuprofen) is used to temporarily relief of acute pain where inflammation is present such as back, neck and muscle pain. Temporary relief of headache, migraine headache, tension headache, period pain, dental pain, arthritis pain, rheumatic pain, tennis elbow pain, sore throat, sinus pain, and pain associated with the common cold and flu. Advil (ibuprofen) is also used to relieve fever.

Advil (ibuprofen) is used to reduce pain and inflammation (redness and swelling) in conditions such as osteoarthritis and rheumatoid arthritis. It is also used in muscle and bone injuries such as sprains, strains, low back pain, rheumatism and tendonitis. Moreover, like Aleve, Advil does not cure these conditions.

Advil can also be used to relieve period pain, dental pain and post-surgery pain.

Swallow Advil (ibuprofen) whole with a full glass of water or milk, preferably with or straight after food.

You should seek medical advice in relation to medicines and use only as directed by a healthcare professional. Always read the label. If symptoms persist see your healthcare professional. HealthJade medicines information is not intended for use in an emergency. This information is not intended to substitute medical advice, diagnosis or treatment and should not be exclusively relied on to manage or diagnose a medical condition. Please refer to our terms and conditions. If you are suffering an acute illness, overdose, or emergency condition, call your local emergency number and ask for an ambulance.

How and when to take Aleve

Always take your Aleve (naproxen) tablets with or just after a meal so you don’t get an upset stomach.

As a general rule in adults, the dose to treat:

• diseases of joints is 500mg to 1000mg a day in 1 or 2 doses
• muscle, bone disorders and painful periods is 500mg at first, then 250mg every 6 to 8 hours as required
• attacks of gout is 750mg, then 250mg every 8 hours until the attack has passed

Do NOT take more than 3 tablets in 24 hours.

Doses are usually lower for elderly people and people with heart, liver or kidney problems.

The doctor will use your child’s weight to work out the right dose.

If you get Aleve (naproxen) on prescription, the dose depends on the reason why you’re taking it, your age, how well your liver and kidneys work, and how well it helps your symptoms.

If you buy Aleve (naproxen) from a pharmacy for painful menstrual periods:

• on the first day – take 2 tablets when the pain starts, then after 6 to 8 hours one more tablet that day if you need to
• on the second and following days – take one tablet every 6 to 8 hours if needed

How to take Aleve

Use Aleve (naproxen) exactly as directed on the label, or as prescribed by your doctor. Do not take this medicine in larger amounts or for longer than recommended. Use the lowest dose that is effective in treating your condition.

Aleve (naproxen) on prescription comes as 2 different tablets – effervescent and gastro-resistant tablets.

Effervescent tablets are dissolved in water before you take them.

Gastro-resistant tablets have a coating to protect them from being broken down by the acid in your stomach. Instead, the medicine is released further down the gut in your intestine.

If you take gastro-resistant tablets, swallow them whole with or after food. Don’t crush or chew them.

If you take effervescent tablets, dissolve 1 to 2 tablets in a glass (150ml) of water and drink.

Doses of 3 tablets should be dissolved in 300ml. To make sure there is no medicine left, rinse the empty glass with a small amount of water and drink it. Take with or after food.

What if I forget to take it?

Take your forgotten dose as soon as you remember, unless it’s nearly time for your next dose. Don’t take a double dose to make up for a forgotten dose.

If you forget doses often, it may help to set an alarm to remind you. You could also ask your pharmacist for advice on other ways to help you remember to take your medicine.

What if I take too much?

If you take too many Aleve (naproxen) tablets by accident, you’re more likely to get some of the common side effects. Contact your doctor straight away.

Aleve dosage

Take Aleve (naproxen) during or immediately after food with a full glass of water or milk. This may help reduce the possibility of an upset stomach.

Sprains, strains and period pain

• The recommended dose is 500 mg, followed by 250 mg every 6 to 8 hours, as needed. Total daily dose is 1250 mg.

Migraine Headache

• The recommended dose is 750 mg taken at the first sign of a migraine. An additional dose of 250 mg to 500 mg can be taken at least an hour after the initial dose, if required. The total daily dose should not exceed 1250 mg.

Arthritis

• The recommended dose is 375 mg to 1000 mg a day in two divided doses.

Juvenile Rheumatoid Arthritis

• The recommended dose for children 5 years and above is 10 mg/kg body weight given in 2 equal divided doses (i.e. 5 mg/kg body weight twice a day).

Aleve (naproxen) is also sometimes used to treat Paget’s disease of bone (a condition in which the bones become abnormally thick, fragile, and misshapen) and Bartter syndrome (a condition in which the body does not absorb enough potassium, causing muscle cramping and weakness and other symptoms). Talk to your doctor about the risks of using this medication for your condition.

How many Aleve can I take?

Take one tablet, caplet, gelcap or liquid gel every 8 to 12 hours while symptoms last. For the first dose, you may take 2 pills within the first hour.

Do not exceed more than 2 tablets, caplets, gelcaps or liquid gels in 12 hours, and do not exceed 3 tablets, caplets, gelcaps or liquid gels in 24 hours. The smallest effective dose should be used. Drink a full glass of water with each dose.

Do not take for more than 10 consecutive days for pain or 3 days for fever, unless directed by a doctor.

What’s the dose for children under 12?

Do NOT give this product to children under age 12, except under the advice and supervision of a doctor.

For how many days can I take Aleve?

Do not take for more than 10 consecutive days for pain or 3 days for fever unless directed by a doctor.

Aleve side effects

Like all medicines, Aleve (naproxen) can cause side effects although not everyone gets them.

Common side effects

Common side effects of Aleve (naproxen) happen in more than 1 in 100 people and include:

• confusion
• headache
• buzzing or ringing in the ears
• changes in vision
• tiredness and feeling sleepy
• dizziness
• rashes
• stomach upset including nausea (feeling sick), heartburn, indigestion, cramps
• constipation, diarrhea, pain in the stomach
• loss of appetite
• dizziness, light-headedness
• drowsiness, sleepiness
• feeling thirsty
• aching muscles, muscle tenderness or weakness, not caused by exercise.

Less common side effects of Aleve

Less common side effects of Aleve (naproxen) happen in more than 1 in 1,000 people. They include:

• depression
• irregular heartbeat (palpitations)
• abnormal dreams
• forgetfulness
• difficulty concentrating
• sensitivity of the skin to light (may cause blistering)
• difficulty sleeping

Rarely, Aleve (naproxen) can cause some side effects that happen in less than 1 in 1000 people:

• hair loss
• problems with hearing
• inflammation of blood vessels – causing fever, swelling, and generally not feeling well
• asthma getting worse
• muscle weakness and pain
• ulcers on the inner cheeks, gums and tongue

Talk to your doctor or pharmacist if these side effects bother you or don’t go away.

Serious side effects

Tell your doctor straight away or go to the Emergency Department at your nearest hospital if you experience any of the following:

• severe indigestion, heartburn, pains in your stomach, feeling sick or vomiting or diarrhea – these can be signs of an ulcer or inflammation in the stomach or gut
• vomiting blood or dark particles that look like coffee grounds, blood in your poo, or black, tarry-looking poo these could be signs of bleeding and perforation of the stomach or gut
• frequent sore throat, nose bleeds, and infections these can be signs of abnormalities in your blood cells, known as agranulocytosis
• fainting, chest pain, or breathlessness – these can be signs of anemia
• fever, feeling sick or vomiting, confusion, headache, neck stiffness and sensitivity to light – these can be signs of aseptic meningitis
• a severe skin rash with flushing, blisters or ulcers – these can be signs of Stevens-Johnson syndrome
• bleeding or bruising more easily than normal, reddish or purplish blotches under the skin
• blood in your pee, a decrease in how much pee is passed, feeling sick or vomiting – these can be signs of kidney damage or infection
• yellowing of the skin or whites of the eyes – these can be signs of jaundice or inflammation of the liver
• irregular, slow heartbeats caused by high levels of potassium in the blood
• fast or irregular heartbeats, also called palpitations
• fever, stomach pain and vomiting – these can be signs of inflammation of the pancreas
• eye problems such as blurred vision
• severe or persistent headache
• difficulty hearing, deafness
• signs of frequent or worrying infections such as fever, severe chills, sore throat or mouth ulcers
• unusual weight gain, swelling of ankles or legs

These are very serious side effects. You may need urgent medical attention or hospitalisation. These side effects are very rare.

This is not a complete list of all possible side effects. Others may occur in some people, and there may be some side effects not yet known.

Tell your doctor if you notice anything else that is making you feel unwell, even if it is not on this list. Ask your doctor or pharmacist if you don’t understand anything in this list.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

Serious allergic reaction

In rare cases, it’s possible to have a serious allergic reaction to Aleve (naproxen). A serious allergic reaction is an emergency. Contact a doctor straight away if you think you or someone around you is having a serious allergic reaction.

The warning signs of a serious allergic reaction are:

• getting a skin rash that may include itchy, red, swollen, blistered or peeling skin
• wheezing
• tightness in the chest or throat
• having trouble breathing or talking
• swelling of the mouth, face, lips, tongue, or throat

These are not all the side effects of Aleve (naproxen). For a full list see the leaflet inside your medicines packet.

How to cope with side effects

What to do about:

• headache – make sure you rest and drink plenty of fluids. Don’t drink too much alcohol. Ask your pharmacist to recommend a painkiller. Headaches should usually go away after the first week of taking Aleve (naproxen). Talk to your doctor if they last longer than a week or are severe.
• feeling sleepy, tired or dizzy – as your body gets used to Aleve (naproxen), these side effects should wear off.
• changes in vision – don’t drive for a week.
• dizziness – if Aleve (naproxen) makes you feel dizzy, stop what you’re doing and sit or lie down until you feel better.

Human Toxicity Reports

Most cases of naproxen overdosage have been reported in adults ⁶. Adverse gastrointestinal effects (e.g., heartburn, vomiting) and seizures usually occur in these patients; drowsiness and prolongation of clotting time also may occur. The incidence of adverse effects in adults may differ from those in children since rash and prolonged bleeding time appear to occur more frequently in children while other reactions occur more frequently in adults; the incidence of adverse gastrointestinal and CNS (central nervous system) effects are similar ⁶. Toxic epidermal necrolysis, erythema multiforme, Stevens-Johnson syndrome, urticaria, alopecia, erythema nodosum, fixed drug eruption, lichen planus, and pustular reaction have been reported during postmarketing experience ⁷.

Pseudoporphyria, a cutaneous disorder characterized by skin fragility, vesiculation, and scarring, has been reported as a side effect of naproxen therapy in children with juvenile rheumatoid arthritis ⁸. The results of a 6-month prospective study to determine the prevalence of pseudoporphyria in the juvenile rheumatoid arthritis population are presented. All the patients with pseudoporphyria had received naproxen for > or = 4 weeks at the time of the study. Of the patients treated with naproxen, 12% (9/74) developed this complication ⁸. No patient had significant elevation of free erythrocyte protoporphyrin, excluding the diagnosis of true erythropoietic protoporphyria. The study authors conclude that pseudoporphyria is a common side effect of naproxen therapy in children with juvenile rheumatoid arthritis, even in geographic areas without high sun exposure ⁸. Because of the risk of facial scarring with pseudoporphyria, physicians and parents of children with juvenile rheumatoid arthritis should be aware of this complication.

Severe, sometimes fatal, toxicity has occurred following administration of a nonsteroidal anti-inflammatory drug (NSAID) concomitantly with methotrexate (principally high-dose therapy) in patients with various malignant neoplasms or rheumatoid arthritis ⁹. The toxicity was associated with elevated and prolonged blood concentration of methotrexate. The exact mechanism of the interaction remains to be established, but it has been suggested that nonsteroidal anti-inflammatory drugs (NSAIDs) may inhibit renal elimination of methotrexate, possibly by decreasing renal perfusion via inhibition of renal prostaglandin synthesis or by competing for renal elimination ⁹. Naproxen and methotrexate should be administered concomitantly with caution. Pending further accumulation of data, some clinicians recommend that nonsteroidal anti-inflammatory drugs be avoided in patients receiving methotrexate ⁹.

Jaundice (including cholestatic jaundice which cleared promptly when naproxen was discontinued) and fatal hepatitis have been reported rarely in patients receiving naproxen ⁷. Abnormal liver function test results, including mild and generally transient increases in serum alkaline phosphatase, have occurred in some patients.

A case report of a pre-term infant who developed severe hyponatremia and water retention associated with the ingestion of an overdose of the non-steroid anti-inflammatory drug naproxen eight hours before delivery is reported ¹⁰. Recovery was complete and subsequent development unimpaired.

The development of acute renal failure and interstitial nephritis due to therapeutic doses of non-steroidal anti-inflammatory drugs (NSAIDs) has been documented repeatedly in adult patients but is rare in children ¹¹. This study report the occurrence of this complication in a child. Acute renal failure and hyperkalemia developed in a 2-year-old boy with juvenile rheumatoid arthritis after one month of naproxen sodium therapy ¹¹. The evidence of renal toxic effects became manifest after an episode of dehydration. A percutaneous renal biopsy specimen revealed interstitial nephritis. The patient recovered promptly after withdrawal of the drug ¹¹.

The occurrence of severe acute renal failure in a 10-year-old girl with juvenile rheumatoid arthritis after 1 month of naproxen therapy is reported ¹². Renal biopsy showed severe acute interstitial nephritis. The patient recovered completely after discontinuation of naproxen and administration of methylprednisolone ¹².

Renal failure occurred in a 14-year-old girl with peripheral arthritis associated with inflammatory bowel disease while she was being treated with naproxen ¹³. She had previously received aspirin and tolmetin sodium and had no complications. A renal biopsy showed a severe tubulointerstitial nephritis. Although her renal function improved somewhat with corticosteroid treatment, it worsened when the steroids were discontinued ¹³.

A case of a 3,790-g term neonate who developed persistent pulmonary hypertension after birth with a closed ductus arteriosus is reported ¹⁴. The mother admitted to taking naproxen sodium immediately prior to the birth of the infant. The course of illness was progressively better on conservative management. Like indomethacin, other nonsteroid anti-inflammatory drugs (NSAIDs) can also cause premature closure of fetal ductus arteriosus, pulmonary hypertension, and life-threatening problems to the neonate ¹⁴.

Pulmonary infiltrates developed in three middle-aged women while receiving naproxen sodium ¹⁵. Weakness, fatigue, cough, low-grade fever, and eosinophilia in blood and/or sputum were common to all. All symptoms and findings resolved within a few days after discontinuing naproxen therapy in two cases and with use of corticosteroids (prednisone) in one case. A hypersensitivity reaction due to naproxen seemed to be the likely cause ¹⁵.

A 12 year old boy developed scars at light-exposed areas following long-term therapy with naproxen for rheumatoid arthritis ¹⁶. Erythrocyte and urine porphyrin levels were not increased, and there was no evidence of increased photosensitivity. Pseudoporphyria is reported in 10-20% of those treated with naproxen for > 4 weeks ¹⁶. As compared to other nonsteroidal anti-inflammatory agents, the specific risk for naproxen is increased about 6 fold ¹⁶. While the underlying abnormality has not been elucidated, formation of phototoxic metabolites in a subgroup of genetically predisposed individuals has been suggested as the most likely mechanism. Both dermatologists and rheumatologists should be aware of the risk of naproxen-induced pseudoporphyria and discontinue therapy early in order to avoid scar formation in light-exposed areas.

Transient prolongation of the prothrombin time (bleeding time) was observed in the setting of a 10 g overdose of naproxen ¹⁷. The patient reported was previously healthy, without chronic liver disease, bleeding disorders, or malnutrition. The most likely mechanism for this effect is direct inhibition of the synthesis of vitamin-K-dependent clotting factors, possibly via production of “abnormal” prothrombin.

A case report of a 39 yr old man who developed dyspnea and periorbital edema following a dosage increase in naproxen after he was previously stabilized on the drug for approximately 1 yr is reported ¹⁸. The patient had been taking oral naproxen 375 mg 3 times daily for back pain. He reported mild shortness of breath and hoarseness after taking the first dose of naproxen, but the reaction subsided and he continued treatment without further adverse effects. After approximately 1 yr, the patient began experiencing increased back pain and his physician increased the naproxen dosage to 500 mg 3 times daily. Within an hr of ingesting the 500 mg dose, the patient developed dyspnea, shortness of breath, hoarseness, and difficulty swallowing. Upon arrival at the emergency room, he was noted to have bilateral periorbital edema. He was treated with subcutaneous epinephrine, parenteral methylprednisolone, and oral diphenhydramine with adequate response. Naproxen therapy was discontinued and the patient was discharged the following day ¹⁸.

Aleve (naproxen) overdose

Symptoms of Aleve (naproxen) overdose include:

• Agitation, confusion, incoherence (the person is not understandable)
• Blurred vision
• Coma
• Convulsions (seizures)
• Diarrhea
• Dizziness, unsteadiness, movement problems
• Drowsiness
• Headache — severe
• Heartburn, stomach pain (possible bleeding in the stomach and intestines)
• Nausea, vomiting
• Rash
• Ringing in the ears
• Slow, labored breathing, wheezing

Your local poison center can be reached directly by calling the national toll-free Poison Help hotline (1-800-222-1222) from anywhere in the United States. This hotline number will let you talk to experts in poisoning. They will give you further instructions.

This is a free and confidential service. You should call if you have any questions about poisoning or poison prevention. You can call 24 hours a day, 7 days a week.

What to Expect at the Emergency Room

The health care provider will measure and monitor the person’s vital signs, including temperature, pulse, breathing rate, and blood pressure. Symptoms will be treated as appropriate. The person may receive:

• Activated charcoal
• Blood and urine tests
• Fluids through a vein (IV)
• Laxatives
• Medicines to treat symptoms

In rare, serious cases, more treatments may be needed. Most people will be discharged from the emergency department after being observed for a period of time.

Outlook (Prognosis)

Recovery is likely.

References

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