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

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

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

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

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

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

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

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

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.

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.

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. http://labeling.bayercare.com/omr/online/aleve-D-sinus-cold-caplets.pdf
6. American Society of Health System Pharmacists; AHFS Drug Information 2009. Bethesda, MD. (2009), p. 2169
7. American Society of Health System Pharmacists; AHFS Drug Information 2009. Bethesda, MD. (2009), p. 2166
8. Lang BA, Finlayson LA; J Pediatr 124 (4): 639-42 (1994). Available from, as of June 1, 2009 https://www.ncbi.nlm.nih.gov/pubmed/8151484
9. American Society of Health System Pharmacists; AHFS Drug Information 2009. Bethesda, MD. (2009), p. 2168
10. Alun-Jones E, Williams J; J Toxicol Clin Toxicol 24 (3): 257-60 (1986). Available from, as of June 1, 2009 https://www.ncbi.nlm.nih.gov/pubmed/3723650
11. Ray PE, Rigolizzo D; Am J Dis Child 142 (5): 524-5 (1988). https://www.ncbi.nlm.nih.gov/pubmed/3358393
12. Becker-Cohen R, Frishberg Y; Eur J Pediatr 160 (5): 293-5 (2001). https://www.ncbi.nlm.nih.gov/pubmed/11388597
13. Laxer RM et al; Pediatrics 80 (6): 904-8 (1987). Available from, as of June 1, 2009 http://pediatrics.aappublications.org/content/80/6/904.long
14. Talati AJ et al; Am J Perinatol 17 (2): 69-71(2000). https://www.ncbi.nlm.nih.gov/pubmed/11023164
15. Buscaglia AJ et al; JAMA 251 (1): 65-6 (1984). Available from, as of June 1, 2009 https://jamanetwork.com/journals/jama/article-abstract/390882
16. Maerker JM et al; Hautarzt 52 (11): 1026-9 (2001). https://www.ncbi.nlm.nih.gov/pubmed/11757457
17. Waugh PK, Keatinge DW; Drug Intell Clin Pharm 17 (7-8): 549-50 (1983). https://www.ncbi.nlm.nih.gov/pubmed/6872850
18. Briscoe-Dwyer L Etzel JV; Pharmacother 28 (9): 1110; 1994

What is Zyrtec

Zyrtec is an antihistamine medicine that relieves the symptoms of allergies by blocking the effects of the chemical histamine in your body. 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. 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 ¹. 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 ¹. 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.

When you come into contact with something you’re allergic to, such as pollen, animal hair or fur, house dust or insect bites and stings, your body produces a chemical called histamine.

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.

Zyrtec (cetirizine) blocks the effects of histamine and reduces these symptoms.

Key facts:

• It’s usual to take Zyrtec (cetirizine) once a day. Children sometimes take it twice a day.
• Zyrtec (cetirizine) is classed as a non-drowsy antihistamine, but some people still find it makes them feel quite sleepy.
• Common side effects include headache, dry mouth, feeling sick, dizziness, tummy pain and diarrhea.
• It’s best not to drink alcohol while you’re taking Zyrtec (cetirizine) as it can make you feel sleepy.
• Cetirizine is sold under the trade names Benadryl Allergy, Piriteze, Zirtec, Zyrtec, and Reactine.

Zyrtec (cetirizine) is available on prescription. You can also buy it from pharmacies and supermarkets.

Zyrtec (cetirizine) comes as tablets, capsules and as a liquid that you swallow.

Despite Zyrtec (cetirizine) is being marketed as a non-drowsy antihistamine, it may still impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Drinking alcohol can increase certain side effects of Zyrtec.

Tell your doctor if you regularly use other medicines that make you sleepy (such as other cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by Zyrtec. Call your doctor if your symptoms do not improve, if they get worse, or if you also have a fever.

How long does it take for zyrtec to work?

Cetirizine starts to work within 30 – 60 minutes after being taken. You should start to feel better within an hour.

How long should I take Zyrtec (cetirizine) for?

It depends on why you’re taking Zyrtec (cetirizine).

You may only need to take it for a short time or as a one-off dose. For example, if you have a reaction to an insect bite, you may only need to take Zyrtec (cetirizine) for a day or 2.

You may need to take Zyrtec (cetirizine) 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 Zyrtec (cetirizine) for.

Is it safe to take Zyrtec (cetirizine) for a long time?

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

Can I drink alcohol with Zyrtec?

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

Is there any food or drink I need to avoid?

You can eat and drink normally while taking Zyrtec (cetirizine).

Can I drive or ride a bike with Zyrtec?

Zyrtec (cetirizine) 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.

What’s the difference between Zyrtec (cetirizine) and other antihistamines?

Zyrtec (cetirizine) 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.

What’s the difference between Zyrtec (cetirizine) and other non-drowsy antihistamines?

Other non-drowsy antihistamines like Loratadine, Desloratadine, Fexofenadine, Levocetirizine seem to work just as well as Zyrtec (cetirizine).

However, Zyrtec (cetirizine) seems to be more likely to make you feel sleepy than loratadine, desloratadine or fexofenadine.

Can I take Zyrtec with painkillers?

Yes, you can take Zyrtec (cetirizine) together with Tylenol (acetaminophen) or Motrin (ibuprofen).

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 during the day (such as Zyrtec or loratadine), your doctor may advise that you take a sedating antihistamine at night time if the itch is making it difficult to sleep.

Do not take 2 antihistamines together unless recommended by your doctor.

Can I take Zyrtec with other hay fever treatments?

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

Will Zyrtec affect my fertility?

There’s no evidence that Zyrtec (cetirizine) affects male or female fertility.

Will Zyrtec affect my contraception?

Zyrtec (cetirizine) does not affect any type of contraception including the contraceptive pill and the morning after pill.

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.

Who can and can’t take Zyrtec

Zyrtec (cetirizine) tablets and liquid that you buy from pharmacies and supermarkets can be taken by adults and children aged 6 and older.

Children over the age of 2 can also take liquid Zyrtec (cetirizine) for hay fever and skin allergies.

Zyrtec (cetirizine) can also be taken under medical supervision by children aged 1 year and older.

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

• have had an allergic reaction to Zyrtec (cetirizine) or any other medicines in the past
• have an allergy to peanuts or soya
• have an allergy to the food additives, E218 or E216
• have an intolerance to, or cannot absorb, some sugars such as lactose or sorbitol
• have liver or kidney failure
• have epilepsy or another health problem that puts you at risk of fits
• have an illness that means you’re more likely to retain urine
• are booked to have an allergy test – taking Zyrtec (cetirizine) may affect the results, so you might need to stop taking it a few days before the test

Pregnancy and breastfeeding

You can take Zyrtec (cetirizine) while you’re pregnant. However a similar antihistamine called loratadine is normally used first because there’s more information to say that it’s safe.

• Zyrtec (cetirizine) isn’t thought to be harmful during pregnancy, but as very few pregnant women have been studied, it is not possible to be certain.

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

To assess the safety of cetirizine during pregnancy, a prospective observational cohort study with data from 1992 until 2006 was conducted ². Pregnancy outcome was compared between a cohort of pregnant women exposed to cetirizine during the first trimester (n=196) and a control group not exposed to potential teratogens (n=1686). Major birth defects were not more common in the study group than in the control group ². The investigators also compared the crude rate of spontaneous abortions of preterm deliveries and the birth weight of term newborns. This prospective observational study on cetirizine in pregnancy suggests that the use of cetirizine is relatively safe during the first trimester ².

Zyrtec (cetirizine) and breastfeeding

It’s usually safe to take cetrizine if you’re breastfeeding as only small amounts get into breast milk.

However, speak to your doctor before taking Zyrtec (cetirizine) if your baby was premature, had a low birth weight or has other health problems.

What is zyrtec used for

Zyrtec (cetirizine) is used to temporarily relieve the symptoms of hay fever (allergy to pollen, dust, or other substances in the air) and allergy to other substances (such as dust mites, animal dander, cockroaches, and molds). These symptoms include sneezing; runny nose; itchy, red, watery eyes; and itchy nose or throat. Zyrtec (cetirizine) is also used to treat itching and redness caused by hives. However, Zyrtec (cetirizine) does not prevent hives or other allergic skin reactions.

Zyrtec (cetirizine) comes as a tablet, a chewable tablet, an extended release tablet, and a syrup (liquid) to take by mouth. It is usually taken once a day with or without food. Take Zyrtec (cetirizine) at around the same time every day. Follow the directions on the package label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take Zyrtec (cetirizine) exactly as directed. Do not take more or less of it or take it more often than directed on the package label or as recommended by your doctor.

• Do NOT use Zyrtec (cetirizine) to treat hives that are bruised or blistered, that are an unusual color, or that do not itch. Call your doctor if you have these types of hives.

Stop taking Zyrtec (cetirizine) and see 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, see your doctor.

If you are taking Zyrtec (cetirizine) 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 Zyrtec (cetirizine) in place of the epinephrine injector.

Zyrtec (cetirizine) is also available in combination with pseudoephedrine (Sudafed, others). If you are taking the cetirizine and pseudoephedrine combination product, read the information on the package label or ask your doctor or pharmacist for more information.

Zyrtec dosage

Before taking Zyrtec

• tell your doctor and pharmacist if you are allergic to Zyrtec (cetirizine), hydroxyzine (Vistaril), 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: antidepressants, medications for anxiety, medications for mental illness, medications for seizures, other medications for cold and allergy, sedatives, sleeping pills, tranquilizers, and theophylline (Theo-24, Theolair). 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 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 Zyrtec (cetirizine), call your doctor.
• you should know that Zyrtec (cetirizine) may make you drowsy. Do not drive a car or operate machinery until you know how this medication affects you.
• remember that alcohol can add to the drowsiness caused by this medication. Avoid drinking alcoholic beverages while taking this medication.

Cautions with other medicines

Some medicines and Zyrtec (cetirizine) 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
• ritonavir, a medicine used to treat HIV infection
• any medicine that makes you drowsy, gives you a dry mouth, or makes it difficult for you to pee. Taking Zyrtec (cetirizine) might make these side effects worse.

Mixing Zyrtec (cetirizine) with herbal remedies and supplements

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

Ask your pharmacist for advice.

How and when to take Zyrtec

If you or your child have been prescribed Zyrtec (cetirizine), follow your doctor’s instructions about how and when to take it. If you’ve bought Zyrtec (cetirizine) from a pharmacy or shop, follow the instructions that come with the packet.

How much should I take?

Zyrtec (cetirizine) comes as tablets and capsules (10mg) and as a liquid medicine (labeled either 5mg/ml or 1mg/1ml).

The usual dose in adults is 10mg once daily. A 5 mg product may be appropriate for less severe symptoms.

Doses are usually lower for people with liver or kidney problems.

For children, your doctor will use your child’s weight or age to work out the right dose. If you’ve bought Zyrtec (cetirizine) for a child, follow the instructions on the packet.

Depending on their age, children may take Zyrtec (cetirizine) twice a day. In this case, try to space the doses 10 to 12 hours apart.

Zyrtec dosing information

Zyrtec Adult Dosage

Usual Adult Dose for Allergic Rhinitis

• 5 to 10 mg orally or chewed once a day

Usual Adult Dose for Urticaria

• 5 to 10 mg orally or chewed once a day

Adults 65 years and over

• 5 mg once a day; do not take more than 5 mg in 24 hours.

Dose Adjustment for Renal and Hepatic Impairment

In patients 12 years of age and older with decreased renal function (creatinine clearance 11–31 mL/min), patients on hemodialysis (creatinine clearance less than 7 mL/min), and in hepatically impaired patients, a dose of 5 mg once daily is recommended. Similarly, pediatric patients aged 6 to 11 years with impaired renal or hepatic function should use the lower recommended dose. Because of the difficulty in reliably administering doses of less than 2.5 mg (½ teaspoon) of ZYRTEC syrup and in the absence of pharmacokinetic and safety information for cetirizine in children below the age of 6 years with impaired renal or hepatic function, its use in this impaired patient population is not recommended.

How to take Zyrtec (cetirizine)

You can take Zyrtec (cetirizine) with or without food.

Always take Zyrtec (cetirizine) tablets or capsules with a drink of water, milk or juice. Swallow them whole. Do not chew them.

Zyrtec (cetirizine) liquid may be easier for children to take than tablets or capsules. The liquid 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.

When to take Zyrtec (cetirizine)

You may only need to take Zyrtec (cetirizine) 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 to stop hay fever during spring and summer.

What if I forget to take Zyrtec?

Take your forgotten dose as soon as you remember, unless it is nearly time for your next dose. Do not take a double dose to make up for a forgotten dose.

If you forget to give a dose to a child who is taking Zyrtec (cetirizine) twice a day, you can give the dose if it’s within 4 hours of when they should have had it. If you remember more than 4 hours after, do not give the missed dose. Instead, wait until the next dose and carry on as normal.

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 Zyrtec?

Zyrtec (cetirizine) 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 of the common side effects. If this happens or you’re concerned, contact your doctor.

Can I take Zyrtec (cetirizine) at higher doses than on the packet?

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

Taking high doses of Zyrtec (cetirizine) isn’t suitable for everyone though. Speak to your doctor if you think Zyrtec (cetirizine) isn’t working for you.

Zyrtec Children Dosage

Zyrtec (cetirizine) is usually given once or twice each day.

• Once a day: it can be given in the morning or the evening.
• Twice a day: give once in the morning and once in the evening. Ideally, these times are 10–12 hours apart, for example some time between 7 and 8 am, and between 7 and 8 pm.

Give the medicine at about the same time(s) each day so that this becomes part of your child’s daily routine, which will help you to remember.

Usual Pediatric Dose for Allergic Rhinitis:

• 6 months to 2 years: 2.5 mg orally once a day, 12 months and older may be increased to 2.5 mg orally twice a day.
• 2 to 5 years: 2.5 mg orally once a day, may be increased to 5 mg/day in 1 to 2 divided doses.
• 6 years or older: 5 to 10 mg orally or chewed once a day.

Usual Pediatric Dose for Urticaria:

• 6 months to 2 years: 2.5 mg orally once a day, 12 months and older may be increased to 2.5 mg orally twice a day.
• 2 to 5 years: 2.5 mg orally once a day, may be increased to 5 mg/day in 1 to 2 divided doses.
• 6 years or older: 5 to 10 mg orally or chewed once a day.

What if my child is sick (vomits)?

• If your child is sick less than 30 minutes after having a dose of Zyrtec (cetirizine), give them the same dose again.
• If your child is sick more than 30 minutes after having a dose of Zyrtec (cetirizine), you do not need to give them another dose. Wait until the next normal dose.

If your child is sick again, seek advice from your doctor, pharmacist or hospital. They will decide what to do based on your child’s condition and the specific medicine involved.

What if I forget to give it?

If you normally give it once a day in the morning

• Give the missed dose when you remember during the day.

If you normally give it once a day in the evening

• If you remember before bedtime, give the missed dose. If you remember after this, you do not need to wake your child up to give them the missed dose. You can give the missed dose in the morning.

If you normally give it twice a day

• If you remember up to 4 hours after you should have given a dose, give your child the missed dose. For example, if you usually give a dose at about 7 am, you can give the missed dose at any time up to 11 am. If you remember after that time, do not give the missed dose. Wait until the next normal dose.

What if I give too much?

Zyrtec (cetirizine) is generally a safe drug, and you are unlikely to do harm if you give your child an extra dose of Zyrtec (cetirizine) by mistake. If you are worried that you may have given your child too much, contact your doctor or local pharmacist. Have the medicine packet with you if you telephone for advice.

Are there any possible side-effects?

You use medicines to make your child better, but sometimes they have other effects that you don’t want (side-effects).

• If your child gets palpitations (they may feel a fluttery feeling in chest or say that their heart is racing), contact your doctor straight away or take your child to hospital.

Other side-effects you need to know about:

• Your child may feel sleepy, drowsy or sluggish after taking cetirizine. This can last for a few hours, so it may be better to give cetirizine in the evening rather than the morning.
• Your child may get a dry mouth. Eating citrus fruits (e.g. oranges) or taking sips of water may help.
• Your child’s eyesight may be blurred (fuzzy).
• Your child may have constipation (difficulty doing a poo, or doing a poo less often than usual). Encourage them to drink plenty of fluid and to eat foods that contain fiber (e.g. wholemeal foods, fruit and vegetables). If this is still a problem after 2 weeks, contact your doctor.
• Your child may find that they urinate (do a wee) less often, or have difficulty doing a wee.
• Your child may feel light headed and faint (dizziness). Encourage them not to stand up too quickly, and to sit or lie down if they feel dizzy.
• They may get headaches when they first start taking cetirizine.

There may, sometimes, be other side-effects that are not listed above. If you notice anything unusual and are concerned, contact your doctor.

Can other medicines be given at the same time as Zyrtec (cetirizine)?

• You can give your child medicines that contain paracetamol or ibuprofen, unless your doctor has told you not to.
• Check with your doctor or pharmacist before giving any other medicines to your child. This includes herbal or complementary medicines.

Is there anything else I need to know about Zyrtec (cetirizine)?

• If your child continues to get symptoms of hay fever, contact your doctor. They may consider other treatments.
• Symptoms of eczema and asthma may get worse during the hay fever season. If this happens, contact your doctor.

Where should I keep this medicine?

• Keep the medicine in a cupbord, away from heat and direct sunlight. It does not need to be kept in the fridge.
• Make sure that children cannot see or reach the medicine.
• Keep the medicine in the container it came in.

Zyrtec side effects

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

The most commonly reported side effects include somnolence, dizziness, and headache.

Common side effects

Common side effects of Zyrtec (cetirizine) 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 sleepy and tired
• drowsiness
• excessive tiredness
• headache
• dry mouth
• feeling sick or dizzy
• stomach pain
• diarrhea
• vomiting
• sore throat
• cold-like symptoms of the nose
• itch or rash
• tingling in the hands and feet
• feeling agitated

Children are more likely to get diarrhea or cold-like symptoms of the nose than adults.

Nervous system

• Very common (10% or more): Somnolence (up to 14.3%), headache (up to 14%)
• Common (1% to 10%): Dizziness
• Frequency not reported: Altered sense of taste, paresthesia, hypertonia, tremor, abnormal coordination/incoordination, ataxia, hyperesthesia, hyperkinesia, hypoesthesia, migraine, paralysis, twitching, parosmia, taste loss/perversion
• Postmarketing reports: Convulsions, dysgeusia, dyskinesia, dystonia, syncope, amnesia, vertigo, memory impairment

Gastrointestinal

• Common (1% to 10%): Dry mouth, nausea, diarrhea, vomiting, abdominal pain
• Uncommon (0.1% to 1%): Dyspepsia
• Frequency not reported: Tongue disorder, constipation, flatulence, increased salivation, aggravated tooth caries, eructation, gastritis, hemorrhoids, melena, rectal hemorrhage, stomatitis/ulcerative stomatitis, tongue discoloration/edema, enlarged abdomen

Respiratory

• Common (1% to 10%): Pharyngitis, rhinitis, coughing, epistaxis
• Frequency not reported: Dyspnea, respiratory disorder, bronchospasm, upper respiratory tract infection, dysphonia, bronchitis, hyperventilation, increased sputum, pneumonia, sinusitis, nasal polyp

Other

• Common (1% to 10%): Fatigue
• Frequency not reported: Earache, tinnitus, fever, pain, rigor, thirst, deafness, ototoxicity, accidental injury, face edema, leg edema, malaise
• Postmarketing reports: Asthenia, stillbirth

Psychiatric

• Common (1% to 10%): Insomnia
• Frequency not reported: Nervousness, impaired concentration, confusion, decreased libido, abnormal thinking, anxiety, depersonalization, emotional lability, euphoria, paroniria, sleep disorder
• Postmarketing reports: Agitation, aggression/aggressive reaction, depression, hallucination, tic, suicidal ideation/suicide

Musculoskeletal

• Very rare (less than 0.01%): Myelitis
• Frequency not reported: Back pain, myalgia, arthralgia, bone disorder/fracture, leg cramps, arthritis, arthrosis, muscle weakness

Dermatologic

• Frequency not reported: Pruritus/intense itching, increased sweating, acne, alopecia, bullous eruption, dermatitis, dry skin, eczema, erythematous rash, furunculosis, hyperkeratosis, hypertrichosis, maculopapular rash, photosensitivity/photosensitivity toxic reaction, purpura, seborrhea, skin disorder/nodule
• Postmarketing reports: Rash, urticaria, angioneurotic edema, fixed drug eruption, acute generalized exanthematous pustulosis

Ocular

• Frequency not reported: Eye abnormality, periorbital edema, abnormal vision, eye pain, conjunctivitis, ptosis, visual field defects, blindness, glaucoma, ocular hemorrhage, xerophthalmia, periorbital edema/eye swelling
• Postmarketing reports: Accommodation disorder/loss of accommodation, blurred vision, oculogyration, orofacial dyskinesia

Genitourinary

• Frequency not reported: Polyuria, urinary retention, urinary tract infection, dysmenorrhea, hematuria, micturition frequency, urinary incontinence, female breast pain, intermenstrual bleeding, leukorrhea, menorrhagia, vaginitis
• Postmarketing reports: Dysuria, enuresis

Cardiovascular

• Frequency not reported: Flushing, palpitations, tachycardia, edema/general edema, chest pain, cardiac failure, hypertension, hot flashes, peripheral edema, pallor
• Postmarketing reports: Severe hypotension

Metabolic

• Frequency not reported: Increased appetite, anorexia, increased weight, dehydration, diabetes mellitus

Hepatic

• Frequency not reported: Reversible transaminase elevations
• Postmarketing reports: Abnormal hepatic function (increased transaminases, alkaline phosphatase, GGT, bilirubin), cholestasis, hepatitis

Hypersensitivity

• Frequency not reported: Allergic reactions/delayed allergic reactions
• Postmarketing reports: Hypersensitivity, anaphylactic shock

Hematologic

• Frequency not reported: Lymphadenopathy
• Postmarketing reports: Thrombocytopenia, hemolytic anemia

Renal

• Frequency not reported: Cystitis
• Postmarketing reports: Glomerulonephritis

Serious side effects

It’s rare to have a serious side effect with Zyrtec (cetirizine).

Tell your doctor straight away if you have:

• bruising or bleeding that’s more than normal
• difficulty breathing or swallowing

Zyrtec (cetirizine) may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

Serious allergic reaction

In rare cases, it’s possible to have a serious allergic reaction to Zyrtec (cetirizine). 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 Zyrtec (cetirizine). 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.
• feeling sick – stick to simple meals and don’t eat rich or spicy food
• headache – take an everyday painkiller like paracetamol or ibuprofen
• dry mouth – chew sugar-free gum or suck sugar-free sweets
• diarrhea – drink plenty of water in small, frequent sips. It may also help to take oral rehydration solutions like pedialyte. You can buy these from a pharmacy or supermarket to prevent dehydration. Don’t take any other medicines to treat diarrhea without speaking to a pharmacist or a doctor.

Human Toxicity Reports

In a controlled study of 1 week’s duration in patients 6-11 months of age, those receiving cetirizine exhibited greater irritability/fussiness than those receiving placebo. In a controlled study in patients 12 months of age and older, insomnia occurred more frequently with cetirizine than with placebo (9 vs 5.3%, respectively). In those who received 5 mg or more daily, fatigue occurred in 3.6 or 1.3% and malaise in 3.5 or 1.8% of those receiving cetirizine or placebo, respectively ³.

Fatigue or dizziness occurred in 5.9 or 2%, respectively, of patients 12 years of age and older receiving cetirizine, whereas these effects occurred in 2.6 or 1.2%, respectively, of patients receiving placebo ⁴. Headache was reported in more than 2% of patients 12 years of age and older receiving the drug; however, headache occurred more frequently in patients receiving placebo. In clinical trials in patients 6-11 years of age, headache occurred in 11, 14, or 12.3% of patients receiving 5-mg doses, 10-mg doses, or placebo, respectively. Abnormal coordination, ataxia, confusion, abnormal thinking, agitation, amnesia, anxiety, depersonalization, depression, emotional lability, euphoria, impaired concentration, insomnia, sleep disorders, nervousness, paroniria, dysphonia, asthenia, malaise, pain, hyperesthesia, hypoesthesia, hyperkinesia, hypertonia, migraine headache, myelitis, paralysis, paresthesia, ptosis, syncope, tremor, twitching, and vertigo have been reported in less than 2% of patients 12 years of age and older and children 6-11 years of age receiving cetirizine hydrochloride; however, a causal relationship to the drug has not been established. Aggressive reaction, seizures, hallucinations, suicidal ideation, and suicide have been reported rarely during postmarketing surveillance ⁴.

The most frequent adverse effect in patients 12 years of age and older reported during cetirizine therapy is somnolence, occurring in 11, 14, or 6% of patients receiving 5-mg doses, 10-mg doses, or placebo, respectively ⁴. Overall, somnolence has been reported in 13.7 or 6.3% of patients receiving cetirizine or placebo, respectively. In addition, in clinical trials in patients 6-11 years of age, somnolence occurred in 1.9, 4.2, or 1.3% of patients receiving 5-mg doses, 10-mg doses, or placebo, respectively. Discontinuance of therapy because of somnolence has been reported in 1 or 0.6% of patients receiving cetirizine or placebo, respectively.1 3 In patients 6-24 months of age, somnolence occurred with essentially the same frequency in those who received cetirizine versus placebo.

Adverse effects reported in 1% or more of patients 12 years of age and older with seasonal allergic rhinitis who received extended-release tablets of cetirizine hydrochloride in fixed combination with pseudoephedrine hydrochloride (Zyrtec-D) included insomnia, dry mouth, fatigue, somnolence, pharyngitis, epistaxis, accidental injury, dizziness, and sinusitis ⁴.

A case of recurrent acute hepatitis related to the use of cetirizine has been described in a 26-year-old man who was hospitalized with a week-long history of weakness, nausea, anorexia, and hyperchromic urine, which had developed after 6 days of therapy with oral cetirizine 10 mg/day for allergic rhinitis ⁵. Admission laboratory testing revealed evidence of acute hepatitis and seropositivity for liver-kidney microsome antibodies. Liver biopsy findings of diffuse portal tract and lobular inflammation with a prominent eosinophilic infiltrate were consistent with drug-related hepatitis. The patient was discharged after one week of treatment with tocopherol and glutathione. Three months after discharge, transaminase levels were normal. At 6 months, seropositivity for liver-kidney microsome antibodies was still present, but considerably less intense. The patient had suffered 2 previous episodes of “acute hepatitis of unknown origin,” and both had occurred after cetirizine use ⁵. The study authors indicated cetirizine as the probable cause of acute hepatitis, and the positivity for liver-kidney microsome antibodies is suggestive of an autoimmune mechanism for liver damage. This is the fourth reported case of acute hepatitis associated with cetirizine and the second in which liver-kidney microsome antibodies have been documented. Although cetirizine is considered to have low potential for severe hepatic toxicity, the possibility that it can provoke autoimmune-mediated hepatotoxicity should be considered ⁵.

In U.S. clinical trials, transient reversible hepatic transaminase elevations were observed in <2% of patients during cetirizine therapy ⁶. A case of cetirizine-induced cholestasis in a 28-year-old man with no previous hepatobiliary disease after a 2-year period of taking cetirizine on a daily basis is reported. The treatment of this patient included the use of ursodeoxycholic acid, as well as hydroxyzine, for symptomatic relief of pruritus. In light of the patient’s clinical and biochemical improvement while using hydroxyzine, it appears that the hepatic metabolism of hydroxyzine to metabolites, including cetirizine, is involved in the pathogenesis of this particular case of drug-induced hepatotoxicity. Cetirizine should be considered as a potential cause of drug-induced cholestasis ⁶.

The case of a 29-yr-old woman with pruritus sine materiae who was receiving treatment with oral tablets of 20 mg of cetirizine hydrochloride daily, after which she developed generalized chronic urticaria associated with cetirizine administration is presented ⁷. The patient was admitted for diagnostic purposes, and cetirizine was stopped on admission. Surprisingly, the patient’s urticarial lesions resolved completely within 4 days. Subsequently, the patient showed a pseudoallergic response to a cellular antigen stimulation test performed with cetirizine. The patient was rechallenged with cetirizine 7 wk after discharge. The patient developed a generalized wheal reaction 15 min after an oral dose of 5 mg of cetirizine ⁷.

Dystonia is a movement disorder that causes involuntary contractions of the muscles. Dystonia can affect just one muscle, a group of muscles, or all of the muscles. The most common cause of acquired dystonia in childhood is drugs. Cetirizine is widely used for allergic disorders in childhood. It is without central nervous system side effects at recommended dosages. A case of cetirizine-induced acute acquired dystonia whose symptoms completely resolved after the discontinuation of the drug is reported ⁸.

Cetirizine can cause oculogyric crisis, especially in the pediatric age group according to a retrospective, observational case series and case reports that were collected from the National Registry of Drug-Induced Ocular Side Effects (Casey Eye Institute, Portland, Oregon) ⁹.

Zyrtec 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.

Symptoms of Zyrtec overdose may include:

• restlessness
• irritability
• drowsiness

A case of a 18-year-old female with the history of anorexia for 2 years, who was admitted to a Clinic of Toxicology because of suicidal attempt with use of cetirizine is presented ¹⁰. The laboratory results revealed metabolic acidosis with the pH 7.13; pO2 88 mm Hg; pCO2 36 mm Hg; HCO3 12.0 mmol/L; BE (-)17 mmol/L; SO2 100% and hypokalemia (K+ 3.1 mmol/L). On physical examination blood pressure was 70/40 mm Hg, heart rate was 36-40 beats/min. Convulsions were observed. After about two hours of intensive treatment there was a cardiac arrest in the form of ventricular fibrillation. The resuscitation procedures which lasted for over 2.5 hours were ineffective ¹⁰.. The high dose (270 mg) of cetirizine as well as anorexia and hypokalemia could have been the cause of the unique character of the symptoms in this case. Further investigations should be carried out to confirm the safety of cetirizine in the conditions of massive intoxication and with coexistence of other risk factors ¹⁰.

In one adult patient who took 150 mg of Zyrtec, the patient was somnolent but did not display any other clinical signs or abnormal blood chemistry or hematology results. In an 18 month old pediatric patient who took an overdose of Zyrtec (approximately 180 mg), restlessness and irritability were observed initially; this was followed by drowsiness ¹¹.

Few reports exist on the result of cetirizine overdose in children ¹². A case report of a 12 fold overdose of cetirizine in a four-year-old-boy (weight 20 kg) who accidentally ingested 60 mg. Vomiting was induced 1 1/2 hour after ingestion in the out-patient clinic at the local hospital because of severe drowsiness. Due to continued lethargy he was transferred to the referral pediatric department for further observation. He was fully recovered after five to six hours without any treatment ¹². Electrocardiographic monitoring was normal. Five incidents of cetirizine overdose in children have been reported previously. Drowsiness and sedation were observed, but no other side effects ¹². The risk of cardiac events related to an overdose of cetirizine is extremely small. A certain degree of sedation is to be expected.

A cardiac condition called Torsades de pointes has been associated hypokalemia. A case of a dialysed patient with chronic renal failure who had symptomatic episodes of torsades de pointes in the context of hypokalemia and cetirizine overdose has been described ¹³.

1. 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/
2. Weber-Schoendorfer C, Schaefer C; Reprod Toxicol 26 (1): 19-23 (2008). https://www.sciencedirect.com/science/article/pii/S0890623808001238
3. American Society of Health System Pharmacists; AHFS Drug Information 2009. Bethesda, MD. (2009), p. 27-8
4. American Society of Health System Pharmacists; AHFS Drug Information 2009. Bethesda, MD. (2009), p. 27
5. Pompili M et al; Ann Pharmacother 38 (11): 1844-7 (2004). Available from, as of July 24, 2009 https://www.ncbi.nlm.nih.gov/pubmed/15383643
6. Fong DG et al; J Clin Gastroenterol 31 (3): 250-3 (2000). Available from, as of July 6, 2009 https://www.ncbi.nlm.nih.gov/pubmed/11034010
7. Karamfilov T et al; Br J Dermatol 140 (5): 979-80; 1999 https://onlinelibrary.wiley.com/doi/full/10.1046/j.1365-2133.1999.02849.x
8. Esen I et al; Pediatr Emerg Care 24 (9): 627-8 (2008). Available from, as of July 10, 2009 https://www.ncbi.nlm.nih.gov/pubmed/18797375
9. Fraunfelder FW, Fraunfelder FT; Am J Ophthalmol 137 (2): 355-7;2004 https://www.ncbi.nlm.nih.gov/pubmed/14962433
10. Chodorowski Z et al; Przegl Lek 61 (4): 433-4 (2004). Available from, as of July 6, 2009 https://www.ncbi.nlm.nih.gov/pubmed/15521622
11. US Natl Inst Health; DailyMed. Current Medication Information for Zyrtec – cetirizine hydrochloride https://dailymed.nlm.nih.gov/dailymed/index.cfm
12. Hansen JJ et al; Ugeskr Laeger 160 (41): 5946-7 (1998). Available from, as of July 24, 2009 https://www.ncbi.nlm.nih.gov/pubmed/9786037
13. Renard S et al; Arch Mal Coeur Vaiss 98 (2): 157-61 (2005). Available from, as of July 24, 2009 https://www.ncbi.nlm.nih.gov/pubmed/15787309

What is tylenol

Tylenol is a pain reliever and a fever reducer medicine that contains an active ingredient called acetaminophen (paracetamol). Tylenol (acetaminophen) is a commonly used medicine to relieve mild or moderate pain, such as muscle aches, arthritis, backaches, menstrual periods, toothaches, colds, sore throats or sprains, reactions to vaccinations (shots) and reduce a high temperature (fever) caused by illnesses such as colds and flu.

Tylenol (acetaminophen) is often recommended as one of the first treatments for pain, as it’s safe for most people to take and side effects are rare. Acetaminophen is a common active ingredient to treat pain and reduce fever; it is included in many prescription and over-the-counter (OTC) products.

Tylenol (acetaminophen) has weak anti-inflammatory properties and is used as a common analgesic, but may cause liver, blood cell, and kidney damage.

Tylenol (acetaminophen) is a widely used nonprescription analgesic and antipyretic medication for mild-to-moderate pain and fever. Harmless at low doses, acetaminophen has direct hepatotoxic potential when taken as an overdose and can cause acute liver injury and death from acute liver failure. Even in therapeutic doses, acetaminophen can cause transient serum aminotransferase elevations (liver enzymes).

Tylenol (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). Tylenol (acetaminophen) works by changing the way the body senses pain and by cooling the body.

You can take tylenol for:

• mild to moderate pain, for example backache, headache, migraine, muscle strains, period pain, toothache and aches and pains due to colds and flu
• fever (high temperature)
• osteoarthritis and other painful, non-inflammatory conditions.

Is it okay to drink alcohol when I’m taking Tylenol (acetaminophen)?

Drinking a small amount of alcohol is unlikely to be harmful if you are taking tylenol (acetaminophen).

Tylenol pregnancy

Tylenol is considered the first choice of painkiller if you are pregnant since it has been taken by large numbers of pregnant women without any adverse effect on the mother or baby.

However, if you take tylenol when pregnant, make sure you take it for the shortest possible time.

Can I take tylenol if I’m breastfeeding?

Tylenol is the first choice of painkiller if you are breastfeeding.

It appears in breast milk in very small amounts which are unlikely to harm your baby.

If you take tylenol when breastfeeding, make sure you take it for the shortest possible time.

How does tylenol work?

Tylenol (acetaminophen) is a p-aminophenol derivative, an odorless compound with a slightly bitter taste with analgesic and antipyretic activities that seems to work by blocking chemical messengers in the brain that tell you that you have pain. Although the exact mechanism through which acetaminophen exert its effects has yet to be fully determined, acetaminophen may inhibit the nitric oxide (NO) pathway mediated by a variety of neurotransmitter receptors including N-methyl-D-aspartate (NMDA) and substance P, resulting in elevation of the pain threshold. The antipyretic activity may result from inhibition of prostaglandin synthesis and release in the central nervous system (CNS) and prostaglandin-mediated effects on the heat-regulating body temperature center in the anterior hypothalamus.

Tylenol (acetaminophen) is a widely used analgesic drug. It interacts with various enzyme families including cytochrome P450 (CYP), cyclooxygenase (COX), and nitric oxide synthase (NOS), and this interplay may produce reactive oxygen species (ROS) ¹. The effects of paracetamol (acetaminophen) on prostacyclin, thromboxane, nitric oxide (NO), and oxidative stress in four male subjects who received a single 3 g oral dose of paracetamol was investigated. Thromboxane and prostacyclin synthesis was assessed by measuring their major urinary metabolites 2,3-dinor-thromboxane B2 and 2,3-dinor-6-ketoprostaglandin F1 a, respectively. Endothelial NO synthesis was assessed by measuring nitrite in plasma. Urinary 15(S)-8-iso-prostaglanding F2 a was measured to assess oxidative stress. Plasma oleic acid oxide (cis-EpOA) was measured as a marker of cytochrome P450 activity. Upon paracetamol administration, prostacyclin synthesis was strongly inhibited, while NO synthesis increased and thromboxane synthesis remained almost unchanged. Paracetamol may shift the COX-dependent vasodilatation/vasoconstriction balance at the cost of vasodilatation. This effect may be antagonized by increasing endothelial NO synthesis. High-dosed paracetamol did not increase oxidative stress. At pharmacologically relevant concentrations, paracetamol did not affect NO synthesis/bioavailability by recombinant human endothelial NOS or inducible NOS in rat hepatocytes. It was concluded that paracetamol (acetaminophen) does not increase oxidative stress in humans ¹.

Is tylenol ibuprofen?

No. Ibuprofen belongs to one of a group of painkillers called non-steroidal anti-inflammatory drugs (NSAIDs). Ibuprofen 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.

Paracetamol and ibuprofen are similar strengths, but they work in different ways. So Tylenol (acetaminophen) is better for some types of pain than ibuprofen.

Do not give ibuprofen and paracetamol together, though. Instead, if you’ve given Tylenol (acetaminophen) to your child and they’re still feverish or in pain when the next dose is due, you could try ibuprofen instead.

Don’t take more than the maximum daily dose of either medicine. See your doctor if you’ve tried both ibuprofen and paracetamol and they haven’t helped.

Who can take tylenol

Most people can take tylenol safely, including:

• pregnant women
• breastfeeding women
• children over 2 months of age – lower doses are recommended for young children

If you’re not sure whether you can take tylenol, check the leaflet that comes with it or ask your pharmacist or doctor for advice.

Always get advice before taking tylenol if you:

• have liver or kidney problems
• have problems with alcohol, such as long-term alcohol misuse
• are very underweight
• are taking other medications

Don’t take tylenol if you’ve had an allergic reaction to acetaminophen (paracetamol) in the past.

Before taking tylenol (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.

Tylenol dosage

Tylenol for children

Tylenol is a common painkiller for children. It’s used to treat most kinds of childhood ailments, including headache, tummy ache, earache, and cold symptoms. Tylenol can also be used to reduce fever 100.4 °F (38 °C) or above.

For older children, tylenol is available as tablets.

For young children, tylenol comes as a syrup.

Tylenol is also available as suppositories (a plug of medicine that’s inserted into the back passage). Suppositories are useful to relieve pain and fever in children who find it difficult to swallow tablets or syrup, or who are vomiting a lot.

For children aged 16 and over, read the information on tylenol for adults.

Key facts

• Your child should start to feel better about 30 minutes after taking tylenol tablets or syrup. It may take up to an hour for a suppository to work properly.
• Tylenol comes in a range of different strengths, so always use the measuring device that comes with the medicine. The right dose for your child depends on their age. Always leave 4 to 6 hours between doses. Don’t give more than 4 doses in 24 hours.
• Don’t give your child tylenol with other medicines containing tylenol, such as Children’s Tylenol Cold + Cough + Runny Nose Oral Suspension (only suitable for children 6 to 11 years).
• Tylenol is an everyday medicine, but it can be dangerous if too much is taken. Be careful to keep it out of the reach of children.

Who can and can’t take Tylenol

Children can take tylenol as:

• a liquid syrup – from the age of 3 months (2 months if they have a fever after a vaccination)
• suppository – from the age of 3 months (2 months if they have a fever after a vaccination)
• tablets – from the age of 6 years (500mg so they may need to be broken)
• soluble tablets – from the age of 12 years

Check with your doctor or pharmacist if your child:

• is small for their age as a lower dose may be better
• has had liver or kidney problems
• takes medicine for epilepsy
• takes medicine for tuberculosis (TB)

Giving tylenol with other painkillers

The only safe painkiller to give children alongside tylenol is ibuprofen.

• Do not give tylenol and ibuprofen together, though. Instead, if you’ve given them tylenol and they’re still feverish or in pain when the next dose is due, you could try ibuprofen instead.
• Don’t take more than the maximum daily dose of either medicine. See your doctor if you’ve tried both tylenol and ibuprofen and they haven’t helped. Do not give ibuprofen to your child if they have asthma, unless your doctor has said it’s okay.
• Don’t give your child another medicine with tylenol in it. If they take 2 different medicines that contain tylenol, there’s a risk of overdose. Tylenol is an ingredient in lots of medicines that you can buy from the supermarket or pharmacy.
• Never give aspirin to a child under the age of 16 (unless prescribed by a doctor).

Never give aspirin to a child under the age of 16 (unless prescribed by a doctor).

Tylenol for Children Uses

Temporarily:

• reduces fever
• relieves minor aches and pains due to:
• the common cold
• flu
• headache
• sore throat
• toothache

Tylenol for Children Warnings

Liver warning

This product contains acetaminophen. Severe liver damage may occur if your child takes:

• more than 5 doses in 24 hours, which is the maximum daily amount
• with other drugs containing acetaminophen

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.

Sore throat warning

• If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

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 your child is allergic to acetaminophen or any of the inactive ingredients in this product

Ask a doctor before use if your child has liver disease

Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin. Long-term use of acetaminophen may increase the effect of warfarin, which can increase the risk of bleeding. However, this is unlikely to happen with the occasional use of acetaminophen.

When using this product, do not exceed recommended dose.

Stop use and ask a doctor if:

• pain gets worse or lasts more than 5 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.

Keep out of reach of children.

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away.

Infant tylenol dosage

Infants’ TYLENOL Oral Suspension

Active ingredient: Acetaminophen 160 mg in each 5 mL

Inactive ingredients:

• Cherry: anhydrous citric acid, butylparaben, FD&C red no. 40, flavors, glycerin, high fructose corn syrup, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum or anhydrous citric acid, FD&C red no. 40, flavors, glycerin, high fructose corn syrup, microcrystalline cellulose and carboxymethylcellulose sodium, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum
• Grape: anhydrous citric acid, butylparaben, D&C red no. 33, FD&C blue no. 1, flavors, glycerin, high fructose corn syrup, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum or anhydrous citric acid, D&C red no. 33, FD&C blue no. 1, flavors, glycerin, high fructose corn syrup, microcrystalline cellulose and carboxymethylcellulose sodium, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum
• Dye-Free Cherry: anhydrous citric acid, flavors, glycerin, microcrystalline cellulose and carboxymethylcellulose sodium, potassium sorbate, purified water, sorbitol solution, sucralose, sucrose, xanthan gum

Infant tylenol directions of use

• do not take more than directed (see overdose warning)
• shake well before using
• mL = milliliter
• find the right dose on chart below. If possible, use weight to dose; otherwise, use age
• push air out of syringe. Insert syringe tip into the bottle opening
• flip bottle upside down. Pull yellow part of syringe to the correct dose
• dispense liquid slowly into child’s mouth, toward inner cheek
• repeat dose every 4 hours while symptoms last
• do not give more than 5 times in 24 hours
• replace cap tightly to maintain child resistance

Table 1. Infant tylenol dosage chart

*or as directed by a doctor

Attention: use only enclosed syringe specifically designed for use with this product. Do not use any other dosing device.

Other information: store between 20-25°C (68-77°F)

Do I need to keep paracetamol syrup in the fridge?

No, you don’t need to put paracetamol syrup in the fridge. Keep it in a cupboard away from heat and sunlight.

Children’s tylenol dosage

Children’s TYLENOL Oral Suspension

Active ingredient: Acetaminophen 160 mg in each 5 mL

Inactive ingredients:

• Cherry: anhydrous citric acid, FD&C red no. 40, flavors, glycerin, high fructose corn syrup, microcrystalline cellulose and carboxymethylcellulose sodium, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum or anhydrous citric acid, butylparaben, FD&C red no. 40, flavors, glycerin, high fructose corn syrup, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum
• Grape: anhydrous citric acid, D&C red no. 33, FD&C blue no. 1, flavors, glycerin, high fructose corn syrup, microcrystalline cellulose and carboxymethylcellulose sodium, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum or anhydrous citric acid, butylparaben, D&C red no. 33, FD&C blue no. 1, flavors, glycerin, high fructose corn syrup, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum
• Bubblegum: anhydrous citric acid, D&C red no. 33, FD&C red no. 40, flavors, glycerin, high fructose corn syrup, microcrystalline cellulose and carboxymethylcellulose sodium, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum
• Strawberry: anhydrous citric acid, FD&C red no. 40, flavors, glycerin, high fructose corn syrup, microcrystalline cellulose and carboxymethylcellulose sodium, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum
• Dye-Free Cherry: anhydrous citric acid, flavors, glycerin, microcrystalline cellulose and carboxymethylcellulose sodium, potassium sorbate, purified water, sorbitol solution, sucralose, sucrose, xanthan gum

Children’s tylenol directions of use

• this product does not contain directions or complete warnings for adult use
• do not take more than directed (see overdose warning)
• shake well before using
• mL = milliliter
• find the right dose on the chart below. If possible, use weight to dose; otherwise, use age
• remove the child protective cap and squeeze your child’s dose into the dosing cup
• repeat dose every 4 hours while symptoms last
• do not give more than 5 times in 24 hours

Table 2. Children’s tylenol dosage chart

*or as directed by a doctor

Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

Other information:

• each 5 mL contains: sodium 2 mg (Cherry, Grape, Bubblegum & Strawberry)
• each 5 mL contains: potassium 5 mg (Dye-Free Cherry only)
• store between 20-25° (68-77°F)

Do I need to keep paracetamol syrup in the fridge?

No, you don’t need to put paracetamol syrup in the fridge. Keep it in a cupboard away from heat and sunlight.

Is there any food or drink they need to avoid?

Your child can eat and drink normally while taking paracetamol.

You can give your child paracetamol on an empty stomach.

What if my child vomits?

• If your child vomits less than 30 minutes after having a dose of tylenol tablets or syrup, give them the same dose again.
• If your child vomits more than 30 minutes after a dose of tablets or syrup, you do NOT need to give them another dose. Wait until the next normal dose.

If your child is finding it hard to keep tablets or syrup down, ask your doctor if acetaminophen (paracetamol) suppositories are an option. If they vomit straight after a suppository, you don’t need to give them another dose as the suppository will still work.

What if they take too much?

Giving your child too much tylenol by accident can be dangerous. The effects of an overdose may not be obvious, but they can be serious and need treatment.

If you think you may have given your child an extra dose of tylenol by mistake, wait at least 24 hours before giving them any more.

If you think you may have given your child more than the recommended total daily dose of paracetamol, seek advice immediately, even if your child feels well. Go to your nearest hospital emergency department and seek urgent medical attention.

If you need to take your child to hospital, take the tylenol packet or leaflet inside it plus any remaining medicine with them.

Tylenol for adults

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

It’s 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

• Tylenol takes up to an hour to work.
• The usual dose of tylenol is one or two 500mg tablets at a time.
• Don’t take tylenol with other medicines containing tylenol.
• Tylenol is safe to take in pregnancy and while breastfeeding, at recommended doses.
• Tylenol is widely available as tablets and capsules. For people who find it difficult to swallow tablets or capsules, tylenol is also available as soluble tablets that dissolve in water to make a drink and as a syrup.

Who can and can’t take tylenol

Most people can take tylenol safely, including pregnant and breastfeeding women.

However, some people need to take extra care with tylenol.

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 tylenol on a regular basis.

Tylenol for Adults Uses

• 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

Tylenol for Adults Warnings

Liver warning

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

• more than 4,000 mg of acetaminophen in 24 hours
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while using this product

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 allergic to acetaminophen or any of the inactive ingredients in this product

Ask a doctor before use if you have liver disease

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin. Long-term use of acetaminophen may increase the effect of warfarin, which can increase the risk of bleeding. However, this is unlikely to happen with the occasional use of acetaminophen.

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.

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

Keep out of reach of children.

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away.

How many tylenol can I take?

The usual dose for adults is one or two 500mg tablets up to 4 times in 24 hours.

Always leave at least 4 hours between doses.

Overdosing on tylenol can cause serious side effects. Don’t be tempted to increase the dose or take a double dose if your pain is very bad.

• The total maximum dose of paracetamol for an adult is eight 500mg tablets in 24 hours. Wait at least 4 hours between doses.

Adult dose (over-16s only)

• Total maximum dose of paracetamol for an adult is eight 500mg tablets in 24 hours
  • take one to two 500mg caplets while symptoms last, wait 4-6 hours
  • take one to two 500mg caplets while symptoms last, wait 4-6 hours
  • take one to two 500mg caplets while symptoms last, wait 4-6 hours
  • take one to two 500mg caplets while symptoms last, wait 4-6 hours
• do NOT take more than 6 caplets in 24 hours, unless directed by a doctor
• do NOT take for more than 10 days unless directed by a doctor

Tylenol max dose (over-16s only)

• 8 x 500 mg = 4,000 mg in 24 hours

What if I take too much?

Taking one or 2 extra tablets by accident is unlikely to be harmful. Wait at least 24 hours before you take any more tylenol.

Taking more than 2 extra tylenol tablets can be dangerous and may need treatment.

If you have taken more than the recommended total daily dose of paracetamol, seek advice immediately, even if you feel well. Go to your nearest hospital emergency department and seek urgent medical attention.

If you need to go to hospital, take the tylenol packet or leaflet inside it plus any remaining medicine with you.

What if I forget to take it?

If you take tylenol regularly and miss a dose, take it as soon as you remember. If it’s close to the time for your next dose when you remember, then skip the missed dose.

Never take double doses of tylenol. Never take extra doses to catch up.

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.

Taking tylenol with other painkillers

It’s safe to take tylenol with other types of painkiller that don’t contain tylenol, such as ibuprofen, aspirin and codeine.

Don’t take tylenol alongside other medicines that contain tylenol. If you take 2 different medicines that contain tylenol, there’s a risk of overdose.

Pharmacy remedies that contain tylenol include some:

• migraine remedies
• cough and cold products

Tylenol may also be combined with other painkillers in medicines that have been prescribed by your doctor, such as:

• co-codamol (tylenol and codeine)
• co-dydramol (tylenol and dihydrocodeine)
• tramacet (tylenol and tramadol)

How should tylenol be used?

Acetaminophen comes as a tablet, chewable tablet, capsule, suspension or solution (liquid), extended-release (long-acting) tablet, and orally disintegrating tablet (tablet that dissolves quickly in the mouth), to take by mouth, with or without food. Acetaminophen also comes as a suppository to use rectally. Acetaminophen is available without a prescription, but your doctor may prescribe acetaminophen to treat certain conditions. Follow the directions on the package or prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand.

If you are giving acetaminophen to your child, read the package label carefully to make sure that it is the right product for the age of the child. Do not give children acetaminophen products that are made for adults. Some products for adults and older children may contain too much acetaminophen for a younger child. Check the package label to find out how much medication the child needs. If you know how much your child weighs, give the dose that matches that weight on the chart. If you don’t know your child’s weight, give the dose that matches your child’s age. Ask your child’s doctor if you don’t know how much medication to give your child.

Acetaminophen comes in combination with other medications to treat cough and cold symptoms. Ask your doctor or pharmacist for advice on which product is best for your symptoms. Check nonprescription cough and cold 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.

Swallow the extended-release tablets whole; do not split, chew, crush, or dissolve them.

Place the orally disintegrating tablet (‘Meltaways’) in your mouth and allow to dissolve or chew it before swallowing.

Shake the suspension well before each use to mix the medication evenly. Always use the measuring cup or syringe provided by the manufacturer to measure each dose of the solution or suspension. Do not switch dosing devices between different products; always use the device that comes in the product packaging.

Taking tylenol with other medicines, food and alcohol

Tylenol can react unpredictably with certain other medications. This can affect how well either medicine works and might increase the risk of side effects.

It may not be safe to take tylenol at the same time as:

• other products containing tylenol – including combination products where tylenol is one of the ingredients
• carbamazepine – used to treat epilepsy and some types of pain
• colestyramine – used to reduce itchiness caused by primary biliary cirrhosis (a type of liver disease)
• imatinib and busulfan – used to treat certain types of cancer
• ketoconazole – a type of antifungal medicine
• lixisenatide – used to treat type 2 diabetes
• metoclopramide – used to relieve nausea and vomiting
• phenobarbital, phenytoin and primidone – used to control seizures
• warfarin – used to prevent blood clots

Check the leaflet that comes with your medicine to see if it can be taken with tylenol. Ask a pharmacist or doctor if you’re not sure.

There are no known problems caused by taking tylenol with any specific foods or by drinking moderate amounts of alcohol while taking tylenol.

Tylenol side effects

Tylenol (acetaminophen) may cause side effects, but side effects from tylenol are rare, but can include:

• an allergic reaction, which can cause a rash and swelling
• flushing, low blood pressure and a fast heartbeat – this can sometimes happen when tylenol is given in hospital into a vein in your arm
• blood disorders, such as thrombocytopenia (low number of platelet cells) and leukopenia (low number of white blood cells)
• liver and kidney damage if you take too much (overdose) – this can be fatal in severe cases

Speak to a pharmacist or doctor if you develop any troublesome side effects that you think could be caused by tylenol.

Some side effects of tylenol can be serious. If you experience any of the following symptoms, stop taking tylenol and call your doctor immediately or get emergency medical attention:

• getting a skin rash that may include itchy, red, swollen, blistered or peeling skin
• rash
• hives
• itching
• swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
• hoarseness
• difficulty breathing or swallowing

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

Human Exposure and Toxicity

Nausea, vomiting, and abdominal pain usually occur within 2-3 hours after ingestion of toxic doses of the drug acetaminophen. In severe poisoning, central nervous system (CNS) stimulation, excitement, and delirium may occur initially. This may be followed by CNS depression, stupor, hypothermia, marked prostration, rapid shallow breathing, rapid weak irregular pulse, low blood pressure, and circulatory failure. When an individual has ingested a toxic dose of acetaminophen, the individual should be hospitalized for several days of observation, even if there are no apparent ill effects, because maximum liver damage and/or cardiotoxic effects usually do not become apparent until 2-4 days after ingestion of the drug. Other symptoms of acute poisoning include cerebral edema and nonspecific myocardial depression. Vascular collapse results from the relative hypoxia and from a central depressant action that occurs only with massive doses. Shock may develop if vasodilation is marked. Fatal seizures may occur. Coma usually precedes death, which may occur suddenly or may be delayed for several days. Biopsy of the liver reveals centralobular necrosis with sparing of the periportal area. There have been reports of acute myocardial necrosis and pericarditis in individuals with acetaminophen poisoning. Hypoglycemia, which can progress to coma have been reported in patients ingesting toxic doses of acetaminophen. Low prothrombin levels and thrombocytopenia have been reported in patients with acetaminophen poisoning. Skin reactions of an erythematous or urticarial nature which may be accompanied by fever and oral mucosal lesions also have been reported. For use anytime during pregnancy, 781 exposures were recorded, and possible associations with congenital dislocation of the hip (eight cases) and clubfoot (six cases) were found. There is inadequate evidence in humans for the carcinogenicity of acetaminophen.

Evidence for Carcinogenicity

There is inadequate evidence in humans for the carcinogenicity of paracetamol. There is inadequate evidence in experimental animals for the carcinogenicity of paracetamol ². Overall evaluation: Paracetamol is not classifiable as to its carcinogenicity to humans (Group 3) ².

Animal Toxicity Studies

Concern has been raised over chemical-induced disruption of ovary development during fetal life resulting in long-lasting consequences only manifesting themselves much later during adulthood. A growing body of evidence suggests that prenatal exposure to the mild analgesic acetaminophen/paracetamol can cause such a scenario ³. In a review of three recent reports that collectively indicate that prenatal exposure in a period of 13.5 days post coitum in both rats and mouse can result in reduced female reproductive health. The combined data show that the exposure results in the reduction of primordial follicles, irregular menstrual cycle, premature absence of corpus luteum, as well as reduced fertility, resembling premature ovarian insufficiency syndrome in humans that is linked to premature menopause ³. This could especially affect the Western parts of the world, where the age for childbirth is continuously being increased and acetaminophen is recommended during pregnancy for pain and fever ³. The study authors highlight an urgent need for more studies to verify these data including both experimental and epidemiological approaches ³.

There is inadequate evidence in experimental animals for the carcinogenicity of acetaminophen. In rats fasted 24 hours and given a single dose of acetaminophen (2 g/kg) by gavage, liver necrosis around the central vein was noted at 9-12 hours and was much more extensive at 24 hours after treatment. In mice after dietary exposure to acetaminophen up to 6400 mg/kg daily for 13 weeks hepatotoxicity, organ weight changes and deaths were observed. Cats are particularly susceptible to acetaminophen intoxication, developing more diffuse liver changes, while hepatic centrilobular lesions found in dogs. High doses of acetaminophen caused testicular atrophy and delay in spermiogenesis in mice. Furthermore, reductions in the fertility and neonatal survival in mice were seen in the F0 generation and decreases in F1 pup weights were found at acetaminophen dose 1430 mg/kg. Acetaminophen was not mutagenic in Salmonella typhimurium assay with or without metabolic activation in six strains: TA1535, TA1537, TA1538, TA100, TA97 and TA98. In vitro and animal data indicate that small quantities of acetaminophen are metabolized by a cytochrome P-450 microsomal enzyme to a reactive intermediate metabolite (N-acetyl-p-benzoquinoneimine, N-acetylimidoquinone, NAPQI) which is further metabolized via conjugation with glutathione and ultimately excreted in urine as a mercapturic acid. It has been suggested that this intermediate metabolite is responsible for acetaminophen-induced liver necrosis in cases of overdose. Excipients found in liquid formulations of acetaminophen may decrease its liver toxicity.

Ecotoxicity Studies

Daphnia magna was the most susceptible among the test organisms to the environmental effects of acetaminophen. Acetaminophen has recently been identified as a promising snake toxicant to reduce brown tree snake populations on Guam, while posing only the minimal risks to non-target rodents, cats, pigs and birds.

Tylenol poisoning

Acetaminophen toxicity may result from a single toxic dose, from repeated ingestion of large doses of acetaminophen (e.g., 7.5-10 g daily for 1-2 days), or from chronic ingestion of the drug ⁴. Dose-dependent, hepatic necrosis is the most serious acute toxic effect associated with overdosage and is potentially fatal ⁴.

A case report of oral acetaminophen toxicity in a term newborn infant successfully treated with a 20 hr intravenous N-acetylcysteine infusion protocol without any adverse effects. This case report supports the use of N-acetylcysteine to treat neonatal acetaminophen toxicity ⁵.

A 3.5 yr old girl with an upper respiratory infection died of an acetaminophen overdose ⁶. When the child’s temperature remained elevated after treatment with 120 mg every 4 hr for 3 doses, dosage was increased to 720 mg every 3 hr. Over the next 24 hr the patient received 5.04 g ⁶.

A 63 yr old man with acute psittacosis had severe hepatic damage after ingesting about 10 g acetaminophen over a 48 hr period. Transaminase levels showed striking elevation, with a serum glutamic-oxaloacetic transaminase level of over 15000 iu/L, and decreased rapidly, consistent with toxic insult. The liver showed severe central necrosis at autopsy ⁷.

An 18-year-old woman, gravida 1, presented at 33 weeks’ gestation with signs and symptoms consistent with acute fatty liver of pregnancy and fetal death. Markedly elevated transaminases prompted a search for other etiologies, and acetaminophen toxicity was diagnosed. Liver biopsy revealed acute fatty liver of pregnancy and toxin-induced injury consistent with acetaminophen use. The patient’s condition deteriorated, resulting in fulminant hepatic failure and requiring postpartum orthotopic liver transplantation. The combination of acute fatty liver of pregnancy and acetaminophen toxicity resulted in acute liver failure ⁸.

A case involving a 22-year-old woman in her 31st week of pregnancy who consumed a 15 g dose of acetaminophen, followed by a 50 g dose 1 week later is reported ⁹. Fetal distress was observed 16 hours after the second overdose, as evidenced by complete lack of fetal movements and breathing, a marked decrease in fetal heart rate beat-to-beat variability with no accelerations, and a falling baseline rate. Because of the fetal condition, labor was induced (cesarean section was excluded because of the mothers incipient hepatic failure). Eighty-four hours after the overdose, a 2198 g female infant was delivered with an Apgar scores at 1 and 5 min of 9 and 10, respectively. Except for hypoglycemia, mild respiratory disease, and mild jaundice, the newborn did well. Liver enzymes were always within normal range, and the jaundice was compatible with immaturity. Acetaminophen was not detected in the cord blood. Follow-up examinations of the infant at 6 weeks and again at 6 months were normal. Protection against serious or permanent liver damage was probably afforded by the prompt administration of iv N-acetylcysteine ⁹.

Nausea, vomiting, and abdominal pain usually occur within 2-3 hours after ingestion of toxic doses of the drug. Unlike aspirin, acetaminophen does not usually cause acid/base changes in toxic doses ⁴. In severe poisoning, CNS stimulation, excitement, and delirium may occur initially. This may be followed by CNS (central nervous system) depression; stupor; hypothermia; marked prostration; rapid, shallow breathing; rapid, weak, irregular pulse; low blood pressure; and circulatory failure. Vascular collapse results from the relative hypoxia and from a central depressant action that occurs only with massive doses. Shock may develop if vasodilation is marked. Fatal asphyxial seizures may occur. Coma usually precedes death, which may occur suddenly or may be delayed for several days ⁴.

Acetaminophen toxicity usually involves 4 phases ⁴:

1. Anorexia, nausea, vomiting, malaise, and diaphoresis (which inappropriately may prompt administration of additional acetaminophen);
2. Resolution of phase-1 manifestations and replacement with right upper quadrant pain or tenderness, liver enlargement, elevated bilirubin and hepatic enzyme concentrations, prolongation of prothrombin time, and occasionally oliguria;
3. Anorexia, nausea, vomiting, and malaise recur (usually 3-5 days after initial symptom onset) and signs of hepatic failure (e.g., jaundice, hypoglycemia, coagulopathy, encephalopathy) and possibly renal failure and cardiomyopathy develop; and
4. Recovery or progression to fatal complete liver failure.

Three hundred and seven cases of liver injury associated with acetaminophen use were reported to the US Food and Drug Administration (FDA) from January 1998 to July 2001 ¹⁰. Sixty percent of these adverse events were categorized as severe life-threatening injury with liver failure (category 4); 40% of patients died. Review of these case reports indicates that use of higher than recommended daily dosages of acetaminophen results in adverse hepatotoxic effects more often than use of recommended dosages ¹⁰.

The Rocky Mountain Poison and Drug Center ⁹ reported the results of a nationwide study on acetaminophen overdose during pregnancy involving 113 women. Of the 60 cases that had appropriate laboratory and pregnancy outcome data, 19 occurred in the 1st trimester, 22 during the 2nd trimester, and 19 during the 3rd trimester. In those cases with a potentially toxic serum level of acetaminophen, early treatment with N-acetylcysteine was statistically associated with an improved pregnancy outcome by lessening the incidence of spontaneous abortion and fetal death ⁹. Only one congenital anomaly was observed in the series and that involved a 3rd trimester overdose with nontoxic maternal acetaminophen serum levels ⁹.

Very high levels of acetaminophen can cause lactic acidosis and altered mental status by uncertain mechanisms, probably involving mitochondrial dysfunctin ¹¹. Symptoms of acute acetaminophen poisoning both metabolic acidosis and metabolic alkalosis have been noted; cerebral edema & nonspecific myocardial depression have also occurred ¹². Biopsy of the liver reveals centralobular necrosis with sparing of the periportal area ¹².

Low prothrombin levels have been reported in patients with acetaminophen poisoning and in one patient fatal GI hemorrhage was attributed to hypoprothrombinemia. Thrombocytopenia also has been reported. Toxic doses of p-aminophenol derivatives may produce skin reactions of an erythematous or urticarial nature which may be accompanied by fever and oral mucosal lesions ¹³.

Eighty-eight patients with acetaminophen-induced acute liver failure were recruited ¹⁴. Control groups included patients with nonacetaminophen-induced acute liver failure (n = 13), nonhepatic multiple organ failure (n = 28), chronic liver disease (n = 19), and healthy controls (n = 11). Total and caspase-cleaved cytokeratin-18 (M65 and M30) measured at admission and sequentially on days 3, 7, and 10 following admission. Levels were also determined from hepatic vein, portal vein, and systemic arterial blood in seven patients undergoing transplantation. Protein arrays of liver homogenates from patients with acetaminophen-induced acute liver failure were assessed for apoptosis-associated proteins, and histological assessment of liver tissue was performed. Admission M30 levels were significantly elevated in acetaminophen-induced acute liver failure and non-acetaminophen induced acute liver failure patients compared with multiple organ failure, chronic liver disease, and healthy controls. Admission M30 levels correlated with outcome with area under receiver operating characteristic of 0.755. Peak levels in patients with acute liver failure were seen at admission then fell significantly but did not normalize over 10 days. A negative gradient of M30 from the portal to hepatic vein was demonstrated in patients with acetaminophen-induced acute liver failure at the time of liver transplant. Analysis of protein array data demonstrated lower apoptosis-associated protein and higher catalase concentrations in acetaminophen-induced acute liver failure compared with controls. Explant histological analysis revealed evidence of cellular proliferation with an absence of histological evidence of apoptosis. Hepatocellular apoptosis occurs in the early phases of human acetaminophen-induced acute liver failure, peaking on day 1 of hospital admission, and correlates strongly with poor outcome. Hepatic regenerative/tissue repair responses prevail during the later stages of acute liver failure where elevated levels of M30 are likely to reflect epithelial cell death in extrahepatic organs ¹⁴.

The U.S. Food and Drug Administration (FDA) is informing the public that acetaminophen has been associated with a risk of rare but serious skin reactions. These skin reactions, known as Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP), can be fatal ¹⁵. Reddening of the skin, rash, blisters, and detachment of the upper surface of the skin can occur with the use of drug products that contain acetaminophen. These reactions can occur with first-time use of acetaminophen or at any time while it is being taken. … Anyone who develops a skin rash or reaction while using acetaminophen or any other pain reliever/fever reducer should stop the drug and seek medical attention right away. Anyone who has experienced a serious skin reaction with acetaminophen should not take the drug again and should contact their health care professional to discuss alternative pain relievers/fever reducers. Health care professionals should be aware of this rare risk and consider acetaminophen, along with other drugs already known to have such an association, when assessing patients with potentially drug-induced skin reactions.

Tylenol 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.

Can you overdose on Tylenol?

Yes. Taking too much tylenol, known as an overdose, can be very dangerous.

If you’ve taken more than the recommended maximum dose, go to your nearest accident and emergency (A&E) department as soon as possible.

It can be helpful to take any remaining medicine and the box or leaflet with you to a hospital accident and emergency department if you can.

Some people feel sick, vomit or have abdominal (tummy) pain after taking too much tylenol, but often there are no obvious symptoms at first.

• Go to a hospital accident and emergency department even if you’re feeling well.

When an individual has ingested a toxic dose of acetaminophen, the individual should be hospitalized for several days of observation, even if there are no apparent ill effects, because maximum liver damage usually does not become apparent until 2-4 days after ingestion of the drug ¹³. Transient azotemia and renal tubular necrosis have been reported in patients with acetaminophen poisoning; renal failure is often associated with fatality. There have been reports of acute myocardial necrosis and pericarditis in individuals with acetaminophen poisoning. Maximum cardiotoxic effects of these drugs appear to be delayed in a manner similar to hepatotoxic effects. Hypoglycemia, which can progress to coma, and metabolic acidosis have been reported in patients ingesting toxic doses of acetaminophen and cerebral edema occurred in one patient ¹³.

In acute acetaminophen overdosage, dose-dependent, potentially fatal hepatic necrosis is the most serious adverse effect. Renal tubular necrosis, hypoglycemic coma, and thrombocytopenia may also occur. Plasma acetaminophen levels > 300 ug/mL at 4 hours after oral ingestion were associated with hepatic damage in 90% of patients; minimal hepatic damage is anticipated if plasma levels at 4 hours are < 150 ug/mL or < 37.5 ug/mL at 12 hours after ingestion. Early symptoms following a potentially hepatotoxic overdose may include: nausea, vomiting, diaphoresis, and general malaise. Clinical and laboratory evidence of hepatic toxicity may not be apparent until 48 to 72 hours post-ingestion ¹⁶.

1. Trettin A, Böhmer A, Suchy M-T, et al. Effects of Paracetamol on NOS, COX, and CYP Activity and on Oxidative Stress in Healthy Male Subjects, Rat Hepatocytes, and Recombinant NOS. Oxidative Medicine and Cellular Longevity. 2014;2014:212576. doi:10.1155/2014/212576. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3988730/
2. Monographs on the Evaluation of the Carcinogenic Risk of Chemicals to Humans. Geneva: World Health Organization, International Agency for Research on Cancer, 1972-PRESENT. http://monographs.iarc.fr/ENG/Classification/index.php
3. Is exposure during pregnancy to acetaminophen/paracetamol disrupting female reproductive development? Endocr Connect. 2018, Jan; 7(1):149-158.
4. American Society of Health-System Pharmacists 2013; Drug Information 2013. Bethesda, MD. 2013, p. 2209
5. Walls L et al; J Perinatol 27 (2): 133-5; 2007
6. Nogen A, Bremmer J; J Pediatr 92 (MAY): 832; 1978
7. Davis AM et al; Am J Med 74 (2): 349; 1983
8. Gill EJ t al; J Reprod Med 47 (7): 584-6; 2002
9. Briggs, G.G., Freeman, R.K., Yaffee, S.J.; Drugs in Pregancy and Lactation Nineth Edition. Wolters Kluwer/Lippincott Williams & Wilkins, Philadelphia, PA. 2011, p. 9
10. American Society of Health-System Pharmacists 2013; Drug Information 2013. Bethesda, MD. 2013, p. 2211
11. OLSON, K.R. (Ed). Poisoning and Drug Overdose, Sixth Edition. McGraw-Hill, New York, NY 2012, p. 69
12. Hardman, J.G., L.E. Limbird, P.B., A.G. Gilman. Goodman and Gilman’s The Pharmacological Basis of Therapeutics. 10th ed. New York, NY: McGraw-Hill, 2001., p. 704
13. American Society of Health-System Pharmacists 2013; Drug Information 2013. Bethesda, MD. 2013, p. 2210
14. Possamai LA et al; Crit Care Med 41 (11): 2543-50; 2013
15. US FDA; FDA Drug Safety Communication: FDA Warns of Rare but Serious Skin Reactions with the Pain Reliever/Fever Reducer Acetaminophen. https://www.fda.gov/drugs/drugsafety/ucm363041.htm
16. US Natl Inst Health; DailyMed. Current Medication Information for OFIRMEV (acetaminophen) injection, solution (October 2013). Available from, as of March 6, 2014

What is benadryl

Benadryl is a medicine that relieves allergy that contain an active ingredient called Diphenhydramine, which is an antihistamine [histamine-1 (H1) receptor blocker or antagonist] that reduces the effects of natural chemical histamine in your body. 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.

Benadryl (Diphenhydramine) is used to relieve red, irritated, itchy, watery eyes; sneezing; and runny nose caused by hay fever, allergies, or the common cold. Benadryl (Diphenhydramine) is also used to relieve cough caused by minor throat or airway irritation. Benadryl (Diphenhydramine) is also used to prevent and treat motion sickness, and to treat insomnia (difficulty falling asleep or staying asleep). Benadryl (Diphenhydramine) is also used to control abnormal movements in people who have early stage parkinsonian syndrome (a disorder of the nervous system that causes difficulties with movement, muscle control, and balance) or who are experiencing movement problems as a side effect of a medication.

Benadryl (Diphenhydramine) will relieve the symptoms of these conditions but will not treat the cause of the symptoms or speed recovery. Benadryl (Diphenhydramine) should not be used to cause sleepiness in children. Benadryl (Diphenhydramine) 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.

Like other antihistamines, Benadryl (Diphenhydramine) should be used with caution in infants and young children and should NOT be used in premature or full-term neonates ¹. Children younger than 6 years of age should receive Benadryl (Diphenhydramine) only under the direction of a physician ¹. Safety and efficacy of Benadryl (Diphenhydramine) as a nighttime sleep aid in children younger than 12 years of age have not been established ¹. In addition, children may be more prone than adults to paradoxically experience CNS stimulation rather than sedation when antihistamines are used as nighttime sleep aids ¹. Because Benadryl (Diphenhydramine) may cause marked drowsiness that may be potentiated by other CNS depressants (e.g., sedatives, tranquilizers), the antihistamine should be used in children receiving one of these drugs only under the direction of a physician ¹.

Because Benadryl (Diphenhydramine) has an atropine-like action, it should be used with caution in patients who have asthma ². Patients should be cautioned about taking Benadryl (Diphenhydramine) with other depressant substances, because of the additive effect. Persons should also be advised not to operate a motor vehicle, fly an airplane, or operate hazardous machinery while on this drug. The incidence of side effects is approximately 30-60% ².

The most frequent side effect of Benadryl (Diphenhydramine) the first-generation H1 antagonists is sedation. Although sedation may be a desirable adjunct in the treatment of some patients, it may interfere with the patient’s daytime activities ³. Concurrent ingestion of alcohol or other CNS depressants produces an additive effect that impairs motor skills. Other untoward reactions referable to central actions include dizziness, tinnitus, lassitude, incoordination, fatigue, blurred vision, diplopia, euphoria, nervousness, insomnia, and tremors.

What does Benadryl do

Benadryl (Diphenhydramine) is a first generation antihistamine with sedative and anti-allergic properties. Benadryl (Diphenhydramine) competitively inhibits the histamine-1 (H1) receptor, thereby alleviating the symptoms caused by endogenous histamine on bronchial, capillary and gastrointestinal smooth muscles. This prevents histamine-induced bronchoconstriction, vasodilation, increased capillary permeability, and gastrointestinal smooth muscle spasms.

Benadryl is used to treat sneezing, runny nose, watery eyes, hives, skin rash, itching (pruritus), and other cold or allergy symptoms.

Benadryl is also used to treat motion sickness as an antiemetic, antitussive, to induce sleep, and to treat certain symptoms (e.g. tremors) of Parkinson’s disease (off-label use).

Benadryl ingredients

Benadryl active ingredient: Diphenhydramine HCl 25 mg

Ingredient Purpose: Antihistamine

Inactive Ingredients

• carnauba wax, croscarmellose sodium, D&C red no. 27 aluminum lake, dibasic calcium phosphate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide

Benadryl and alcohol

Ask your doctor before using Benadryl together with ethanol. Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while you are taking Benadryl. Using Benadryl together with alcohol increases your risk for overdose. You should be warned not to exceed recommended dosages and to avoid activities requiring mental alertness. If your doctor prescribes these medications together, you may need a dose adjustment to safely take this combination. It is important to tell your doctor about all other medications you use, including vitamins and herbs. Do not stop using any medications without first talking to your doctor.

Benadryl Pregnancy Warnings

Animal models have failed to reveal evidence of impaired fertility or fetal harm at doses up to 5 times the human dose. There are no controlled data in human pregnancy.

• US FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.

Use is recommended only if clearly needed and the benefit outweighs the risk.

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

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 allergy symptoms and other conditions during pregnancy. Treating allergy symptoms may reduce asthma symptoms and the need for more asthma medicine. Allergy treatment can also result in better sleep and emotional well-being.

Can use of Benadryl during pregnancy cause birth defects?

It is unlikely that Benadryl (Diphenhydramine) would cause an increased chance for birth defects. Most studies show no increased chance of birth defects with the use of Benadryl (Diphenhydramine) in early pregnancy. While one study suggested an increased chance of several types of birth defects, the study does not prove causation and these findings have not been confirmed.

Can use of Benadryl cause other pregnancy complications?

At recommended doses, Benadryl (Diphenhydramine) has not been shown to cause problems in pregnancy. There are rare reports of problems with the use of Benadryl (Diphenhydramine) in the third trimester. These reports usually involve using more of the medication than is recommended or using it for long-term (chronic) use. High levels of Benadryl (Diphenhydramine) could cause uterine hyperstimulation (contractions that are too long or too often). Uterine hyperstimulation can affect the developing baby such as increasing the baby’s heart rate. Uterine contractions can also lead to serious complications, including uterine rupture (a tear in the uterus) or placental abruption (when the placenta pulls away from the wall of the uterus before the baby is born).

Also, there are a few reports of withdrawal symptoms in infants whose mothers took Benadryl (Diphenhydramine) daily throughout pregnancy.

Is there anyone who should avoid taking Benadryl during pregnancy?

A single human report and animal data have suggested that the combination of two medications: temazepam (a benzodiazepine) and Benadryl (Diphenhydramine) may increase the chance for stillbirth or infant death shortly after birth ⁴. It is unknown if this interaction will occur with all medications in the benzodiazepine class. Women taking benzodiazepines should talk with their health care provider before taking Benadryl (Diphenhydramine) during their pregnancy ⁴.

Benadryl and Breastfeeding

Benadryl (Diphenhydramine) has been detected in milk ¹. Because of the potential for serious adverse reactions to antihistamines in nursing infants, a decision should be made whether to discontinue nursing or Benadryl (Diphenhydramine), taking into account the importance of the drug to the woman.

Because Benadryl (Diphenhydramine) can cause sleepiness in adults, it may do the same for the baby ⁵. If you need to take an antihistamine regularly, ask your health care provider if a non-sedating one would work for your symptoms.

Antihistamines, as a group, might lower the amount of milk a woman makes, especially when using long acting antihistamines ⁶ and when used with decongestants like pseudoephedrine or phenylephrine. This is less likely to be of concern in a woman with established milk supply (has been breastfeeding for a while).

Two studies ⁷ with women who used an antihistamine (not just Benadryl) while breastfeeding reported their babies were irritable, sleepier, and/or slept less.

Be sure to discuss any medications you are taking and your options for breastfeeding with your health care provider as well as the baby’s pediatrician.

What is Benadryl used for

Benadryl 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
• Temporarily relieves these symptoms due to the common cold:
  • Runny nose
  • Sneezing

How should Benadryl be used?

Benadryl (Diphenhydramine) comes as a tablet, a rapidly disintegrating (dissolving) tablet, a capsule, a liquid-filled capsule, a dissolving strip, powder, and a liquid to take by mouth. When Benadryl (Diphenhydramine) is used for the relief of allergies, cold, and cough symptoms, it is usually taken every 4 to 6 hours. When Benadryl (Diphenhydramine) is used to treat motion sickness, it is usually taken 30 minutes before departure and, if needed, before meals and at bedtime. When Benadryl (Diphenhydramine) is used to treat insomnia it is taken at bedtime (30 minutes before planned sleep). When Benadryl (Diphenhydramine) is used to treat abnormal movements, it is usually taken three times a day at first and then taken 4 times a day. 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 Benadryl (Diphenhydramine) exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor or directed on the label.

Benadryl (Diphenhydramine) comes alone and in combination with pain relievers, fever reducers, and decongestants. Ask your doctor or pharmacist for advice on which product is best for your symptoms. Check nonprescription cough and cold 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 Benadryl (Diphenhydramine), 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 Benadryl (Diphenhydramine) or a combination product that contains Benadryl (Diphenhydramine) 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 Benadryl (Diphenhydramine) products that are made for adults to children.

Before you give a Benadryl (Diphenhydramine) 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.

If you are taking the liquid, do not use a household spoon to measure your dose. Use the measuring spoon or cup that came with the medication or use a spoon made especially for measuring medication.

If you are taking the dissolving strips, place the strips on your tongue one at a time and swallow after they melt.

If you are taking the rapidly dissolving tablets, place a tablet on your tongue and close your mouth. The tablet will quickly dissolve and can be swallowed with or without water.

If you are taking the capsules, swallow them whole. Do not try to break the capsules.

What should I do if I forget a dose?

Benadryl (Diphenhydramine) is usually taken as needed. If your doctor has told you to take Benadryl (Diphenhydramine) 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.

Before taking Benadryl – Precautions

• tell your doctor and pharmacist if you are allergic to Benadryl (Diphenhydramine) 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: other Benadryl (Diphenhydramine) products (even those that are used on the skin); other medications for colds, hay fever, or allergies; medications for anxiety, depression, or seizures; muscle relaxants; narcotic medications for pain; sedatives; sleeping pills; and tranquilizers.
• tell your doctor if you have or have ever had asthma, emphysema, chronic bronchitis, or other types of lung disease; glaucoma (a condition in which increased pressure in the eye can lead to gradual loss of vision); ulcers; difficulty urinating (due to an enlarged prostate gland); heart disease; high blood pressure; seizures; or an overactive thyroid gland.If you will be using the liquid, tell your doctor if you have been told to follow a low-sodium diet.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking Benadryl (Diphenhydramine), call your doctor.
• talk to your doctor about the risks and benefits of taking Benadryl (Diphenhydramine) if you are 65 years of age or older. Older adults should not usually take Benadryl (Diphenhydramine) because it is not as safe as other medications that can be used to treat the same conditions.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking Benadryl (Diphenhydramine).
• you should know that this medication may make you drowsy. Do not drive a car or operate machinery until you know how this medication affects you.
• remember that alcohol can add to the drowsiness caused by this medication. Avoid alcoholic beverages while you are taking this medication.
• 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 chewable tablets and rapidly disintegrating tablets that contain Benadryl (Diphenhydramine) may be sweetened with aspartame, a source of phenylalanine.
• Like other antihistamines, Benadryl (Diphenhydramine) should be used with caution in infants and young children and should not be used in premature or full-term neonates. Children younger than 6 years of age should receive Benadryl (Diphenhydramine) only under the direction of a physician. Safety and efficacy of Benadryl (Diphenhydramine) as a nighttime sleep aid in children younger than 12 years of age have not been established. In addition, children may be more prone than adults to paradoxically experience CNS stimulation rather than sedation when antihistamines are used as nighttime sleep aids. Because Benadryl (Diphenhydramine) may cause marked drowsiness that may be potentiated by other CNS depressants (e.g., sedatives, tranquilizers), the antihistamine should be used in children receiving one of these drugs only under the direction of a physician.

Benadryl dosage

Benadryl Allergy ULTRATAB Tablets Dosage

Benadryl Allergy ULTRATAB Tablets Ingredient: Diphenhydramine HCl 25 mg

How often can you take Benadryl Allergy ULTRATAB Tablets:

• Take every 4 to 6 hours, or as directed by a doctor
• Do NOT take more than 6 times in 24 hours
  • Adults and children 12 years and over: 1 to 2 tablets
  • Children 6 to under 12 years: 1 tablet
  • Children under 6 years: do NOT use

Other Information:

• Each tablet also contains: calcium 15 mg
• Store between 20-25° C (68-77° F). Protect from light.

Benadryl Allergy ULTRATAB Tablets WARNINGS

Do NOT use

• To make a child sleepy
• With any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if you have:

• A breathing problem such as emphysema or chronic bronchitis
• Glaucoma
• Trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

When using this product:

• Marked drowsiness may occur
• Avoid alcoholic drinks
• Alcohol, sedatives, and tranquilizers may increase drowsiness
• Be careful when driving a motor vehicle or operating machinery
• Excitability may occur, especially in children

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.

Benadryl Allergy Plus Congestion Dosage

Benadryl Allergy Plus Congestion Ingredient: Diphenhydramine HCl 25 mg (Antihistamine) plus Phenylephrine HCl 10 mg (nasal decongestant)

Inactive Ingredients

• carnauba wax, FD&C blue no. 1 aluminum lake, magnesium stearate, microcrystalline cellulose, modified starch, polyethylene glycol, polyvinyl alcohol, powdered cellulose, pregelatinized starch, sodium starch glycolate, talc, titanium dioxide

How often can you take Benadryl Allergy Plus Congestion tablets:

• Adults and children 12 years and over:
  • Take 1 tablet every 4 hours
  • Do not take more than 6 tablets in 24 hours
• Children under 12 years: Ask a doctor

Other Information:

• Store between 20-25° C (68-77° F).

Benadryl Allergy Plus Congestion 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
• Nasal Congestion

Temporarily relieves these symptoms due to the common cold:

• Runny nose
• Sneezing
• Nasal Congestion

Temporarily relieves sinus congestion and pressure

Benadryl Allergy Plus Congestion WARNINGS

Do NOT use

• To make a child sleepy
• With any other product containing diphenhydramine, even one used on skin
• 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.

Ask a doctor before use if you have:

• Heart disease
• High blood pressure
• Thyroid disease
• Diabetes
• Trouble urinating due to an enlarged prostate gland
• A breathing problem such as emphysema or chronic bronchitis
• Glaucoma

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

When using this product:

• Do not exceed recommended dose
• Marked drowsiness may occur
• Avoid alcoholic drinks
• Alcohol, sedatives, and tranquilizers may increase drowsiness
• Be careful when driving a motor vehicle or operating machinery
• Excitability may occur, especially in children

Stop use and ask a doctor if:

• Nervousness, dizziness, or sleeplessness occur
• Symptoms do not improve within 7 days or occur with a fever

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 Benadryl Allergy Liquid Dosage

Children’s Benadryl Allergy Liquid Ingredient: Diphenhydramine HCl 12.5 mg/5 mL

Inactive Ingredient:

• anhydrous citric acid, D&C red no. 33, FD&C red no. 40, flavors, glycerin, monoammonium glycyrrhizinate, poloxamer 407, purified water, sodium benzoate, sodium chloride, sodium citrate, sucrose

How often can you take Children’s Benadryl Allergy Liquid:

mL = milliliter

• Take every 4 to 6 hours, or as directed by a doctor.
• Do not take more than 6 doses in 24 hours.
  • Children under 2 years: do NOT use.
  • Children 2 to 5 years: do NOT use unless directed by a doctor
  • Children 6 to 11 years: 5 mL to 10 mL

Attention: Use only the dosing cup specifically designed for use with this product. Do no use any other dosing device.

Other Information:

• Each 5 mL contains: sodium 14 mg.
• Store between 20-25° C (68-77° F).
• Protect from light. Store in outer carton until contents used.

Children’s Benadryl Allergy 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 Benadryl Allergy Liquid WARNINGS

Do NOT use

• To make a child sleepy
• With any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if you have:

• A breathing problem such as chronic bronchitis
• Glaucoma
• A sodium-restricted diet

Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers

When using this product:

• Marked drowsiness may occur
• Sedatives and tranquilizers may increase drowsiness
• Excitability may occur, especially in children

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

Children’s Benadryl Dye-Free Allergy Liquid Dosage

Children’s Benadryl Dye-Free Allergy Liquid Ingredient: Diphenhydramine HCl 12.5 mg/5 mL

Inactive Ingredient:

• Anhydrous citric acid, carboxymethylcellulose sodium, flavors, glycerin, purified water, saccharin sodium, sodium benzoate, sodium citrate, sorbitol solution

How often can you take Children’s Benadryl Dye-Free Allergy Liquid:

mL = milliliter

• Take every 4 to 6 hours, or as directed by a doctor.
• Do not take more than 6 doses in 24 hours.
  • Children under 2 years: do NOT use.
  • Children 2 to 5 years: do NOT use unless directed by a doctor
  • Children 6 to 11 years: 5 mL to 10 mL

Attention: Use only the dosing cup specifically designed for use with this product. Do no use any other dosing device.

Other Information:

• Each 5 mL contains:sodium 10 mg.
• Store between 20-25° C (68-77° F).

Children’s Benadryl Dye-Free Allergy 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 Benadryl Dye-Free Allergy Liquid WARNINGS

Do NOT use

• To make a child sleepy
• With any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if you have:

• A breathing problem such as chronic bronchitis
• Glaucoma
• A sodium-restricted diet

Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers

When using this product:

• Marked drowsiness may occur
• Sedatives and tranquilizers may increase drowsiness
• Excitability may occur, especially in children

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

Benadryl side effects

The most commonly reported side effects included somnolence, dizziness, and incoordination.

Benadryl (Diphenhydramine) may cause side effects. Numerous side effects including drowsiness, confusion, restlessness, nausea, vomiting, diarrhea, blurring of vision, diplopia, difficulty in urination, constipation, nasal stuffiness, vertigo, palpitation, headache, and insomnia ². Other side effects observed were urticaria, drug rash, photosensitivity, hemolytic anemia, hypotension, epigastric distress, anaphylactic shock, tightness of the chest and wheezing, thickening of bronchial secretions, dryness of the mouth, nose and throat and tingling, and heaviness and weakness of the hands ².

Prolonged use of antihistamines … may decrease or inhibit salivary flow, thus contributing to the development of caries, periodontal disease, oral candidiasis, and discomfort ⁸.

Tell your doctor if any of these symptoms are severe or do not go away:

• dry mouth, nose, and throat
• drowsiness
• dizziness
• nausea
• vomiting
• loss of appetite
• constipation
• increased chest congestion
• headache
• muscle weakness
• excitement (especially in children)
• nervousness

Some side effects may be serious. If you experience any of the following symptoms, call your doctor immediately:

• vision problems
• difficulty urinating or painful urination

Benadryl (Diphenhydramine) may cause other side effects. Call your doctor if you experience any unusual problems while you are taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch/default.htm)

Common side effects

The most common side effect of Benadryl is feeling sleepy and tired. This happens in more than 1 in 10 people. Talk to your doctor or pharmacist if this side effect bothers you or won’t go away.

Other common side effects of Benadryl happen in more than 1 in 100 people. Talk to your doctor or pharmacist if these side effects bother you or won’t go away:

• dry mouth
• feeling dizzy

Common side effects of Benadryl mixed with pseudoephedrine happen in more than 1 in 100 people. They include:

• difficulty sleeping
• hallucinations
• rashes
• difficulty peeing in men – especially men with an enlarged prostate

Nervous system

• Common (1% to 10%): Sedation/somnolence/sleepiness, drowsiness, unsteadiness, dizziness, headache, attention disturbance
• Rare (0.01% to 0.1%): Extrapyramidal effects, tremor, convulsions
• Frequency not reported: Paresthesia, dyskinesia/muscle dyskinesia, vertigo, neuritis, incoordination, psychomotor impairment, activation of epileptogenic foci.

Drowsiness usually diminishes after a few days.

Gastrointestinal

• Common (1% to 10%): Dry mouth
• Frequency not reported: Gastrointestinal disturbance, nausea, vomiting, constipation, diarrhea, dyspepsia, epigastric distress

Other

• Common (1% to 10%): Fatigue
• Frequency not reported: Lassitude, tinnitus, acute labyrinthitis, asthenia, chills, impaired performance (including impaired driving, work, and/or information processing)

Psychiatric

• Rare (0.01% to 0.1%): Confusion, depression, sleep disturbances
• Frequency not reported: Paradoxical excitation/excitation, agitation, increased energy, restlessness, nervousness, euphoria, anxiety, hallucinations, insomnia, irritability

Cardiovascular

• Rare (0.01% to 0.1%): Palpitations, hypotension, arrhythmia
• Frequency not reported: Tachycardia, chest tightness, extrasystoles

Hematologic

• Rare (0.01% to 0.1%): Blood disorders
• Frequency not reported: Hemolytic anemia, thrombocytopenia, agranulocytosis

Hypersensitivity

• Rare (0.01% to 0.1%): Hypersensitivity reactions
• Frequency not reported: Angioedema, anaphylactic shock

Hepatic

• Rare (0.01% to 0.1%): Liver dysfunction

Dermatologic

• Frequency not reported: Rash, urticaria, skin rashes, erythema, photosensitivity, pruritus, drug rash, excessive perspiration

Respiratory

• Frequency not reported: Dyspnea, thickening of bronchial secretions, throat tightening, wheezing, nasal stuffiness, dry nose or throat

Genitourinary

• Frequency not reported: Urinary hesitancy/difficulty/retention, dysuria, early menses

Ocular

• Frequency not reported: Blurred vision, dry eyes, diplopia

Metabolic

• Frequency not reported: Increased appetite, anorexia

Musculoskeletal

• Frequency not reported: Muscle twitching/weakness

Serious side effects

In rare cases, it’s possible to have a serious allergic reaction to Benadryl.

The warning signs of 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 Benadryl. 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.
• 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.

Benadryl overdose

Overdose occurs when someone takes more than the normal or recommended amount of this medicine. This can be by accident or on purpose.

In case of overdose, get medical help or contact a Poison Control Center helpline at 1-800-222-1222 right away!

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.

Excessive doses may cause flushing, tachycardia, blurred vision, delirium, toxic psychosis, urinary retention, and respiratory depression ⁹.

Overdosage of diphenhydramine may result in the development of anticholinergic symptoms, seizures, and coma ¹⁰. A fatal outcome following a diphenhydramine overdose does not commonly occur. This report describes an overdosage of diphenhydramine (7.5 g) which resulted in the death of a 14-year-old girl ¹⁰. The patient initially developed seizures following by cardiac conduction and hemodynamic compromise resulting in death despite life support measures.

Symptoms of Benadryl Overdose

Below are symptoms of a Benadryl (Diphenhydramine) overdose in different parts of the body ¹¹.

Bladder and Kidneys

• Inability to urinate

Eyes, ears, nose, mouth and throat

• Blurred vision
• Dry mouth
• Enlarged pupils
• Very dry eyes
• Ringing in the ears

Heart and blood vessels

• Low blood pressure
• Rapid heartbeat

Nervous system

• Agitation
• Confusion
• Seizures
• Delirium
• Depression
• Drowsiness
• Hallucinations (seeing or hearing things that aren’t there)
• Increased sleepiness
• Nervousness
• Tremor
• Unsteadiness

Skin

• Dry, red skin

Stomach and intestines

• Nausea
• Vomiting

What to Expect at the Emergency Room

Take the container to the hospital with you, if possible.

The health care provider will measure and monitor the person’s vital signs, including temperature, pulse, breathing rate, and blood pressure.

Tests that may done include ¹²:

• Blood and urine tests
• Chest x-ray
• ECG (electrocardiogram or heart tracing)

Treatment may include ¹²:

• Fluids through a vein (by IV)
• Medicines to treat symptoms
• Activated charcoal
• Laxative
• Breathing support, including a tube through the mouth into the lungs and connected to a breathing machine (ventilator)

Outlook (Prognosis)

Recovery is likely if the person survives the first 24 hours. Complications such as pneumonia, muscle damage from lying on a hard surface for a long period of time, or brain damage from lack of oxygen may result in permanent disability.

Few people actually die from an antihistamine overdose. However, serious heart rhythm disturbances may occur, which can cause death.

Keep all medicines in child-proof bottles and out of reach of children.

Case reports

A 13-month-old male who ingested 20 diphenhydramine (25 mg) tablets presented with seizures and ultimately progressed to status epilepticus and wide-complex tachycardia ¹³. Due to worsening clinical course, hemodialysis was performed with temporal resolution of his symptoms. Hemodialysis may be considered in critically ill diphenhydramine overdoses not responsive to conventional supportive care.

Case report

Diphenhydramine toxicity manifests with signs of anticholinergic toxicity; therapy is generally supportive ¹⁴. In rare cases, patients can also present with a wide complex tachycardia due to sodium channel blockade. Treatment involves sodium bicarbonate. Lidocaine and hypertonic saline are used for arrhythmias refractory to sodium bicarbonate. Although intravenous fat emulsion (IFE) therapy is proposed as an adjunctive therapy due to the lipophilicity of diphenhydramine (octanol/water partition coefficient of 3.3), successful use of intravenous fat emulsion after a confirmed sole ingestion of diphenhydramine is not previously reported. This case study ¹⁴ present the case of a 30-year-old woman presenting with seizures, a wide complex tachycardia, and cardiovascular collapse after an ingestion of diphenhydramine refractory to other therapies with rapid improvement after intravenous fat emulsion administration.

Case report

Overdosage of diphenhydramine may result in the development of anticholinergic symptoms, seizures, and coma ¹⁵. A fatal outcome following a diphenhydramine overdose does not commonly occur. This report describes /an/ overdosage of diphenhydramine (7.5 g) which resulted in the death of a 14-year-old girl. The patient initially developed seizures following by cardiac conduction and hemodynamic compromise resulting in death despite life support measures ¹⁵.

Case report

Overdosage and toxicity (including death) have been reported in children younger than 2 years of age receiving nonprescription (over-the-counter, OTC) preparations containing antihistamines, cough suppressants, expectorants, and nasal decongestants alone or in combination for relief of symptoms of upper respiratory tract infection ¹. There is limited evidence of efficacy for these preparations in this age group, and appropriate dosages (i.e., approved by the US Food and Drug Administration [FDA]) for the symptomatic treatment of cold and cough have not been established ¹. Therefore, FDA stated that nonprescription cough and cold preparations should not be used in children younger than 2 years of age; the agency continues to assess safety and efficacy of these preparations in older children. Meanwhile, because children 2-3 years of age also are at increased risk of overdosage and toxicity, some manufacturers of oral nonprescription cough and cold preparations recently have agreed to voluntarily revise the product labeling to state that such preparations should not be used in children younger than 4 years of age. Because FDA does not typically request removal of products with previous labeling from pharmacy shelves during a voluntary label change, some preparations will have the new recommendation (“do not use in children younger than 4 years of age”), while others will have the previous recommendation (“do not use in children younger than 2 years of age”). FDA recommends that parents and caregivers adhere to the dosage instructions and warnings on the product labeling that accompanies the preparation if administering to children and consult with their clinician about any concerns.

Case report

Two cases of diphenhydramine-containing hypnotics overdose, exhibiting delirium and involuntary choreic movement were identified ¹⁶. In case 1, a 32-year-old man ingested 24 tablets of Drewell, each containing 25 mg diphenhydramine, in a suicidal attempt. About four hours after ingestion, he showed generalized convulsion, delirium, and involuntary choreic movements ¹⁶. Intravenous diazepam was ineffective and he was sedated with continuous infusion of propofol. About 15 hours after ingestion and on discontinuing the sedation, he became alert and did not show any neurological abnormality. The blood concentration of diphenhydramine, measured by liquid chromatography/electrospray mass spectrometry, was 1.26 ug/ mL. In case 2, a 24-year-old woman ingested 114 tablets of Drewell and was admitted to a hospital ¹⁶. Her consciousness was impaired and she was treated with intravenous fluids. About four hours after ingestion, she became restless and showed confusion, agitation, and involuntary choreic movements ¹⁶. Sedation with continuous propofol infusion was required. She awoke the next day on discontinuing the sedation, and she did not show any neurological abnormalities. The blood concentration of diphenhydramine was 2.37 ug/mL. It is suggested that physicians should be aware of psychotic-like symptoms and choreic involuntary movement in patients with diphenhydramine-containing hypnotics overdose ¹⁶.

Case report

A 13-month-old infant girl was brought in by the emergency medical service for a witnessed tonic-clonic seizure ¹⁷. Two hours previously, the child had been found with an open bottle of 25-mg diphenhydramine tablets, 24 of which were missing. Midazolam was administered with seizure resolution ¹⁷. Examination revealed 4-mm reactive pupils; nystagmus; warm, dry, flushed skin; and altered mental status. Initial electrocardiograms revealed sinus tachycardia at a rate of 180 beats per minute, a prolonged QRS of 130 milliseconds (from a baseline of 65 milliseconds), and a positive terminal R wave in aVR, which later resolved after sodium bicarbonate treatment. The patient was discharged home the following day with no sequelae ¹⁷.

Case report

A 36-year-old woman with a medical history of hypothyroidism on levothyroxine was brought to the emergency department with active seizures by emergency medical services after what was later determined to be a diphenhydramine overdose ¹⁸. One hour after an argument with her husband he found her lethargic in a locked room. Initial vital signs were: blood pressure, 90/55 mmHg; heart rate, 160 beats/min; respiratory rate 18 breaths/min; room air oxygen saturation, 99%; temperature, 99.8 deg F; rapid point-of-care glucose, 130 mg/dL. The generalized seizures continued for duration of 30 min, despite the intravenous administration of 8 mg of lorazepam. The patient underwent endotracheal intubation and a propofol infusion terminated her seizures. An electrocardiogram after the status was terminated which revealed a wide-complex tachycardia with QRS duration of 127 ms. The QRS narrowed after 200 mEq of intravenous sodium bicarbonate was administrated. The patient was neurologically intact upon extubation on hospital day 2. The serum diphenhydramine concentration drawn on arrival to the ED was 1200 ng/mL (9-120 ng/mL); a tricyclic screen was negative. While seizures and sodium channel blockade are recognized complications of diphenhydramine toxicity, reported cases of status epilepticus from diphenhydramine overdose are rare. Elements of the patient’s presentation were similar to a tricyclic overdose and management required aggressive control of her seizures, sodium bicarbonate therapy, and recognizing that physostigmine was contraindicated due to wide complex tachycardia. Diphenhydramine overdose may cause status epilepticus and wide-complex tachycardia. Management should focus on antidotal therapy with sodium bicarbonate and supportive neurological management with appropriate anticonvulsants and airway protection if clinically indicated ¹⁸.

Case report

Drug- and toxin-induced rhabdomyolysis is a nonspecific clinical syndrome resulting from the release of skeletal muscle cell contents into the plasma and urine. Antihistamine drugs are the active ingredients in a number of over-the-counter preparations and are frequently ingested in suicide attempts. The authors report rhabdomyolysis as a rare adverse effect of diphenhydramine toxicity in a 29-year-old man who ingested an unknown quantity of an over-the-counter sleep preparation in a suicide attempt ¹⁹. The patient had documented toxic concentration of diphenhydramine in his cerebrospinal fluid and no history of seizures, coma, or hypothermia. A high index of suspicion and an evaluation for rhabdomyolysis is warranted in antihistamine toxicity.

Case report

A case of electrocardiographic signature of the Brugada syndrome: a genetic condition that causes disruption of the heart’s normal rhythm in a 39-year-old patient with an overdose of diphenhydramine is reported ²⁰. He was found unconscious and hypotensive. His serum potassium concentration was 8.3 mEq/L and the ECG revealed a coved-type ST-segment elevation in leads V2-V3. These repolarization abnormalities neither normalize with the correction of the hyperkalemia nor with an intravenous infusion of isoproterenol. When he regained consciousness, he was admitted the toxic ingestion of diphenhydramine and progressively the ECG normalized. A negative flecainide test confirmed that the transient ECG abnormalities were the consequence of the drug overdose and ruled out the Brugada syndrome ²⁰.

Case report

Diphenhydramine it can cause paradoxical central nervous system stimulation in children, with effects ranging from excitation to seizures and death ²¹. Reports of fatal intoxications in young children are rare. The authors present five cases of fatal intoxication in infants 6, 8, 9, 12, and 12 weeks old ²¹. Postmortem blood diphenhydramine levels in the cases were 1.6, 1.5, 1.6, 1.1 and 1.1 mg/L, respectively. Anatomic findings in each case were normal. In one case the child’s father admitted giving the infant diphenhydramine in an attempt to induce the infant to sleep; in another case, a daycare provider admitted putting diphenhydramine in a baby bottle ²¹. Two cases remain unsolved; one case remains under investigation. The postmortem drug levels in these cases are lower than seen in adult fatalities ²¹.

Case report

Diphenhydramine toxicity (e.g., dilated pupils, facial flushing, hallucinations, ataxic gait, urinary retention) has been reported in pediatric patients (19 months to 9 years of age) following topical application of diphenhydramine to large areas of the body (often areas with broken skin) or following concomitant use of topical and oral preparations containing the drug for self-medication in the symptomatic management of pain and pruritus associated with varicella (chickenpox), poison ivy, or sunburn ¹. Manifestations typically resolved within 48 hours following discontinuance of the drug, and no deaths have been reported following topical use of diphenhydramine alone.

1. American Society of Health-System Pharmacists 2013; Drug Information 2013. Bethesda, MD. 2013, p. 10
2. Troy, D.B. (Ed); Remmington The Science and Practice of Pharmacy. 21 st Edition. Lippincott Williams & Williams, Philadelphia, PA 2005, p. 1545
3. Brunton, L. Chabner, B, Knollman, B. Goodman and Gillman’s The Pharmaceutical Basis of Therapeutics, Twelth Edition, McGraw Hill Medical, New York, NY. 2011, p. 923
4. Benzodiazepines. https://mothertobaby.org/fact-sheets/benzodiazepines-pregnancy/pdf/
5. Ito S, Blajchman A, Stephenson M et al. Prospective follow-up of adverse reactions in breast-fed infants exposed to maternal medication. Am J Obstet Gynecol. 1993;168:1393-9. https://www.ncbi.nlm.nih.gov/pubmed/8498418
6. 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
7. 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
8. USP Convention. USPDI – Drug Information for the Health Care Professional. 15 th ed. Volume 1. Rockville, MD: United States Pharmacopeial Convention, Inc., 1995. (Plus updates.), p. 306
9. OLSON, K.R. (Ed). Poisoning and Drug Overdose, Sixth Edition. McGraw-Hill, New York, NY 2012, p. 478
10. Krenzelok EP et al; Ann Emerg Med 11 (4): 212-3; 1982 https://www.ncbi.nlm.nih.gov/pubmed/7073039
11. Aronson JK. Anticholinergic drugs. In: Aronson JK, ed. Meyler’s Side Effects of Drugs. 16th ed. Waltham, MA: Elsevier; 2016:534-539.
12. Monte AA, Hoppe JA. Anticholinergics. In: Walls RM, Hockberger RS, Gausche-Hill M, eds. Rosen’s Emergency Medicine: Concepts and Clinical Practice. 9th ed. Philadelphia, PA: Elsevier; 2018:chap 145.
13. McKeown NJ, West PL, Hendrickson RG, Horowitz BZ. Survival after Diphenhydramine Ingestion with Hemodialysis in a Toddler. Journal of Medical Toxicology. 2011;7(2):147-150. doi:10.1007/s13181-010-0116-4. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3724430/
14. Life-threatening diphenhydramine toxicity presenting with seizures and a wide complex tachycardia improved with intravenous fat emulsion. Am J Ther. 2014 Nov-Dec;21(6):542-4. doi: 10.1097/MJT.0b013e318281191b. https://www.ncbi.nlm.nih.gov/pubmed/24096706
15. Massive diphenhydramine overdose resulting in death. Ann Emerg Med. 1982 Apr;11(4):212-3. https://www.annemergmed.com/article/S0196-0644(82)80501-5/pdf
16. [Diphenhydramine poisoning presented with psychotic-like symptoms and choreic involuntary movement: report of two cases]. Chudoku Kenkyu. 2007 Apr;20(2):125-9. https://www.ncbi.nlm.nih.gov/pubmed/17533963
17. Wide complex tachycardia in a pediatric diphenhydramine overdose treated with sodium bicarbonate. Pediatr Emerg Care. 2011 Dec;27(12):1175-7. doi: 10.1097/PEC.0b013e31823b0e47 https://www.ncbi.nlm.nih.gov/pubmed/22158278
18. JANG DH, MANINI AF, TRUEGER NS, et al. Status epilepticus and wide-complex tachycardia secondary to diphenhydramine overdose. Clinical toxicology (Philadelphia, Pa). 2010;48(9):945-948. doi:10.3109/15563650.2010.527850. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4091778/
19. Emadian SM et al; Am J Emerg Med 14 (6): 574-6; 1996 https://www.ncbi.nlm.nih.gov/pubmed/8857809
20. Lopez-Barbeito B et al; Pacing Clin Electrophysiol 28 (7): 730-2;2005 https://www.ncbi.nlm.nih.gov/pubmed/16008813
21. Baker AM et al; J Forensic Sci 48 (2): 425-8;2003 https://www.ncbi.nlm.nih.gov/pubmed/12665005

What is alka seltzer

Alka Seltzer is a medicine that contains the following active ingredients: Anhydrous Citric Acid 1000mg (antacid), Aspirin 325mg (an analgesic – nonsteroidal anti-inflammatory drug) and Sodium Bicarbonate 1916mg (baking soda – antacid). Alka-Seltzer is used for the relief of heartburn, upset stomach, acid indigestion with headache and body aches.

In Alka Seltzer Extra Strength the active ingredients are: Anhydrous Citric Acid 1000mg (antacid), Aspirin 500mg (an analgesic – nonsteroidal anti-inflammatory drug) and Sodium Bicarbonate 1985mg (baking soda – antacid).

In Alka Seltzer Extra Strength Heartburn Relief Chews the active ingredient is: Calcium Carbonate 750mg (antacid).

Other information:

• each Alka Seltzer tablet contains: sodium 567 mg
• store at room temperature. Avoid excessive heat.
• Alka-Seltzer in water contains principally the antacid sodium citrate and the analgesic sodium acetylsalicylate

Inactive ingredients:

• none

There is another type of Alka Seltzer medicine called “Alka Seltzer – Heartburn” that contains only Anhydrous citric acid 1000 mg (antacid) and Sodium bicarbonate (heat-treated) 1940 mg (antacid) without the added Aspirin. The directions of use and dosage is the same as the standard Alka Seltzer, except it contains phenylalanine 5.6 mg per tablet which is contraindicated for people with phenylketonuria.

Alka seltzer uses

Alka Seltzer main uses are for:

• heartburn, acid indigestion, and sour stomach when accompanied with headache or body aches and pains
• upset stomach with headache from overindulgence in food or drink
• headache, body aches, and pain alone

How often can you take alka seltzer

Directions of use of standard Alka Seltzer:

Fully dissolve 2 tablets in 4 ounces of water before taking

• Children under 12 years: Consult a doctor for advice
• Adults and children 12 years and over: take 2 tablets every 4 hours, or as directed by a doctor. Do not exceed 8 tablets in 24 hours
• Adults 60 years and over: take 2 tablets every 4, or as directed by a doctor. Do not exceed 4 tablets in 24 hours

For Alka Seltzer Extra Strength:

Fully dissolve 2 tablets in 4 ounces of water before taking

• Children under 12 years: Consult a doctor for advice
• Adults and children 12 years and over: take 2 tablets every 6 hours, or as directed by a doctor. Do not exceed 7 tablets in 24 hours
• Adults 60 years and over: take 2 tablets every 6 hours, or as directed by a doctor. Do not exceed 3 tablets in 24 hours.

Alka Seltzer Extra Strength Heartburn Relief Chews

• Children under 12 years: Consult a doctor for advice
• Adults and children 12 years and over: fully chew then swallow 1 or 2 chewable tablets as symptoms occur, or as directed by a doctor. Do not exceed exceed 5 chewable tablets in 24 hours
• Do not use the maximum dosage of this product for more than 2 weeks except under the advice and supervision of a physician
• Each chewable tablet contains calcium 300mg.
• Constipation may occur.

How does alka seltzer work

When too much acid builds up in your stomach, it can feel upset. Alka-Seltzer is an antacid or “buffer” which neutralizes stomach acid keeping your stomach from being too acidic.

Alka Seltzer Side Effects

Do NOT use

• if you are allergic to aspirin or any other pain reliever/fever reducer
• if you have ever had an allergic reaction to this product or any of its ingredients

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

Aspirin may cause a severe allergic reaction which may include:

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

Stomach bleeding warning

This product contains Aspirin which is a 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

Ask a doctor before use if:

• 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 a sodium-restricted diet

Ask a doctor or pharmacist before use if you are:

• presently taking a prescription drug. Antacids may interact with certain prescription drugs.
• taking a prescription drug for diabetes, gout, or arthritis.

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
• symptoms get worse or last more than 10 days
• redness or swelling is present
• ringing in the ears or a loss of hearing occurs
• new symptoms occur

Alka seltzer pregnant

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

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.

Keep out of reach of children.

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

What is motrin

Motrin is a medicine that contains a nonsteroidal anti-inflammatory drug (NSAID) – Ibuprofen and is available over-the-counter to relieve pain and reduce fever. Motrin (ibuprofen) is a nonsteroidal anti-inflammatory drug (NSAID) used to treat mild to moderate pain, fever and pain caused by inflammation. Motrin helps to relieve symptoms of arthritis (osteoarthritis, rheumatoid arthritis, or juvenile arthritis), such as inflammation, swelling, stiffness, and joint pain. Motrin does not cure arthritis and will help you only as long as you continue to take it. In addition, ibuprofen can be used to treat fever, menstrual cramps, and other conditions as determined by your doctor.

Motrin works on one of the chemical pathways for pain. It 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.

Motrin PM combines both ibuprofen (NSAID) with an antihistamine – Diphenhydramine – that reduces the effects of natural chemical histamine in your body. Motrin PM is a combination medicine used to treat occasional insomnia associated with minor aches and pains. Motrin PM is not for use in treating sleeplessness without pain, or sleep problems that occur often.

What is Motrin used for?

Motrin can be used for the short-term relief of fever, mild to moderate pain and inflammation (redness, swelling and soreness).

Motrin 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.
• Motrin 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 Motrin provides only temporary relief – it won’t cure your condition.

Motrin PM combines both ibuprofen (NSAID) with an antihistamine – Diphenhydramine – that reduces the effects of natural chemical histamine in your body.

Motrin PM is a combination medicine used to treat occasional insomnia associated with minor aches and pains.

Motrin 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 (Motrin 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 (Motrin 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.

Motrin vs Ibuprofen

Motrin IB contains ibuprofen – an ingredient that provides powerful pain relief.

Motrin PM combines both ibuprofen (NSAID) with an antihistamine – Diphenhydramine, which provides powerful pain relief and helps you fall asleep and stay asleep.

How long does it take for Motrin to work?

You should start to feel better 20 to 30 minutes after taking Motrin (ibuprofen) by mouth.

For some types of long-term pain, you’ll need to take Motrin (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 Motrin with other painkillers

It’s safe to take Motrin (ibuprofen) with acetaminophen or codeine.

But don’t take Motrin (ibuprofen) with similar painkillers like aspirin or naproxen (Aleve) without talking to a doctor.

Motrin (ibuprofen), aspirin and naproxen belong to the same group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). If you take them together, Motrin (ibuprofen) plus aspirin or naproxen may increase the chance of you getting side effects like stomach ache.

Alternatives to Motrin

For treating fever, an alternative to Motrin (ibuprofen) is acetaminophen (Tylenol).

For pain or inflammation-related swelling, ask your doctor or pharmacist for an alternative if Motrin (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 Motrin (ibuprofen) in the same tablet.

If your pain is severe, your doctor may prescribe you a stronger pain reliever.

Is Motrin better than acetaminophen or aspirin?

Motrin (ibuprofen), acetaminophen (paracetamol) and aspirin are all effective painkillers.

Motrin (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 Motrin (ibuprofen) for headaches, toothache, sprains, stomach ache, and nerve pain like sciatica.

Aspirin works in a similar way to Motrin (ibuprofen). Like Motrin (ibuprofen), it’s good for period pain and migraines. (If you have heavy periods, it can make them heavier.)

How long will I take Motrin tablets for?

If you’re taking Motrin (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 Motrin (ibuprofen) for longer if you have a long-term health problem, such as rheumatoid arthritis.

If you need to take Motrin (ibuprofen) for more than 6 months, your doctor may prescribe a medicine to protect your stomach from any side effects.

Can I take Motrin for a long time?

It’s safe to take Motrin (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 Motrin (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 Motrin cause stomach ulcers?

Motrin (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 Motrin (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 Motrin?

It’s usually safe to drink alcohol while taking Motrin (ibuprofen). But if you’re taking Motrin (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 Motrin (ibuprofen).

It’s best to take Motrin (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 Motrin doesn’t work?

If Motrin (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.

Motrin (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 Motrin affect my fertility?

Taking Motrin (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 Motrin (ibuprofen).

Don’t take Motrin (ibuprofen) tablets, capsules or syrup if you’re trying for a baby. Acetaminophen (Paracetamol) is a better option.

Will Motrin affect my contraception?

Motrin (ibuprofen) – by mouth or on your skin – doesn’t affect any contraceptives, including the contraceptive pill and the morning after pill.

Pregnancy and breastfeeding

Motrin (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 Motrin (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 ¹.

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 ². 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 ². 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 ². 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 ².

Motrin (ibuprofen) and breastfeeding

Motrin (ibuprofen) is safe to take by mouth if you are breastfeeding.

Two early studies attempted measurement of ibuprofen in milk ³, ⁴. 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) ³, ⁴.

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 ⁵ 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 ⁶.

How should Motrin be used?

Prescription Motrin (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 Motrin (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 Motrin (ibuprofen) every 4 to 6 hours as needed for pain or fever. Children and infants may usually be given nonprescription Motrin (ibuprofen) every 6 to 8 hours as needed for pain or fever, but should not be given more than 4 doses in 24 hours. Motrin (ibuprofen) may be taken with food or milk to prevent stomach upset. If you are taking Motrin (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 Motrin (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.

Motrin (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 Motrin (ibuprofen), you should be careful not to take any nonprescription medications that also contain Motrin (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 Motrin (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 Motrin (ibuprofen) or a combination product that contains Motrin (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 Motrin (ibuprofen) products that are made for adults to children.

Before you give an Motrin (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 Motrin (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 Motrin (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 Motrin (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 Motrin (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 Motrin

Motrin (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 Motrin

• tell your doctor and pharmacist if you are allergic to Motrin (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 Motrin (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 Motrin (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 Motrin (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 Motrin (ibuprofen), call your doctor.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking Motrin (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 Motrin (ibuprofen). Some types of nonprescription Motrin (ibuprofen) may be sweetened with aspartame, a source of phenylalanine.

Motrin dosage chart

A few reminders:

• When taking any medicine, always read and follow the label carefully.
• Always keep the outer carton of Motrin products.
• These ibuprofen dosage directions are for adults and children 12 years and older.
• Do not take more than directed.

Motrin IB Caplets Directions of use

• do not take more than directed
• the smallest effective dose should be used

Uses:

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

Table 1. Motrin IB Caplets

Motrin IB Caplets Active ingredients (in each caplet):

1. Ibuprofen 200 mg (NSAID)/Purpose: Pain reliever and fever reducer

Inactive ingredients:

• carnauba wax, colloidal silicon dioxide, FD&C yellow no.6, hypromellose, iron oxide, magnesium stearate, modified starch, polydextrose, polyethylene glycol, pregelatinized starch, propylene glycol, shellac, stearic acid, titanium dioxide

or

• colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C red no. 40 aluminum lake, FD&C yellow no. 6 aluminum lake, iron oxides, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, stearic acid, talc, titanium dioxide.

Other instructions:

• read all warnings and directions before use. Keep carton.
• store between 20-25°C (68-77°F)

Motrin IB Liquid Gels Directions of use

• do not take more than directed
• the smallest effective dose should be used

Uses:

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

Table 2. Motrin IB Liquid Gels

Motrin IB Liquid Gels Active ingredients (in each caplet):

1. Active ingredient (in each capsule): Solubilized ibuprofen equal to 200 mg ibuprofen (NSAID) (present as the free acid and potassium salt)/Pain reliever and fever reducer

Inactive ingredients:

• gelatin, pharmaceutical ink, polyethylene glycol, potassium hydroxide, purified water, sorbitan and sorbitol

Other instructions:

• each capsule contains: potassium 20 mg
• store between 20-25ºC (68-77ºF)
• avoid excessive heat above 40ºC (104ºF). Protect from light.

Motrin PM Caplets Directions of use

• do not take more than directed
• adults and children 12 years and over: take 2 caplets at bedtime
• do not take more than 2 caplets in 24 hours

Uses:

• for relief of occasional sleeplessness when associated with minor aches and pains
• helps you fall asleep and stay asleep

Table 3. Motrin PM Caplets

MOTRIN® PM Caplets Active ingredients (in each caplet):

1. Diphenhydramine citrate 38 mg/Purpose: Nighttime sleep-aid
2. Ibuprofen 200 mg (NSAID)/Purpose: Pain reliever and fever reducer

Inactive ingredients:

• colloidal silicon dioxide, croscarmellose sodium, glyceryl behenate, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc, titanium dioxide

Other instructions:

• 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)

Children’s Motrin Directions of use

• this product does not contain directions or complete warnings for adult use
• do not give more than directed
• shake well before using
• mL=milliliter
• find right dose on chart below. If possible, use weight to dose; otherwise use age.
• use only enclosed dosing cup. Do not use any other dosing device.
• if needed, repeat dose every 6-8 hours
• do not use more than 4 times a day
• replace original bottle cap to maintain child resistance

Uses:

• Temporarily relieves minor aches and pains due to the common cold, flu, sore throat, headache and toothache
• Reduces fever

Table 4. Children’s Motrin

*or as directed by a doctor.

Children’s Motrin Active ingredients:

• Active ingredient (in each 5 mL): Ibuprofen 100 mg (NSAID)/ Purpose: Pain reliever/fever reducer

Inactive ingredients:

• Bubble Gum: acesulfame potassium, anhydrous citric acid, FD&C red no. 40, flavors, glycerin, polysorbate 80, pregelatinized starch, purified water, sodium benzoate, sucrose, xanthan gum
• Grape: acesulfame potassium, anhydrous citric acid, D&C red no. 33, FD&C blue no. 1, FD&C red no. 40, flavors, glycerin, polysorbate 80, pregelatinized starch, purified water, sodium benzoate, sucrose, xanthan gum
• Berry: acesulfame potassium, anhydrous citric acid, D&C yellow no. 10, FD&C red no. 40, flavors, glycerin, polysorbate 80, pregelatinized starch, purified water, sodium benzoate, sucrose, xanthan gum
• Dye-Free Berry: acesulfame potassium, anhydrous citric acid, flavors, glycerin, polysorbate 80, pregelatinized starch, purified water, sodium benzoate, sucrose, xanthan gum

Other instructions:

• each 5 mL contains: sodium 2 mg
• store between 20-25°C (68-77°F)

Infants’ Motrin Directions of use

• this product does not contain directions or complete warnings for adult use
• do not give more than directed
• shake well before using
• find right dose on chart below. If possible, use weight to dose; otherwise use age.
• mL=milliliter
• measure with the dosing device provided. Do not use with any other device.
• dispense liquid slowly into the child’s mouth, toward the inner cheek
• if needed, repeat dose every 6-8 hours
• do not use more than 4 times a day

Uses:

• Temporarily relieves minor aches and pains due to the common cold, flu, sore throat, headaches and toothaches
• Reduces fever

Table 5. Infants’ Motrin Dosage

Infants’ Motrin Active ingredients:

• Active ingredient (in each 1.25 mL): Ibuprofen 50mg (NSAID)/ Purpose: Pain reliever/fever reducer

Inactive ingredients:

• Berry: anhydrous citric acid, caramel, FD&C red no. 40, flavors, glycerin, polysorbate 80, pregelatinized starch, purified water, sodium benzoate, sorbitol solution, sucrose, xanthan gum
• Dye-Free Berry: anhydrous citric acid, caramel, flavors, glycerin, polysorbate 80, pregelatinized starch, purified water, sodium benzoate, sorbitol solution, sucrose, xanthan gum

Other instructions:

• store between 20-25°C (68-77°F)

Motrin side effects

Common side effects

The common side effects of Motrin (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 Motrin (ibuprofen) when you are over 65, or have an ulcer, so discuss this with your doctor. Motrin (ibuprofen), like all NSAIDs, can also make heart disease worse – talk to your doctor before taking Motrin (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

Motrin (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 Motrin (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 Motrin (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 Motrin (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.

Motrin IB Side Effects

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

Motrin IB 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

Heart attack and stroke warning

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 have ever had an allergic reaction to ibuprofen or any other pain reliever/fever reducer
• right before or after heart surgery

Ask a doctor before use if:

• you have problems or serious side effects from taking pain relievers or fever reducers
• 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, kidney disease, asthma, or had a stroke
• you are taking a diuretic

Ask a doctor or pharmacist before use if you are:

• taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
• 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

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
• you have symptoms of heart problems or stroke:
  • chest pain
  • trouble breathing
  • weakness in one part or side of body
  • slurred speech
  • leg swelling
• 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

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.

Motrin IB Liquid Gels Side Effects

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 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

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 have ever had an allergic reaction to any other pain reliever/fever reducer
• right before or after heart surgery

Ask a doctor before use if:

• you have problems or serious side effects from taking pain relievers or fever reducers
• 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, kidney disease, asthma, or had a stroke
• you are taking a diuretic

Ask a doctor or pharmacist before use if you are:

• taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
• 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

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
• you have symptoms of heart problems or stroke:
  • chest pain
  • trouble breathing
  • weakness in one part or side of body
  • slurred speech
  • leg swelling
• 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

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.

Children’s Motrin Side Effects

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 NSAID, which may cause severe stomach bleeding. The chance is higher if your 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

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.

Sore throat warning

Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea and vomiting may be serious. Consult doctor promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by doctor.

Do NOT use

• if the child has ever had an allergic reaction to ibuprofen or any other pain reliever/fever reducer
• right before or after heart surgery

Ask a doctor before use if:

• stomach bleeding warning applies to your child
• child has a history of stomach problems, such as heartburn
• child has problems or serious side effects from taking pain relievers or fever reducers
• child has not been drinking fluids
• child has lost a lot of fluid due to vomiting or diarrhea
• child has high blood pressure, heart disease, liver cirrhosis, kidney disease, or had a stroke
• child has asthma
• 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

When using this product:

• take with food or milk if stomach upset occurs

Stop use and ask a doctor if:

• child experiences any of the following signs of stomach bleeding:
  • feels 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
• the child does not get any relief within the 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

Infants’s Motrin Side Effects

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 NSAID, which may cause severe stomach bleeding. The chance is higher if your 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

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.

Sore throat warning

Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea and vomiting may be serious. Consult doctor promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by doctor.

Do NOT use

• if the child has ever had an allergic reaction to ibuprofen or any other pain reliever/fever reducer
• right before or after heart surgery

Ask a doctor before use if:

• stomach bleeding warning applies to your child
• child has a history of stomach problems, such as heartburn
• child has problems or serious side effects from taking pain relievers or fever reducers
• child has not been drinking fluids
• child has lost a lot of fluid due to vomiting or diarrhea
• child has high blood pressure, heart disease, liver cirrhosis, kidney disease, or had a stroke
• child has asthma
• 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

When using this product:

• take with food or milk if stomach upset occurs

Stop use and ask a doctor if:

• child experiences any of the following signs of stomach bleeding:
  • feels 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
• the child does not get any relief within the 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

Motrin PM Side Effects

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 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

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 have ever had an allergic reaction to any other pain reliever/fever reducer
• unless you have time for a full night’s sleep
• in children under 12 years of age
• right before or after heart surgery
• with any other product containing Diphenhydramine, even one used on skin
• if you have sleeplessness without pain

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
• you have a breathing problem such as emphysema or chronic bronchitis
• you have glaucoma
• you have trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are:

• taking sedatives or tranquilizers, or any other sleep-aid
• under a doctor’s care for any continuing medical illness
• taking any other antihistamines
• taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
• taking any other drug

When using this product:

• drowsiness will occur
• avoid alcoholic drinks
• do not drive a motor vehicle or operate machinery
• take with food or milk if stomach upset occurs

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
• you have symptoms of heart problems or stroke:
  • chest pain
  • trouble breathing
  • weakness in one part or side of body
  • slurred speech
  • leg swelling
• pain gets worse or lasts more than 10 days
• sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.
• redness or swelling is present in the painful area
• any new symptoms appear

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.

Diphenhydramine and ibuprofen may pass into breast milk and may harm a nursing baby. Antihistamines may also slow breast milk production. Do not use this medicine without a doctor’s advice if you are breast-feeding a baby.

This medicine is not approved for use by anyone younger than 12 years old. Always ask a doctor before giving an antihistamine to a child. Death can occur from the misuse of antihistamines in very young children.

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 ⁷. 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 ⁷.

Fatal autoimmune hemolytic anemai occurred coincident with oral administration of ibuprofen 400 mg 3 times per day in 49 yr old male ⁸.

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 ⁹.

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 ¹⁰.

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 ¹¹.

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 ¹². 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 ¹². 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 ¹².

In a series of 293 patients treated during a five year period no visual symptoms were detected that were thought attributable to the drug ¹² 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 ¹².

Chemically induced renal dysfunction caused by ibuprofen is dose/duration related ¹³. 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 ¹⁴. This study ¹⁴ 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 ¹⁴ 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 ¹⁴.

Motrin overdose

Can you overdose on Motrin? Yes

In case of Motrin 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 Motrin 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.

1. Stockton, D.L. and A.S. Paller. J Am Acad Dermatol 23 (1):87-103; 1990
2. J Toxicol Clin Toxicol 2003;41(4):551-2
3. 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
4. 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
5. Walter K, Dilger C. Ibuprofen in human milk. Br J Clin Pharmacol. 1997;44:211-2
6. 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
7. 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
8. GUIDRY JB ET AL; JAMA 242 (JUL 6): 68; 1979 https://jamanetwork.com/journals/jama/article-abstract/365628
9. WARRINGTON SJ ET AL; RHEUMATOLOGY 7 (NEW TRENDS OSTEOARTHRITIS): 107;1982
10. COURT H ET AL; HUM TOXICOL 2 (2): 381; 1983 https://www.ncbi.nlm.nih.gov/pubmed/6862484
11. Lortholary A et al; Rev Med Interne 11 (3): 243-4; 1990 https://www.ncbi.nlm.nih.gov/pubmed/2096424
12. Grant, W.M. Toxicology of the Eye. 3rd ed. Springfield, IL: Charles C. Thomas Publisher, 1986., p. 506
13. 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
14. Head JE et al; Bone 29 (5): 437-41; 2001 https://www.ncbi.nlm.nih.gov/pubmed/11704495

What is pedialyte

Pedialyte is an oral rehydration solution that is used to add back fluid after fluid loss or to help prevent fluid and electrolyte problems. Pedialyte is a medical-grade hydration solution specially formulated with the optimal balance of sugar and electrolytes needed to help replenish vital fluids, minerals, and nutrients, which, when lost, can lead to dehydration ¹. Pedialyte (oral rehydration solution) main purpose is to rehydrate your body from all sorts of dehydration causes. Both adults and kids can use Pedialyte for rehydration. Rehydrating with Pedialyte helps everyone with dehydration due to diarrhea and vomiting—adults and kids to feel better fast. For example, most people will experience diarrhea — loose watery stools — at some time in their life. Most people do not need any specific treatment for infectious diarrhea as it usually improves on its own in a couple of days. However, it is important to drink plenty of liquids to keep well hydrated. This is especially important for children and babies. Dehydration happens when you haven’t got enough fluids in your body. Dehydration means your body loses more fluids than you take in. If it isn’t treated it can get worse and become a serious problem. If severe, dehydration can cause serious problems.

Children under 5s should get plenty of fluids to avoid dehydration. It’s quite common for young children to become dehydrated. It can be serious if it’s not dealt with quickly. The body needs to have enough fluid to be able to function at its best. Children are at risk of dehydration, especially in hot weather and when they are exercising. By the time they feel thirsty, they are probably already dehydrated – so it’s up to parents and carers to make sure they are drinking enough.

What does your child need to stay well hydrated?

• Water is the best choice for children.
• Avoid sports drinks, fruit juices, soft drinks and flavoured mineral waters since they all contain sugar, which can lead to tooth decay.

The recommended daily intake of water for children is:

• 5 to 8 years old: 5 glasses (1 liter)
• 9 to 12 years old: 7 glasses (1.5 liters)
• 13 years old and over: 8 to 10 glasses (2 liters).

Children need even more water when they are exercising. Your child should drink before, during and after physical activity – even if they aren’t thirsty.

Tips to help your child stay hydrated

• make sure they always pack a water bottle
• choose water rather than sugary drinks
• remind them to drink before a sports game
• encourage them to have a few mouthfuls of water during any breaks in the game
• make sure they have a big drink afterwards to make up for any sweat they have lost.

Mild dehydration can be treated by giving your child more to drink. But serious dehydration – for example, if they are unwell – can be very serious. It’s important to know what to look out for.

How does pedialyte work?

Oral rehydration solutions like Pedialyte are specifically designed fluids that contain an appropriate amount of sodium, glucose and other electrolytes and are of the appropriate osmolality, to maximize water absorption from the gut. They use the principle of glucose-facilitated sodium transport whereby glucose enhances sodium and secondarily water transport across the mucosa of the upper intestine ². The sodium and glucose concentrations and the osmolality are of vital importance.

The World Health Organisation (WHO) recommends an oral rehydration solution that has a sodium concentration of 60-90mmol/L ³.

The total substance concentration (including that contributed by glucose) should be within the range of 200-310 mmol/l.

Table 1. World Health Organisation (WHO) recommends an oral rehydration solution

New formula oral rehydration salts

A new formula for oral rehydration salts (ORS), has been released by the World Health Organization ³. The new formula oral rehydration salts (ORS), a sodium and glucose solution is widely used to treat children with acute diarrhea.

The new improved formula is the result of extensive research sponsored by WHO’s Department of Child and Adolescent Health and Development and supported by the United States Agency for International Development (USAID). The latest study was conducted in five developing countries among children from one month to two years old with acute diarrhoea and dehydration.

The study’s findings suggest that using the low-sodium, low-glucose ORS formulation reduces the need for intravenous fluids by 33 percent. The effect of this reduction could result in fewer children requiring hospitalization, fewer secondary infections, a diminished need to handle blood with its potentially dangerous consequences, and lower health care costs.

For the past 20 years, numerous studies have been undertaken to develop an “improved” oral rehydration solution. The goal was a product that would be at least as safe and effective as standard oral rehydration solution for preventing or treating dehydration from all types of diarrhoea but which, in addition, would reduce stool output or have other important clinical benefits. One approach has consisted in reducing the osmolarity of oral rehydration salts (ORS) solution to avoid possible adverse effects of hypertonicity on net fluid absorption. This was done by reducing the solution’s glucose and salt (NaCl) concentrations.

Studies to evaluate this approach were reviewed at a consultative technical meeting held in New York and technical recommendations were made to WHO and UNICEF on the efficacy and safety of reduced osmolarity oral rehydration salts (ORS) in children with acute non-cholera diarrhoea, and in adults and children with cholera.

These studies showed that the efficacy of oral rehydration salts (ORS) solution for treatment of children with acute non-cholera diarrhoea is improved by reducing its sodium concentration to 75 mEq/l, its glucose concentration to 75 mmol/l, and its total osmolarity to 245 mOsm/l. The need for unscheduled supplemental IV therapy in children given this solution was reduced by 33%. In a combined analysis of this study and studies with other reduced osmolar-ity Oral rehydration solution solutions (osmolarity 210-268 mOsm/l, sodium 50-75 mEq/l) stool output was also reduced by about 20% and the incidence of vomiting by about 30%. The 245 mOsm/l solution also appeared to be as safe and at least as effective as standard oral rehydration salts (ORS) for use in children with cholera.

Table 2. World Health Organisation (WHO) New formula oral rehydration salts

Note: ORS = oral rehydration salts

In developed countries with non-cholera diarrhoea, it is generally thought that 90mmol/L is a little high, as non-cholera gastroenteritis does not result in the same sodium losses that are seen in cholera. Many different oral rehydration solutions with varying sodium concentrations have been developed. It has been shown ⁴ that water absorption across the lumen of the human intestine is maximal using solutions with a sodium concentration of 60mmol/L (such as Gastrolyte) and this is the concentration recommended by the European Society of Paediatric Gastroenterology and Nutrition ⁵. However some children who are not particularly dehydrated will refuse to drink such an oral rehydration solution because of its salty taste. Oral rehydration solutions with slightly less sodium such as Hydralyte may be more palatable, particularly as this comes in an iceblock form. Oral rehydration solutions with similar compositions to Hydralyte are safe and effective. These hypo-osmolar solutions (such as Gastrolyte and Hydralyte) are more effective at promoting water absorption than isotonic or hypertonic solutions ⁶.

The composition of various oral rehydration solutions and other fluids is shown in Tables 3 and 4. Fruit juices and soft drinks are inappropriate because of the minimal sodium content and the excessive glucose content and hence excessive osmolality, which will worsen diarrhea. Although diluting juices and soft drinks reduces glucose concentration, the fluid has insufficient sodium to act as a rehydration fluid. Sports drinks have varying sodium and carbohydrate levels, and are considered inappropriate as rehydration solutions.

Table 3. Composition of Oral Rehydration Solutions

Table 4. Composition of Oral Fluids

How to make Oral Rehydration Solution at home

To prevent too much liquid being lost from the child’s body, an effective oral rehydration solution can be made using ingredients found in almost every household. One of these drinks should be given to the child every time a watery stool is passed.

Here’s how you can make your own One (1) Liter Oral Rehydration Solution [ORS] using Salt, Sugar and Water at Home

Mix an oral rehydration solution using one of the following recipes:

Ingredients:

• Half (1/2) level teaspoon of Salt
• Six (6) level teaspoons of Sugar
• One (1) Litre of clean drinking or boiled water and then cooled

Make 5 cupfuls (each cup about 200 ml.)

Preparation Method:

• Stir the mixture till the salt and sugar dissolve.

The following traditional remedies make highly effective oral rehydration solutions and are suitable drinks to prevent a child from losing too much liquid during diarrhoea:

• Breastmilk
• Gruels (diluted mixtures of cooked cereals and water)
• Carrot Soup
• Rice water – Congee

A very suitable and effective simple solution for rehydrating a child can also be made by using salt and sugar, if these ingredients are available.

If possible, add 1/2 cup orange juice or some mashed banana to improve the taste and provide some potassium.

Molasses and other forms of raw sugar can be used instead of white sugar, and these contain more potassium than white sugar.

If none of these drinks is available, other alternatives are:

• Fresh fruit juice
• Weak tea
• Green coconut water

If nothing else is available, give water from the cleanest possible source – (if possible brought to the boil and then cooled).

Method of giving oral fluids

It is important to give small amounts of fluid frequently, for example 0.5mL per kg body weight every five minutes ². The fluid can be measured in a syringe and given to the child either by syringe, teaspoon or cup. The child is far more likely to tolerate these small amounts of fluid than if he/she drinks a large amount at once. Obviously if the child tolerates this fluid the parent can gradually increase the volume and decrease the frequency of the fluid offered.

Example of how much fluid to give to your child by age and body weight (approximates only):

• For infants less than 6 months old – See your doctor.
• For 6-23 months give 40 to 60 mL each hour.
• For 2-5 years give 60 to 100 mL each hour.
• For 6-10 years give 100 to 120 mL each hour.
• For 11-16 years give 120 to 160 mL each hour.
• For a 6 kg infant offer: 30mL every hour or 60mL every 2 hours.
• For a 12 kg toddler offer; 60mL every hour or 120mL every 2 hours.

IF YOU HAVE ANY CONCERNS ABOUT YOUR CHILD’S PROGRESS, CONTACT YOUR DOCTOR OR LOCAL HOSPITAL IMMEDIATELY!

Consult your doctor or local hospital, as soon as possible, if you have any concerns about your child’s progress – especially if:

• your child is less than six months old
• your child has other health problems
• you are unable to get your child to take the right amount of fluids (see the table over the page)
• your child keeps vomiting
• your child is very tired or drowsy
• there is blood or mucus in your child’s poo
• there is green vomit
• your child has ongoing tummy pain
• your child has high fevers
• if your child has unexpected symptoms(eg: pain when passing urine, headache etc)
• or if your child does not seem to be getting better and/or you are worried for any other reason.

Medicines to stop vomiting are occasionally used for children with persistent vomiting and dehydration. Medicines to stop diarrhea are not recommended and are usually not helpful as they can cause other problems in children.

If your child tolerates the fluid, gradually increase the amount and decrease the frequency of the fluid offered. It is important to start offering easily digested foods as soon as the vomiting stops and no later than after 24 hours EVEN if the poos are still loose.

Children who are not dehydrated should continue to be fed an age appropriate diet. Children who require rehydration should recommence age appropriate diets as soon as vomiting settles. This should be within the first 12-24 hours. Formula fed infants should recommence full strength formula.

It is important to note that small, frequent amounts of fluid will hopefully minimize the vomiting, but will not reduce the diarrhea. The aim is for the fluid input to exceed the output by enough to rehydrate and then maintain hydration. Occasional vomiting alone should not be considered as failure of oral rehydration therapy.

What to do for a breastfed infant

• Continue breast feeding on demand or at least every 2 hours.
• In between breast feeds, water or oral rehydration solution may be offered.
• Do not give solids if your child is vomiting.

When the vomiting has stopped or after 24 hours:

• Continue 2nd-3rd hourly feeds or on demand.
• In between breast feeds, oral rehydration solution or water may be offered.
• If your baby is on solids introduce simple foods such as rice cereal, potato or pumpkin – even if the poos are still loose.

Parents can use the Parent Oral Rehydration Documentation Form below to record the fluid given and any vomits, diarrhea or urine passed.

Table 5. Parent Oral Rehydration Documentation Form

What to do for the bottle fed infant or older child

While your infant or child is still vomiting:

• Replace formula or usual drinks with oral rehydration fluid (from chemist) or suitable fluids.
• Aim to be back to usual strength formula/diet within 24 hours. If not, seek medical advice.
• Start usual formula or milk. Do not dilute.
• Continue giving feeds or drinks every 2-3 hours or more frequently if demanded.
• Offer age appropriate foods at meal times even if the poos are still loose.
• Occasionally children will develop lactose intolerance and the loose poos will continue. If that occurs, a doctor may advise that he/she will need lactose free milk for approximately 1 month.

Hydration tips for baby and children

Severe vomiting and diarrhea (runny poos) can quickly lead to dehydration in infants and young children. Seek medical attention promptly, if you are concerned. Frequent vomiting and runny poos means your child may be losing a lot of fluid from their body. Lost fluid must be replaced – initially with SUITABLE FLUIDS or BREAST MILK.

DO

• carry on breastfeeding or using formula, try to give small amounts more often than usual
• for babies on formula or solid foods – give them small sips of extra water
• give small children their usual diet
• give regular small sips of rehydration solution to replace lost fluids, salts and sugars – ask your pharmacist to recommend one

DON’T

• make baby formula weaker
• give young children fruit juice or fizzy drinks, it makes things like diarrhea or vomiting worse

Pedialyte for diarrhea

If you’re being sick or have diarrhea and are losing too much fluid you need to put back the sugar, salts and minerals that your body has lost.

Your pharmacist can recommend oral rehydration solution sachets like pedialyte. These are powders that you mix with water and then drink. Ask your pharmacist which ones are right for you or your child.

Oral Rehydration Solutions include Gastrolyte, Hydralyte, Pedialyte and Repalyte (available from chemist) are specially formulated to replace lost fluid. These should be mixed exactly to the manufacturer’s directions. It is very important to comply with the expiry dates of the rehydration solutions once they have been opened or made up. Oral rehydration solutions are specially designed to replace sugars and salts lost during an episode of gastroenteritis. It is better to give these over other clear fluids if it is available. Clear fluids such as juice, cordial or soft drink may be used with caution if an oral rehydration fluid is not available. However they must be diluted otherwise they may make the diarrhea worse.

Other suitable fluids include:

• Diluted cordial (one part cordial concentrate to 20 parts boiled then cooled water). For example, 5 mL (1 teaspoon) plus 100mL water.
• Diluted soft drink or juice (one part juice or soft drink to 5 parts boiled then cooled water). For example, 20 mL (1 tablespoon) plus 80mL water.

Ideally these drinks (preferably those that have been boiled) should contain:

• starches and/or sugars as a source of glucose and energy,
• some sodium and
• preferably some potassium.

What causes dehydration

Dehydration is when someone loses more fluids than they take in. When someone becomes dehydrated, it means the amount of water in their body has dropped below the level needed for normal body function. In hot weather it can be very easy for active children to become dehydrated. Some may even suffer heat exhaustion or even heat stroke. A child is more likely to be affected if they are involved in at least an hour of high intensity physical activity on a hot day. Some examples of high intensity activity include team sports (for example soccer, football or netball), swimming training, running or tennis.

Most children do not stop to drink as much as adults do. They may only stop to drink when they are very thirsty. By this time, children can already be mildly dehydrated.

People can get dehydrated:

• after strenuous exercise, especially in hot weather due to sweating
• after severe vomiting or diarrhea
• with a fever – a high temperature of 100.4 °F (38 °C) or more
• after drinking too much alcohol
• while taking certain medicines such as diuretics
• as a complication of diabetes
• if they don’t drink enough water
• been in the sun too long (heatstroke)

Anyone may become dehydrated, but babies, young children, older adults and people with long-term illnesses are at most risk.

You are dehydrated if your body doesn’t have enough water to keep it working properly. It can happen when your body loses too much fluid, such as from excessive sweating, vomiting or diarrhea.

Dehydration signs and symptoms

If you have mild to moderate dehydration, you might:

• be thirsty
• have a dry mouth, lips, tongue and eyes
• have a headache
• have nausea
• have dark urine, and not so much of it
• feeling dizzy or light-headed, particularly when standing up
• peeing little and less than 4 times a day

If you have severe dehydration, you might:

• be extremely thirsty
• have a very dry mouth
• eyes are dark and sunken
• be breathing fast
• have a fast heart rate and a low blood pressure
• have a fever
• have little or no urine
• be irritable, drowsy or confused

Babies who are severely dehydrated have a sunken fontanel, the soft spot on top of a baby’s head.

Severe dehydration is a serious problem, especially in babies and young children.

How you can reduce the risk of dehydration

Drink fluids when you feel any dehydration symptoms. Keep taking small sips and gradually drink more if you can.

You can use a spoon to make it easier for your child to swallow the fluids.

You should drink enough during the day so that your pee is a pale clear color.

Drink when there is a higher risk of dehydrating. For example, if you’re vomiting, sweating or you have diarrhoea.

Carers: making sure someone drinks enough

Sometimes people you care for don’t have a sense of how much they’re drinking.

To help them:

• make sure they drink during meal times
• make drinking a social thing like “having a cup of tea”
• offer them food with a high water content – for example, soups, ice cream, jellies or fruits like melon

Children need to stay hydrated

Two thirds of our bodies are made up of water. Being dehydrated can cause poor sports performance, tiredness, headaches and crankiness – and it can lead to serious medical problems.

Signs your child could be dehydrated include:

• dizziness or light-headedness
• nausea
• a headache
• dark yellow or brown urine
• dry lips, tongue, mouth or throat.

What is the best drink to have?

• Water should always be the first choice. Children should be encouraged to keep a water bottle with them at all times and to stop and drink during activity.
• Drinks that contain some carbohydrate (sugar) and extra salts (such as sports drinks) can be useful, but are not always needed.
• Children who are involved in high intensity activity for over an hour, 2-3 times a week may benefit from using sports drinks.
• Have chilled water and sports drink with you on a hot day when children are involved in high intensity exercise. This will help to keep them hydrated and happy
• Sports drinks may be useful during exercise but are not a good choice for general drinking. They are high in sugar and can promote excess energy intake. Water is the best choice!
• Be careful when choosing sports drinks. Some “energy” type drinks may contain other additives such as caffeine. These are not suitable for children.

How much to drink?

• It is hard to work out how much fluid an active child needs on any one day. This is because different amounts of fluid are needed based on the weather and the intensity of the exercise. As a guide:
• A younger child (under 10 years) will need about 200mls of fluid at the start of exercise and at least 100mls for every 20 minutes they are involved in physical activity. This is equal to about a 300ml bottle of water or sports drink every hour.
• Older children (10 years and above) will need double this amount. They will need about 400mls of fluid at the start of exercise and at least 200mls for every 20 minutes they are involved in physical activity. This is equal to about a 600ml bottle of water or sports drink every hour.

Dehydration treatment

If your child is dehydrated, give them more fluid to drink. Water is best. This is especially important during hot weather and when they are exercising. Encourage your child to drink before, during and after exercise.

If they are sick, try to have them drink 1 cup (250ml) of water per hour for 4 hours. If they are vomiting or have diarrhea, try specially prepared children’s rehydration drinks like pedialyte, which you can buy from your local pharmacy.

Babies and young children are more at risk of severe dehydration, which is a medical emergency.

Pedialyte ingredients

Pedialyte Classic Ingredients

Water, Dextrose. Less than 2% of: Citric Acid, Natural & Artificial Flavor, Potassium Citrate, Salt, Sodium Citrate, Sucralose, Acesulfame Potassium, Zinc Gluconate, and Yellow 6.

Pedialyte AdvancedCare Ingredients

Contains milk ingredients.

Water, Dextrose. Less than 1.0% of: Galactooligosaccharides, Citric Acid, Potassium Citrate, Salt, Sodium Citrate, Natural & Artificial Flavor, Sucralose, Acesulfame Potassium, Zinc Gluconate, Red 40, and Blue 1.

Pedialyte AdvancedCare Plus Ingredients

Contains milk ingredients.

Water, Dextrose. Less than 1% of: Galactooligosaccharides, Salt, Citric Acid, Potassium Citrate, Natural & Artificial Flavor, Sodium Citrate, Sucralose, Acesulfame Potassium, Zinc Gluconate, and Blue 1.

Pedialyte Powder Packs Ingredients (Grape)

Anhydrous Dextrose, Citric Acid, Potassium Citrate, Salt, Sodium Citrate. Less than 2% of: Natural & Artificial Flavor, Beet Powder Color, Calcium Silicate, Acesulfame Potassium, Sucralose, and Blue 1.

Pedialyte AdvancedCare Plus Powder Packs Ingredients

Anhydrous Dextrose, Short-Chain Fructooligosaccharides, Citric Acid, Salt, Potassium Citrate, Sodium Citrate, Natural & Artificial Flavor. Less than 2% of: Calcium Silicate, Acesulfame Potassium, Sucralose, and Blue 1.

Pedialyte Freezer Pops Variety Pack Ingredients

Grape (Water, Anhydrous Dextrose; Less than 2% of: Citric Acid, Salt, Sodium Carboxymethylcellulose, Potassium Citrate, Potassium Sorbate, Sodium Benzoate, Natural & Artificial Flavor, Sucralose, Acesulfame Potassium, Red 40, Blue 1), Blue Raspberry (Water, Anhydrous Dextrose; Less than 2% of: Citric Acid, Salt, Sodium Carboxymethylcellulose, Potassium Citrate, Potassium Sorbate, Sodium Benzoate, Natural & Artificial Flavor, Sucralose, Acesulfame Potassium, Blue 1), Cherry (Water, Anhydrous Dextrose; Less than 2% of: Citric Acid, Salt, Sodium Carboxymethylcellulose, Potassium Citrate, Potassium Sorbate, Sodium Benzoate, Natural & Artificial Flavor, Sucralose, Acesulfame Potassium, Red 40), and Orange (Water, Anhydrous Dextrose; Less than 2% of: Citric Acid, Salt, Sodium Carboxymethylcellulose, Potassium Citrate, Potassium Sorbate, Sodium Benzoate, Natural & Artificial Flavor, Sucralose, Acesulfame Potassium, Yellow 6, Red 40).

Pedialyte nutrition facts

Pedialyte Classic Mixed Fruit

Serving size: 12 fl oz (360 mL)

Amount Per Serving % DV. The % Daily Value (DV) tells you how much a nutrient in a serving of food contributes to a daily diet. 2,000 calories a day is used for general nutrition advice.

Nutrition Information

• Calories: 35
• Total Fat: 0 g (0% DV)
• Sodium: 370 mg (16% DV)
• Total Carbohydrate: 9 g (3% DV)
• Total Sugars: 9 g
• Added Sugars: 9 g (18% DV)
• Protein: 0g (0% DV)

Minerals

• Sodium: 370 mg (16% DV)
• Potassium: 280 mg (6% DV)
• Zinc: 2.8 mg (25% DV)
• Chloride: 440 mg (20% DV)

Pedialyte Classic Ingredients

Water, Dextrose. Less than 2% of: Citric Acid, Natural & Artificial Flavor, Potassium Citrate, Salt, Sodium Citrate, Sucralose, Acesulfame Potassium, Zinc Gluconate, and Yellow 6.

Use under medical supervision

• For infants under 1 year of age: Consult your doctor.
• For children 1 year and older and adults: Begin with small frequent sips every 15 minutes, increasing serving size as tolerated. Continue for as long as diarrhea is present.
• To maintain proper hydration, 1-2 liters (32 to 64 fl oz) of Pedialyte may be needed per day. Consult your doctor if vomiting, fever, or diarrhea continues beyond 24 hours or if consumption needs are greater than 2 liters (64 fl oz) per day.

Directions of use

• Tastes best when served cold.
• Do not use if printed band around cap or inner foil seal is missing or broken.
• Remove protective band and twist off cap.
• Remove and throw away protective foil seal.
• Do not add water or dilute.
• After opening, replace cap, refrigerate and use within 48 hours.
• Store unopened bottles in a cool place. Avoid excessive heat.
• Do not reuse bottle.

Pedialyte AdvancedCare Strawberry Lemonade

Serving size: 12 fl oz (360 mL)

Amount Per Serving % DV. The % Daily Value (DV) tells you how much a nutrient in a serving of food contributes to a daily diet. 2,000 calories a day is used for general nutrition advice.

Nutrition Information

• Calories: 25
• Total Fat: 0 g (0% DV)
• Sodium: 370 mg (16% DV)
• Total Carbohydrate: 6 g (2% DV)
• Total Sugars: 6 g
• Added Sugars: 6 g (12% DV)
• Protein: 0g (0% DV)

Minerals

• Sodium: 370 mg (16% DV)
• Potassium: 280 mg (6% DV)
• Zinc: 2.8 mg (25% DV)
• Chloride: 440 mg (20% DV)

Pedialyte AdvancedCare Ingredients

Contains milk ingredients.

Water, Dextrose. Less than 1.0% of: Galactooligosaccharides, Citric Acid, Potassium Citrate, Salt, Sodium Citrate, Natural & Artificial Flavor, Sucralose, Acesulfame Potassium, Zinc Gluconate, Red 40, and Blue 1.

Use under medical supervision

• For infants under 1 year of age: Consult your doctor.
• For children 1 year and older and adults: Begin with small frequent sips every 15 minutes, increasing serving size as tolerated. Continue for as long as diarrhea is present.
• To maintain proper hydration, 1-2 liters (32 to 64 fl oz) of Pedialyte AdvancedCare may be needed per day. Consult your doctor if vomiting, fever, or diarrhea continues beyond 24 hours or if consumption needs are greater than 2 liters (64 fl oz) per day.

Directions of use

• Do not use if printed band around cap or inner foil seal is missing or broken.
• Remove protective band and twist off cap.
• Remove and throw away protective foil seal.
• After opening, replace cap, refrigerate and use within 48 hours.
• Store unopened bottles in a cool place. Avoid excessive heat.
• Do not reuse bottle.

Pedialyte AdvancedCare Plus Berry Frost

Serving size: 12 fl oz (360 mL)

Amount Per Serving % DV. The % Daily Value (DV) tells you how much a nutrient in a serving of food contributes to a daily diet. 2,000 calories a day is used for general nutrition advice.

Nutrition Information

• Calories: 25
• Total Fat: 0 g (0% DV)
• Sodium: 490 mg (21% DV)
• Total Carbohydrate: 6 g (2% DV)
• Total Sugars: 6 g
• Added Sugars: 6 g (12% DV)
• Protein: 0g (0% DV)

Minerals

• Sodium: 490 mg (21% DV)
• Potassium: 280 mg (6% DV)
• Zinc: 2.8 mg (25% DV)
• Chloride: 630 mg (25% DV)

Pedialyte AdvancedCare Plus Ingredients

Contains milk ingredients.

Water, Dextrose. Less than 1% of: Galactooligosaccharides, Salt, Citric Acid, Potassium Citrate, Natural & Artificial Flavor, Sodium Citrate, Sucralose, Acesulfame Potassium, Zinc Gluconate, and Blue 1.

Use under medical supervision

• For infants under 1 year of age: Consult your doctor.
• For children 1 year and older and adults: Begin with small frequent sips every 15 minutes, increasing serving size as tolerated. Continue for as long as diarrhea is present.
• To maintain proper hydration, 1-2 liters (32 to 64 fl oz) of Pedialyte may be needed per day. Consult your doctor if vomiting, fever, or diarrhea continues beyond 24 hours or if consumption needs are greater than 2 liters (64 fl oz) per day.

Directions of use

• Tastes best when served cold.
• Do not use if printed band around cap or inner foil seal is missing or broken.
• Remove protective band and twist off cap.
• Remove and throw away protective foil seal.
• Do not add water or dilute.
• After opening, replace cap, refrigerate and use within 48 hours.
• Store unopened bottles in a cool place. Avoid excessive heat.
• Do not reuse bottle.

Pedialyte Powder Packs Grape

Serving size: 9 g (1/2 packet) prepared with 1 cup [237 mL] water. For ages 4+

Amount Per Serving % DV (Daily Value). The % Daily Value (DV) tells you how much a nutrient in a serving of food contributes to a daily diet. 2,000 calories a day is used for general nutrition advice.

Nutrition Information

• Calories: 25
• Total Fat: 0 g (0% DV)
• Sodium: 240 mg (10% DV)
• Potassium: 180 mg (5% DV)
• Total Carbohydrate: 6 g (2% DV)
• Total Sugars: 6 g
• Protein: 0g (0% DV)

Minerals

• Sodium: 10.6 mEq
• Potassium: 4.7 mEq
• Chloride: 294 mg
• Chloride: 8.3 mEq (8% DV)

Pedialyte Powder Packs Ingredients (Grape)

Anhydrous Dextrose, Citric Acid, Potassium Citrate, Salt, Sodium Citrate. Less than 2% of: Natural & Artificial Flavor, Beet Powder Color, Calcium Silicate, Acesulfame Potassium, Sucralose, and Blue 1.

Use under medical supervision

• Pedialyte Powder Packs and Freezer Pops are NOT for use for children under 1 year of age.
• For children 1 year and older and adults: Begin with small frequent sips every 15 minutes, increasing serving size as tolerated. Continue for as long as diarrhea is present.
• To maintain proper hydration, 4 – 8 servings (32 to 64 fl oz) of Pedialyte may be needed per day. Consult your doctor if vomiting, fever, or diarrhea continues beyond 24 hours or if consumption needs are greater than 2 liters (64 fl oz) per day.

Directions of use

• Tastes best served cold.
• Reconstitute only with water.
• Mix one pack of Pedialyte Powder with 16 fl oz (2 cups) water. Stir to dissolve.
• Store unused, reconstituted product in sealed container in refrigerator for up to 24 hours.
• Do not store powder packs at extreme temperatures.

Pedialyte AdvancedCare Plus Powder Packs (Strawberry Freeze)

Serving size: 17 g (1 Packet)

Amount Per Serving % DV (Daily Value). The % Daily Value (DV) tells you how much a nutrient in a serving of food contributes to a daily diet. 2,000 calories a day is used for general nutrition advice.

Nutrition Information

• Calories: 30
• Total Fat: 0 g (0% DV)
• Sodium: 650 mg (28% DV)
• Potassium: 370 mg (8% DV)
• Total Carbohydrate: 8 g (3% DV)
• Total Sugars: 8 g
• Added Sugars: 8 g (16% DV)
• Protein: 0g (0% DV)

Minerals

• Sodium: 650 mg (28% DV)
• Potassium: 370 mg (8% DV)
• Chloride: 840 mg (35% DV)

Pedialyte AdvancedCare Plus Powder Packs Ingredients

Anhydrous Dextrose, Short-Chain Fructooligosaccharides, Citric Acid, Salt, Potassium Citrate, Sodium Citrate, Natural & Artificial Flavor. Less than 2% of: Calcium Silicate, Acesulfame Potassium, Sucralose, and Blue 1.

Use under medical supervision

• For infants under 1 year of age: Consult your doctor.
• For children 1 year and older and adults: Begin with small frequent sips every 15 minutes, increasing serving size as tolerated. Continue for as long as diarrhea is present.
• To maintain proper hydration, 1-2 liters (32 to 64 fl oz) of Pedialyte may be needed per day. Consult your doctor if vomiting, fever, or diarrhea continues beyond 24 hours or if consumption needs are greater than 2 liters (64 fl oz) per day.

Directions of use

• Tastes best when served cold.
• Do not use if printed band around cap or inner foil seal is missing or broken.
• Remove protective band and twist off cap.
• Remove and throw away protective foil seal.
• Do not add water or dilute.
• After opening, replace cap, refrigerate and use within 48 hours.
• Store unopened bottles in a cool place. Avoid excessive heat.
• Do not reuse bottle.

Pedialyte Freezer Pops Variety Pack

• Grape, Blue Raspberry, Cherry, and Orange

Serving size: 63 mL (1 pop). Children over 4 and adults

Amount Per Serving % DV (Daily Value). The % Daily Value (DV) tells you how much a nutrient in a serving of food contributes to a daily diet. 2,000 calories a day is used for general nutrition advice.

Nutrition Information

• Calories: 5
• Total Fat: 0 g (0% DV)
• Sodium: 65 mg (3% DV)
• Potassium: 50 mg (1% DV)
• Total Carbohydrate: 2 g (1% DV)
• Total Sugars: 2 g
• Protein: 0g (0% DV)

Minerals

• Chloride: 2.2 mEq (2% DV)

Pedialyte Freezer Pops Variety Pack Ingredients

Grape (Water, Anhydrous Dextrose; Less than 2% of: Citric Acid, Salt, Sodium Carboxymethylcellulose, Potassium Citrate, Potassium Sorbate, Sodium Benzoate, Natural & Artificial Flavor, Sucralose, Acesulfame Potassium, Red 40, Blue 1), Blue Raspberry (Water, Anhydrous Dextrose; Less than 2% of: Citric Acid, Salt, Sodium Carboxymethylcellulose, Potassium Citrate, Potassium Sorbate, Sodium Benzoate, Natural & Artificial Flavor, Sucralose, Acesulfame Potassium, Blue 1), Cherry (Water, Anhydrous Dextrose; Less than 2% of: Citric Acid, Salt, Sodium Carboxymethylcellulose, Potassium Citrate, Potassium Sorbate, Sodium Benzoate, Natural & Artificial Flavor, Sucralose, Acesulfame Potassium, Red 40), and Orange (Water, Anhydrous Dextrose; Less than 2% of: Citric Acid, Salt, Sodium Carboxymethylcellulose, Potassium Citrate, Potassium Sorbate, Sodium Benzoate, Natural & Artificial Flavor, Sucralose, Acesulfame Potassium, Yellow 6, Red 40).

Use under medical supervision

• Pedialyte Powder Packs and Freezer Pops are NOT for use for children under 1 year of age.
• For children 1 year and older and adults: Offer Pedialyte Freezer Pops as frequently as desired.
• To maintain proper hydration, 16 to 32 Freezer Pops (or a total of 32 to 64 fl oz of any Pedialyte product) may be needed per day. Consult your doctor if vomiting, fever, or diarrhea continue beyond 24 hours or if consumption needs are greater than 32 Freezer Pops (64 fl oz) per day.
• Freezer Pops can be consumed without freezing, but the flavors are best when frozen.
• NOTE: Like colored ices, Pedialyte Freezer Pops may temporarily color mouth.

Directions of use

•  To eat frozen
  • Remove Pops from carton and freeze before separating.
  • Tear or cut carefully between sleeves along perforations.
  • Cut off top of sleeve.
• To drink
  • Cut carefully between sleeves along perforations.
  • Cut off top of sleeve and pour liquid into cup or glass and drink.
  • Discard unused portion of opened product.
  • Do not reuse plastic sleeves.
  • Store unopened pops in cool place. Avoid excessive heat.

Is pedialyte good for you

Pedialyte is a medical-grade rehydration solution. It is good for adding back fluid after fluid loss or to help prevent fluid and electrolyte problems during bouts of diarrhea or vomiting.

Can you drink pedialyte everyday

Pedialyte is a medical-grade rehydration solution that is meant to treat serious dehydration caused by vomiting or diarrhea and is not meant to be used everyday. Furthermore, Pedialyte drinks are usually high in kilojoules (energy) and added sugar and provide very few nutrients. They can also contribute to poor nutrition, tooth decay and weight gain.

It is really important to limit the number of sugary drinks that you and your children have and to encourage them to have healthier options like water. Drinking water is the best way to quench a thirst – and it doesn’t come with the sugar and the kilojoules.

Pedialyte vs Gatorade

Pedialyte is a medical-grade rehydration solution. It is good for adding back fluid after fluid loss or to help prevent fluid and electrolyte problems during bouts of diarrhea or vomiting.

Gatorade is a sports beverage like other sports beverages are designed to give athletes carbs, electrolytes, and fluid during high-intensity workouts that last an hour or more. For average people, they’re just another source of sugar and calories.

Sports drinks provide a simple and effective way to replace fluid and carbohydrate simultaneously during exercise. Of course, specialized products such as Gatorade are expensive and are best used in the right sporting situation. Some people use cordial or carbohydrate foods such as fruit, bars, confectionary or sandwiches to provide a fuel boost during exercise. A carbohydrate intake of about 50 g per hour is generally recommended for prolonged events. Successful strategies are ultimately decided by individual preferences and experience.

Water is a cheap and readily available fluid, and is often quoted to be the “best” drink for active people. However, carbohydrate intake is known to improve performance during events of longer than 90 minutes, by providing the muscles and brain with extra fuel. Recently a number of studies have shown that carbohydrate intake may also be of benefit for a workout of as little as one hour. It certainly won’t harm performance, although some individuals may need to count the cost or the kilojoules involved.

Examples of 50g carbohydrate snacks include:

• 750 mL sports drink or cordial
• 500 mL fruit juice or soft drink
• 250 mL og liquid meal supplement (eg. Sustagen)
• 250 mL fruit smoothie
• 3 medium pieces of fruit
• honey or jam sandwich
• 60g packet of jelly beans or jubes
• 1 carton of fruit yoghurt + 250 mL of fruit juice
• bowl cereal + skim milk
• carton of fromage frais + granola bar

Pedialyte side effects

There are no known drug interactions for Pedialyte (electrolyte replacement solutions). However, this does not necessarily mean no interactions exist. Always consult with your doctor or pharmacist.

Applies to electrolyte replacement solutions: oral packet, oral powder for solution, oral powder for suspension, oral solution, oral tablet

Along with its needed effects, electrolyte replacement solutions (the active ingredient contained in Pedialyte) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur while taking electrolyte replacement solutions:

Symptoms of too much sodium (hypernatremia) in the body

• Convulsions (seizures)
• dizziness
• fast heartbeat
• high blood pressure
• irritability
• muscle twitching
• restlessness
• swelling of feet or lower legs
• weakness

Symptoms of too much fluid in the body

• Puffy eyelids

Some side effects of electrolyte replacement solutions may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. 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:

More common

• Vomiting (mild)

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 fluid and electrolyte problems like mood changes, confusion, muscle pain or weakness, a heartbeat that does not feel normal, very bad dizziness or passing out, fast heartbeat, more thirst, seizures, feeling very tired or weak, not hungry, unable to pass urine or change in the amount of urine produced, dry mouth, dry eyes, or very bad upset stomach or throwing up.

1. What is Pedialyte? https://pedialyte.com/what-is-pedialyte
2. Infants and Children: Management of Acute Gastroenteritis, Fourth Edition 19-Dec-2014. http://www1.health.nsw.gov.au/pds/ActivePDSDocuments/GL2014_024.pdf
3. New formula oral rehydration salts. http://apps.who.int/medicinedocs/en/d/Js4950e/2.4.html
4. Aperia A. et al. Salt and water homeostasis during oral rehydration therapy. J Pediatr 1983;103:364-69
5. Booth I, Ferreira R, Desjeux JF et al. Recommendation for composition of oral rehydration solutions for the children of Europe. Report of an ESPGAN working group. J Pediatric Gastroenterology and Nutrition. 1992;14:113-115.
6. International Study Group on Reduced-osmolarity ORS solutions. Multicentre evaluation of reduced-osmolarity oral rehydration salts solution. Lancet. 1995;345:282-285.
7. Assessing the Palatability of Oral Rehydration Solutions in School-aged ChildrenA Randomized Crossover Trial. Arch Pediatr Adolesc Med. 2010;164(8):696-702. doi:10.1001/archpediatrics.2010.129 https://jamanetwork.com/journals/jamapediatrics/fullarticle/383602

What are antibiotics

Antibiotics are powerful medicines used to treat a wide variety of infections or diseases caused by bacteria, such as respiratory tract infections (e.g., pneumonia and whooping cough), urinary tract infections, skin infections and infected wounds or prevent some types of bacterial infection. Used properly, antibiotics can save lives. Antibiotics only work on bacteria, not other infections like viruses that cause colds, flu, most sore throats, most coughs and bronchitis and runny noses. Antibiotics damage bacteria so your body’s immune system can fight them. Antibiotics have revolutionized medicine and saved millions of lives following their introduction in the 1940s because they provided a means of treating many infectious diseases and bacterial infections, including serious infections like meningitis and bacterial sepsis or septicemia. Antibiotics work by killing bacteria or preventing them from reproducing and spreading. But they don’t work against viruses. For example, antibiotics don’t work for viral infections such as common colds and flu, and most coughs and sore throats. And many mild bacterial infections also get better on their own without using antibiotics. Taking an antibiotic when it’s not needed will not make a significant difference to how you feel or how fast you recover. When you start to feel better it’s usually because your immune system is doing the work to treat your infection

Taking antibiotics when you don’t need them can put you and your family at risk of a longer and more severe illness.

Antibiotics are used to treat or prevent some types of bacterial infections. They aren’t effective against viral infections, such as the common cold or flu.

Other common viral infections that don’t benefit from antibiotic treatment include:

• Cold
• Flu (influenza)
• Bronchitis
• Most coughs
• Some ear infections
• Some sinus infections
• Stomach flu

Taking an antibiotic for a viral infection:

• Won’t cure the infection
• Won’t keep other people from getting sick
• Won’t help you or your child feel better
• May cause unnecessary and harmful side effects
• Promotes antibiotic resistance

If you take an antibiotic when you actually have a viral infection, the antibiotic attacks bacteria in your body — bacteria that are either beneficial or at least not causing disease. This misdirected treatment can then promote antibiotic-resistant properties in harmless bacteria that can be shared with other bacteria, or create an opportunity for potentially harmful bacteria to replace the harmless ones.

Taking antibiotics when you have a virus may do more harm than good ¹:

• Taking antibiotics increases your risk of getting an antibiotic-resistant infection later.
• Antibiotics kill the healthy bacteria in the gut, allowing more harmful bacteria, such as C. difficile, to grow in its place.
• Although this infection is more commonly found in hospitals, it also occurs in clinics outside of the hospital. Read more about C. difficile.
• Antibiotics cause 1 out of 5 emergency department visits for adverse drug events.
• Antibiotics are the most common cause of emergency department visits for adverse drug events in children under 18 years of age.

It’s important to only take antibiotics for bacterial infections since they can put you or your child at risk for harmful side effects and antibiotic-resistant infections.

Antibiotics should only be prescribed to treat conditions:

• that aren’t especially serious but are unlikely to clear up without the use of antibiotics – such as moderately severe acne
• that aren’t especially serious but could spread to other people if not promptly treated – such as the skin infection impetigo or the sexually transmitted infection chlamydia
• where evidence suggests that antibiotics could significantly speed up recovery – such as a kidney infection
• that carry a risk of more serious complications – such as cellulitis or pneumonia

Table 1. Antibiotic Prescribing and Use in Doctor’s Offices

Different antibiotics work against different bacteria. Sometimes, doctors choose an antibiotic based on what they believe will work. At other times, doctors will perform tests (e.g. culture and sensitivity) to work out which bacteria are causing the infection, and which antibiotics are likely to be effective against them.

Many antibiotics are less effective than they once were due to bacteria becoming resistive to their effects. This is called antibiotic resistance which may be prevented by only using antibiotics if they are needed to treat a bacterial infection.

How does a physician decide which antibiotic to prescribe?

Physicians examine patients and consider their symptoms in order to tell if they should prescribe an antibiotic and, if so, which one. Physicians can also take a culture to see if bacteria are causing a particular illness, such as a throat culture to determine the presence of “strep throat.” For hospital infections and some community-acquired infections, the doctor will obtain an “antimicrobial susceptibility report” that indicates which families of antibiotic drugs are useful for the particular bacteria recovered from the infection. If the cause of the infection is unclear, but suspected to be due to bacteria, the doctor may prescribe a broad-spectrum antibiotic that is useful for controlling a wide variety of bacterial types. The physician may choose either a generic or trade-name (non-generic) antibiotic depending on the individual circumstances.

What are bacteria and viruses?

Many human infections are caused by either bacteria or viruses. Bacteria are tiny single-celled organisms, thought by some researchers to be related to plants. They are among the most successful life forms on the planet, and range in habitat from ice slopes to deserts.

Bacteria can be beneficial – for instance, gut bacteria help you to digest food – but some are responsible for a range of infections. These disease-causing varieties are called pathogenic bacteria. Many bacterial infections can be treated successfully with appropriate antibiotics, although antibiotic-resistant strains are beginning to emerge. Vaccination is available to prevent many important bacterial diseases.

A virus is an even smaller micro-organism that can only reproduce inside a host’s living cell. It is very difficult to kill a virus. That’s why some of the most serious communicable diseases known to medical science are viral in origin.

To cause disease, pathogenic bacteria must gain access into the body. The range of access routes for bacteria includes:

• Cuts
• Contaminated food or water
• Close contact with an infected person
• Contact with the faces of an infected person
• Breathing in the exhaled droplets when an infected person coughs or sneezes
• Indirectly, by touching contaminated surfaces – such as taps, toilet handles, toys and nappies.

Viruses are spread from one person to another by:

• Coughs
• Sneezes
• Vomits
• Bites from infected animals or insects
• Exposure to infected bodily fluids through activities such as sexual intercourse or sharing hypodermic needles.

Forgetting to wash your hands after handling pets and animals is another way for germs to be taken in by mouth.

Characteristics of the bacterium

Most bacteria, apart from the cocci variety, move around with the aid of small lashing tails (flagella) or by whipping their bodies from side to side. Under the right conditions, a bacterium reproduces by dividing in two. Each ‘daughter’ cell then divides in two and so on, so that a single bacterium can bloom into a population of some 500,000 or more within just eight hours.

If the environmental conditions don’t suit the bacteria, some varieties morph into a dormant state. They develop a tough outer coating and await the appropriate change of conditions. These hibernating bacteria are called spores. Spores are harder to kill than active bacteria because of their outer coating.

Bacteria types

Bacteria that cause disease are broadly classified according to their shape.

The four main groups include:

1. Bacilli – shaped like a rod with a length of around 0.03mm. Illnesses such as typhoid and cystitis are caused by bacilli strains.
2. Cocci – shaped like a sphere with a diameter of around 0.001mm. Depending on the sort, cocci bacteria group themselves in a range of ways, such as in pairs, long lines or tight clusters. Examples include Staphylococci (which cause a host of infections including boils) and Gonococci (which cause the sexually transmissible infection gonorrhea).
3. Spirochetes – as the name suggests, these bacteria are shaped like tiny spirals. Spirochetes bacteria are responsible for a range of diseases, including the sexually transmissible infection syphilis.
4. Vibrio – shaped like a comma. The tropical disease cholera, characterized by severe diarrhea and dehydration, is caused by the vibrio bacteria.

Curing a bacterial infection

The body reacts to disease-causing bacteria by increasing local blood flow (inflammation) and sending in cells from the immune system to attack and destroy the bacteria. Antibodies produced by the immune system attach to the bacteria and help in their destruction. They may also inactivate toxins produced by particular pathogens, for example tetanus and diphtheria.

Serious infections can be treated with antibiotics, which work by disrupting the bacterium’s metabolic processes, although antibiotic-resistant strains are starting to emerge. Immunization is available to prevent many important bacterial diseases such as Hemophilus influenza Type b (Hib), tetanus and whooping cough.

Virus types

A virus is a miniscule pocket of protein that contains genetic material. If you placed a virus next to a bacterium, the virus would be dwarfed. For example, the polio virus is around 50 times smaller than a Streptococci bacterium, which itself is only 0.003mm long. Viruses can be described as either RNA or DNA viruses, according to which type of nucleic acid forms their core.

The four main types of virus include:

1. Icosahedral – the outer shell (capsid) is made from 20 flat sides, which gives a spherical shape. Most viruses are icosahedral.
2. Helical – the capsid is shaped like a rod.
3. Enveloped – the capsid is encased in a baggy membrane, which can change shape but often appears spherical.
4. Complex – the genetic material is coated, but without a capsid.

The body’s response to viral infection

Viruses pose a considerable challenge to the body’s immune system because they hide inside cells. This makes it difficult for antibodies to reach them. Some special immune system cells, called T-lymphocytes, can recognize and kill cells containing viruses, since the surface of infected cells is changed when the virus begins to multiply. Many viruses, when released from infected cells, will be effectively knocked out by antibodies that have been produced in response to infection or previous immunization.

Curing a viral infection

Antibiotics are useless against viral infections. This is because viruses are so simple that they use their host cells to perform their activities for them. So antiviral drugs work differently to antibiotics, by interfering with the viral enzymes instead.

The treatment of viral infections can include:

• managing symptoms, such as honey for coughs and warm fluids like chicken soup for oral hydration
• paracetamol to relieve fever
• stopping viral reproduction using antiviral medicines, such as medicines for HIV/AIDS and cold sores
• preventing infection in the first place, such as vaccines for flu and hepatitis

Antiviral drugs are currently only effective against a few viral diseases, such as influenza, herpes, hepatitis B and C and HIV – but research is ongoing. A naturally occurring protein, called interferon (which the body produces to help fight viral infections), can now be produced in the laboratory and is used to treat hepatitis C infections.

Vaccination against viral infection is not always possible

It is possible to vaccinate against many serious viral infections such as measles, mumps, hepatitis A and hepatitis B. An aggressive worldwide vaccination campaign, headed by the World Health Organization (WHO), managed to wipe out smallpox. However, some viruses – such as those that cause the common cold – are capable of mutating from one person to the next. This is how an infection with essentially the same virus can keep dodging the immune system. Vaccination for these kinds of viruses is difficult, because the viruses have already changed their format by the time vaccines are developed.

Antibiotic resistance

Many bacterial infections are treated with antibiotics. Sometimes the bacteria change to protect themselves against the antibiotic. When this happens the antibiotic no longer works. This is called antibiotic resistance and is a serious global problem.

Bacteria become antibiotic resistant when their genes mutate after being in contact with an antibiotic. These changes allow the bacteria to survive or ‘resist’ the antibiotic, so that the antibiotic no longer works to kill the bacteria or stop them from multiplying.

As more antibiotics stop working against bacterial infections, doctors will have fewer antibiotics to use. Many common infections may eventually become untreatable with antibiotic medicines.

• The World Health Organization (WHO) has warned that antibiotic resistance is one of the greatest threats to global public health today.
• Approximately 2 million infections from antibiotic-resistant bacteria occur in the United States each year, resulting in 23,000 deaths.
• Other consequences of medication-resistant infections include:
  • More-serious illness
  • Longer recovery
  • More-frequent or longer hospitalization
  • More doctor visits
  • More-expensive treatments

In the last 50 years only one antibiotic that works in a new way has been discovered and developed for use in humans.

In 2015, media reported the discovery of a new class of antibiotics, called teixobactin, as a “breakthrough” and a “game-changer”. However the new antibiotic has not yet even been tested in people. So far it has only been shown to be toxic to bacteria in mice. It will likely be years before it becomes a viable option in humans.

This new antibiotic only works on certain types of bacteria (gram-positive)—so it would help for some of the currently hard-to-treat infections, but not all.

For example, it is not effective against E coli (as that is gram-negative) which can be resistant to antibiotics.

The time it is taking for bacteria to become resistant to new antibiotics is getting shorter, so even if new antibiotics are discovered, this will likely become an issue again if we don’t change the way we use antibiotics.

Antibiotic resistance is already affecting individuals in the community.

Infection with antibiotic-resistant bacteria is associated with longer stays in hospital and a higher death rate. In America like other developed countries, the prevalence of multi-resistant bacteria (also known as ‘superbugs’) is increasing, and more patients are getting staph infections that are resistant to multiple antibiotics.

If you have an infection that is caused by bacteria which is resistant to antibiotics you are more likely to die from that infection.

Examples of bacteria in the community that have already developed resistance to a number of antibiotics include strains of Escherichia coli (E coli) that cause many urinary tract infections. ‘Golden staph’, a common cause of skin infections, is another example.

Failure of the last-resort antibiotic treatment for the sexually transmitted infection gonorrhea has occurred in the US.

How do bacteria develop antibiotic resistance?

Bacteria can change their genes after being exposed to an antibiotic. This allows them to survive antibiotic treatment. Then, when they multiply, they make more resistant bacteria. This is how antibiotic resistance develops.

Furthermore, bacteria can also develop antibiotic resistance through contact with other bacteria. Resistant bacteria can pass their genes to other bacteria, forming a new antibiotic-resistant ‘strain’ of the bacteria.

The more antibiotics are used, the more chances bacteria have to become resistant to them.

Why is antibiotic resistance a problem?

Antibiotic resistance happens when bacteria survive and continue causing infection despite treatment with an antibiotic – the bacteria are no longer sensitive to that antibiotic.

What does antibiotic resistance mean for me?

Using antibiotics when you don’t need them may mean that they won’t work for you when you do need them in the future.

If you or a member of your family develop an antibiotic-resistant infection:

• you will have the infection for longer
• you may be more likely to have complications of the infection
• you could remain infectious for longer, and pass your infection to other people, which increases the problem.

You could be passing it on

You could be passing on antibiotic-resistant bacteria to other people:

• if you take antibiotics for cold and flu viruses
• if you don’t take antibiotics as prescribed
• if you neglect good hygiene.

Antibiotic resistance can have personal consequences for you, your family and the community

Antibiotic-resistant bacteria can persist in your body for as long as 12 months and may be passed on to family members or others in the community.

Because the antibiotic no longer works against the resistant bacteria:

• infections take longer to heal
• infections can get worse and lead to more serious problems
• infections are more likely to spread to other people and because bacteria are resistant, the antibiotic may not work for other people, further spreading the problem

You might think it best to use another antibiotic to which bacteria aren’t resistant. However, it may not work as well, and it could have side effects. Also, bacteria may eventually become resistant to this antibiotic too.

For these reasons, antibiotic resistance is a major threat to human health. There is concern that in time, there will be bacterial infections that just can’t be treated with all the currently available antibiotics.

What causes antibiotic resistance?

The more bacteria are exposed to antibiotics, the more chances they have to change and become resistant. When you use antibiotics when not needed or don’t take antibiotics properly – such as missing doses or not completing the course – you give bacteria opportunities to become resistant.

How can I help prevent antibiotic resistance?

Antibiotic resistance can’t be totally stopped, but it can be slowed down by sensibly using antibiotics. You can help by:

• not taking antibiotics for a cold or the flu, including cough and sore throat; viruses cause most colds, and antibiotics don’t work against viruses
• telling your doctor you only want antibiotics when necessary – such as for serious bacterial infections such as pneumonia
• taking your antibiotic as prescribed, and completing the full course
• never saving antibiotics for the next time you’re sick
• never taking antibiotics prescribed for someone else
• having good hygiene practices to avoid spreading infections

Sharing antibiotics and using leftovers can increase antibiotic resistance

When bacteria encounter an antibiotic, they adapt to protect themselves.

There are actions that you can take to reduce the chance of resistance developing.

• Take the prescribed dose and complete the whole course of treatment prescribed by your doctor. Even if you are feeling better, taking the whole course reduces the chance that some bacteria will survive and become resistant.
• Don’t share antibiotics with another person. This is important because the type of antibiotic may not be targeted to the bacteria causing their particular infection.
• Don’t keep leftovers. The dose and amount leftover may not be enough to destroy a new infection – creating more opportunity for resistant bacteria to develop and multiply.

What are ‘superbugs’?

‘Superbugs’ are bacteria that are difficult to treat because they are resistant to several different antibiotics, and especially antibiotics that treat other resistant bacteria.

Superbugs such as Methicillin-Resistant Staphylococcus aureus (MRSA), Clostridium difficile (also known as C. difficile or C. diff, is a bacterium that can infect the bowel and cause diarrhea often bloody diarrhea), the bacteria that cause tuberculosis (Mycobacterium tuberculosis) and multi-drug-resistant strains of Escherichia coli (E. coli) the bacteria that cause many urinary tract infections are becoming more common and are now very hard to treat because of antibiotic resistance and can be a real problem in hospitals.

These types of infections can be serious and challenging to treat, and are becoming an increasing cause of disability and death across the world.

The biggest worry is that new strains of bacteria may emerge that can’t be effectively treated by any existing antibiotics.

Do I need antibiotics for a common cold or the flu?

Good-quality, reliable clinical studies have shown that antibiotics do not improve the symptoms of a cold or the flu. This is because antibiotics work only on infections caused by bacteria – common colds and the flu are infections caused by viruses.

Antibiotics will not:

• help a cold or the flu get better faster
• stop a cold or the flu from getting worse or
• stop a cold or the flu from spreading to other people.

If you are usually healthy and well, your immune system will take care of most respiratory tract infections – both viral and some bacterial infections – by itself.

However, antibiotics are more likely to be needed for people who:

• have serious infections caused by bacteria (e.g., whooping cough)
• have an ongoing health condition (e.g., asthma, diabetes or lung disease)
• are older or in generally poor health, or have a weakened immune system (e.g., due to HIV infection)
• have a higher risk of complications with a respiratory tract infection (complications often include bacterial infections).

Using antibiotics when you don’t need them can contribute to the problem of antibiotic resistance. This might mean that if you have a serious infection, such as pneumonia, in the future, antibiotics may not work as well.

When are antibiotics used?

Antibiotics may be used to treat bacterial infections that:

• are unlikely to clear up without antibiotics
• could infect others unless treated
• could take too long to clear without treatment
• carry a risk of more serious complications

People at a high risk of infection may also be given antibiotics as a precaution, known as antibiotic prophylaxis.

People at risk of bacterial infections

Antibiotics may also be recommended for people who are more vulnerable to the harmful effects of infection. This may include:

• people aged over 75 years
• babies less than 72 hours old with a confirmed bacterial infection, or a higher than average risk of developing one
• people with heart failure
• people who have to take insulin to control their diabetes
• people with a weakened immune system – either because of an underlying health condition such as HIV infection or as a side effect of certain treatments, such as chemotherapy

Principles of antibiotic prescribing

Antibiotics are prescribed for three reasons ³:

1. Prophylaxis – where administration of antibiotic is designed to prevent serious infection in a defined at-risk situation
2. Empiric therapy – where a clinical syndrome that may be due to infection is managed before evidence confirming the presence of infection or its cause is available
3. Directed therapy – where antibiotics are aimed at micro-organisms which have been confirmed as the cause of an infection.

For each type of therapy, there are principles that aim to minimize the use of antibiotics and also ameliorate the selection of antibiotic resistance.

Antibiotic prophylaxis

Antibiotics are sometimes given as a precaution to prevent, rather than treat, an infection. This is known as antibiotic prophylaxis. Prophylactic antibiotic is normally recommended if you’re having surgery on a certain part of the body which carries a high risk of infection or where infection could lead to devastating effects. For example, antibiotic prophylaxis  is used for medical (for example, preventing relapses of rheumatic fever, infective endocarditis prevention for certain heart disease or the spread of meningococcal infection) and surgical purposes (prevention of wound infection).

For example, antibiotic prophylaxis may be used if you’re going to have:

• some types of eye surgery – such as cataract surgery or glaucoma surgery
• joint replacement surgery
• breast implant surgery
• pacemaker surgery
• surgery to remove the gall bladder
• surgery to remove the appendix

Your surgical team will be able to tell you if you require antibiotic prophylaxis.

Bites or wounds

Antibiotic prophylaxis may be recommended for a wound that has a high chance of becoming infected – this could be an animal or human bite, for example, or a wound that has come into contact with soil or feces.

Medical conditions

There are several medical conditions that make people particularly vulnerable to infection, making antibiotic prophylaxis necessary.

For example, the spleen plays an important role in filtering out harmful bacteria from the blood. People who have had their spleen removed, people having chemotherapy for cancer, or those with the blood disorder sickle cell anemia, where their spleen doesn’t work properly, should take antibiotics to prevent infection.

In some cases, antibiotic prophylaxis is prescribed for people who experience a recurring infection that’s causing distress or an increased risk of complications, such as:

• cellulitis
• a urinary tract infection
• genital herpes
• rheumatic fever

Recommendations to use antibiotic prophylaxis for a particular type of surgical operation are made after consideration of:

• the incidence of surgical wound infection
• the usual impact of this infection
• the demonstrated effectiveness of antibiotic prophylaxis in preventing these infections (randomized trial evidence).

Reducing bacterial resistance selection by antibiotic prophylaxis

Exposure to antibiotic surgical prophylaxis is often the initial selective pressure placed upon a patient’s bacterial flora on entry to hospital. The flora is modified in such a way as to facilitate colonization (and potential ensuing infection) with more resistant hospital bacteria. In order to minimize this adverse impact and to maximize effectiveness of antibiotic prophylaxis, narrow spectrum drugs should be used for the shortest time possible.

Empiric therapy

Patients often present with symptoms that may be caused by infection. A decision then has to be made about the likely cause of infection and whether it needs drug treatment. On occasions empiric antibiotic therapy is also used to prevent complications arising from a minor infection.

Are antibiotics indicated?

The decision to use antibiotics in a particular clinical situation is complex. It balances the natural history of the disease or syndrome, the potential seriousness of its outcomes, evidence that antibiotics affect these outcomes and the potential adverse effects of antibiotic therapy. Doctors now recognize that antibiotics are a precious resource, crucial to the management of many potentially fatal infections (such as meningitis). In order to actively safeguard future antibiotic effectiveness in these diseases doctors must reduce their reliance on antibiotics for mild or self-limiting conditions in hospitals and the community.

Hospital setting

Difficulties often arise in intensive care units (ICUs) where clinical features are frequently non-specific. For instance, although antibiotics are usually given for lung consolidation in severely ill patients, it is estimated that fewer than 50% of these patients actually have an infective cause for the consolidation ⁴.

Community setting

Most antibiotics are prescribed for patients with upper respiratory infection (acute otitis media, pharyngitis, sinusitis) and acute bronchitis. These conditions are most often caused by viruses and are of self-limited duration. Randomized trials show antibiotics have limited or no impact. The antibiotic guidelines published by Therapeutic Guidelines ³ place increasing emphasis on effective (non-antibiotic) symptom management, preventative measures such as immunization and where possible, evidence-based selection of subsets of patients that are most likely to benefit from antibiotic therapy. For example, in acute otitis media, children presenting with systemic symptoms such as high fever or vomiting are more likely, than children without these symptoms, to benefit from antibiotic therapy ⁵. The treatment of otitis media with antibiotics cannot be justified on the grounds of preventing mastoiditis as trial data show that this complication is rare in developed countries (1 per 1000 or less) ⁶.

Choice of antibiotic

If an antibiotic is indicated, a drug should be chosen that will limit the development of bacterial resistance (Table 2). The choice of drug is influenced by the likely pathogens and local resistance patterns.

Duration of empiric therapy

In hospital, the patient should be reassessed after 24–48 hours of empiric antibiotic therapy to decide whether infection is unlikely (cease therapy) or whether a firm diagnosis can be made (modify therapy as appropriate (see also Table 2). In community practice, as a general rule, the minimum duration of treatment recommended in Therapeutic Guidelines: Antibiotic ³ should be prescribed.

Table 2. Reducing bacterial resistance selection in empiric treatment with antibiotics

Directed therapy

When the cause of an infection is confirmed, antibiotic therapy is aimed at those micro-organisms. The confirmation may come from clinical or pathological information. Microbiological confirmation is preferred as it gives the greatest assurance that the correct antibiotic drug has been chosen. The involvement of a specific pathogen may be implied by evidence from microscopy, culture or direct detection through nucleic acid amplification (for example, polymerase chain reaction testing for meningococci in blood or cerebrospinal fluid).

Therapeutic Guidelines: Antibiotic ³ provides evidence-based recommendations for directed therapy for common infections. Correct selection of the antibiotic drug, its dosage and route are crucial to minimizing the emergence of resistance during therapy. For instance, the common practice of prescribing prolonged (more than 10 days) monotherapy with oral ciprofloxacin for Pseudomonas aeruginosa respiratory infection usually leads to stable high level ciprofloxacin resistance in this organism. Another common pitfall is the use of oral monotherapy with rifampicin, fusidic acid or ciprofloxacin for infections due to Methicillin-Resistant Staphylococcus aureus (MRSA), as resistance usually emerges during treatment. In both these circumstances, more resistant bacteria are created that frequently cause therapeutic difficulty in the patient or indeed another person who acquires the resistant strain from the treated patient.

Duration of treatment

Appropriate minimum durations of antibiotic therapy have only been investigated for a few infectious diseases. These include bacterial endocarditis, bone and joint disease and meningitis. Unfortunately, duration of therapy for some common sites of infection such as the lung is not well studied. In these situations, the decision to cease therapy is usually based on clinical criteria. Where possible, minimizing the duration of therapy is a key way to reduce emergence of resistance.

How do antibiotics work

Antibiotics work by blocking vital processes in bacteria, killing the bacteria or stopping them from multiplying. This helps the body’s natural immune system to fight the bacterial infection. Different antibiotics work against different types of bacteria.

• Antibiotics that affect a wide range of bacteria are called broad spectrum antibiotics (e.g., amoxicillin and gentamicin).
• Antibiotics that affect only a few types of bacteria are called narrow spectrum antibiotics (e.g., penicillin).

Different types of antibiotics work in different ways. For example, penicillin destroys bacterial cell walls, while other antibiotics can affect the way the bacterial cell works.

Doctors choose an antibiotic according to the bacteria that usually cause a particular infection. Sometimes your doctor will do a test to identify the exact type of bacteria causing your infection and its sensitivity to particular antibiotics.

Antibiotic medicines may contain one or more active ingredients and be available under different brand names. The active ingredient is the chemical in a medicine that makes it work. The medicine label should tell you the active ingredient and the brand name.

Types of antibiotics

There are hundreds of different types of antibiotics, but most of them can be broadly classified into six groups. These are outlined below.

1. Penicillins (such as penicillin and amoxicillin) – widely used to treat a variety of infections, including skin infections, chest infections and urinary tract infections
2. Cephalosporins (such as cephalexin) – used to treat a wide range of infections, but some are also effective for treating more serious infections, such as septicaemia and meningitis
3. Aminoglycosides (such as gentamicin and tobramycin) – tend to only be used in hospital to treat very serious illnesses such as septicaemia, as they can cause serious side effects, including hearing loss and kidney damage; they’re usually given by injection, but may be given as drops for some ear or eye infections
4. Tetracyclines (such as tetracycline and doxycycline) – can be used to treat a wide range of infections, but are commonly used to treat moderate to severe acne and rosacea
5. Macrolides (such as erythromycin and clarithromycin) – can be particularly useful for treating lung and chest infections, or an alternative for people with a penicillin allergy, or to treat penicillin-resistant strains of bacteria
6. Fluoroquinolones (such as ciprofloxacin and levofloxacin) – broad-spectrum antibiotics that can be used to treat a wide range of infections.

Amoxicillin antibiotic

Amoxicillin is an antibiotic that is commonly used to treat bacterial infections, such as chest infections (including pneumonia), dental abscesses and urinary tract infections (UTIs). Amoxicillin is a similar antibiotic to penicillin. It works by killing the bacteria that cause the infection.

Amoxicillin is used in children, often to treat ear infections and chest infections.

Amoxicillin antibiotic is only available on prescription. Amoxicillin comes as capsules or as a liquid that you drink. Amoxicillin is also given by injection, but this is usually only done in hospital.

• For most infections, you’ll start to feel better in a few days. Tell your doctor if you don’t start feeling better after taking amoxicillin for 3 days. Also tell them if, at any time, you start to feel worse.
• Carry on taking this medicine until you’ve completed the course, even if you feel better. If you stop your treatment early, the infection could come back.
• The most common side effects of amoxicillin are feeling sick and diarrhea.
• Liquid amoxicillin can stain your teeth. This doesn’t last and is removed by brushing.
• You can drink alcohol while taking amoxicillin.

Who can and can’t take amoxicillin

Amoxicillin can be taken by adults, including pregnant and breastfeeding women.

Amoxicillin can be taken by children.

Amoxicillin isn’t suitable for some people. To make sure amoxicillin is safe for you, tell your doctor if you:

• have had an allergic reaction to amoxicillin or penicillin or any other medicines in the past
• have liver or kidney problems
• have recently had, or are about to have, any vaccinations

How and when to take amoxicillin

The usual dose of amoxicillin is 250mg to 500mg taken 3 times a day. The dose may be lower for children.

Try to space the doses evenly throughout the day. If you take it 3 times a day, this could be first thing in the morning, mid-afternoon, and at bedtime.

You can take amoxicillin before or after food.

How to take amoxicillin

Swallow amoxicillin capsules whole with a drink of water. Don’t chew or break them.

Amoxicillin is available as a liquid for children and people who find it difficult to swallow tablets.

If you or your child are taking amoxicillin as a liquid, it will usually be made up for you by your pharmacist. The medicine will come with a plastic syringe or spoon to help you measure out the right dose. If you don’t have one, ask your pharmacist for one.

What if I forget to take it?

If you forget to take a dose, take it as soon as you remember, unless it’s nearly time for your next dose. In this case, just leave out the missed dose and take your next dose as normal.

Never take 2 doses at the same time. Never take an extra 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 remember your medicines.

What if I take too much?

Accidentally taking an extra dose of amoxicillin is unlikely to harm you or your child.

Speak to your pharmacist or doctor if you’re worried or you take more than 1 extra dose.

Amoxicillin side effects

Like all medicines, amoxicillin can cause side effects, although not everyone gets them.

Common side effects

These common side effects happen in around 1 in 10 people. Keep taking the medicine, but talk to your doctor or pharmacist if these side effects bother you or don’t go away:

• feeling sick
• diarrhea

How to cope with side effects

What to do about:

• feeling sick – stick to simple meals and don’t eat rich or spicy food. It might help to take your amoxicillin after a meal or snack.
• diarrhea – drink plenty of water or other fluids if you have diarrhea. It may also help to take oral rehydration solutions, which you can buy from a pharmacy, to prevent dehydration. Don’t take any other medicines to treat diarrhea without speaking to a pharmacist or doctor.

Serious side effects

Serious side effects are rare and happen in less than 1 in 1,000 people.

Tell a doctor straight away if you get:

• severe, bloody diarrhea
• yellowing of the whites of the eyes and skin [jaundice] (warning signs of liver or gallbladder problems)
• a bad skin rash that may include flushing, fever, blisters or ulcers, or skin that looks like it’s been burnt
• bruising or skin discoloration
• joint or muscle pain that comes on after 2 days of taking the medicine
• a skin rash with circular red patches
• dark pee

Some of these serious side effects can happen up to 2 months after finishing the amoxicillin.

Serious allergic reaction

Around 1 in 15 people have an allergic reaction to amoxicillin.

• 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.

In most cases, the allergic reaction is mild and can take the form of:

• a raised, itchy skin rash
• coughing
• wheezing

Mild allergic reactions can usually be successfully treated by taking antihistamines.

In rare cases, amoxicillin can 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 amoxicillin. For a full list see the leaflet inside your medicines packet.

Cautions with other medicines

There are some medicines that don’t mix well with amoxicillin.

Tell your doctor if you’re taking these medicines before you start taking amoxicillin:

• methotrexate
• a blood thinner called warfarin
• gout medicines called probenecid and allopurinol
• other antibiotics

Mixing amoxicillin with herbal remedies and supplements

There are no known problems with taking herbal remedies and supplements alongside amoxicillin.

Will amoxicillin affect my contraception?

Amoxicillin doesn’t stop contraceptive pills working.

However, if amoxicillin makes you vomit or have severe diarrhea (6 to 8 watery poos in 24 hours) for more than 24 hours, your contraceptive pills may not protect you from pregnancy. Look on the pill packet to find out what to do.

Will amoxicillin affect my fertility?

Amoxicillin won’t affect your fertility. However, speak to a pharmacist or your doctor before taking it if you’re trying to get pregnant.

Will amoxicillin give me thrush?

Some people get a fungal infection called thrush after taking a course of antibiotics like amoxicillin. It happens because antibiotics kill the normal harmless bacteria that help to protect you against thrush.

Ask your doctor or pharmacist for advice if this happens to you.

Does amoxicillin stain teeth?

If you or your child take amoxicillin as a liquid medicine, it can stain your teeth. This doesn’t last and should go after brushing your teeth well.

Amoxicillin capsules don’t stain teeth.

Is there any food or drink I need to avoid?

You can eat and drink normally while taking amoxicillin.

Can I drive or ride a bike while taking amoxicillin?

Yes, amoxicillin shouldn’t affect you being able to drive or cycle.

Sulfonamide antibiotics

Sulfonamide antibiotics available on prescription in America include:

• Sulfamethoxazole used in combination with trimethoprim, available as Bactrim, Resprim or Septrin.
• Less commonly used sulfonamide antibiotics include sulfadiazine (tablets, injection or cream), sulfadoxine (for malaria), and sulfacetamide antibiotic eye drops.
• Sulfasalazine (Salazopyrin, Pyralin), used in inflammatory bowel disease or arthritis, is a combination sulfapyridine (a sulfonamide antibiotic) and a salicylate.

If you have had an allergic reaction to Bactrim, Resprim or Septrin, there is no way of knowing whether the allergy was to sulfamethoxazole or to trimethoprim, therefore you should avoid trimethoprim (Alprim, Triprim) as well as sulfonamide antibiotics.

Sometimes those who have had an allergic reaction to a sulfonamide antibiotic are labelled as “sulfur allergic” or allergic to sulfur, sulphur or sulfa. This wording should not be used since it is ambiguous and can cause confusion. Some people wrongly assume that they will be allergic to non-antibiotic sulfonamides or to other sulfur containing medicines or sulfite preservatives.

It is important to know that sulfur is an element which occurs throughout our body as a building block of life, and it is not possible to be allergic to sulfur itself.

Allergic reactions to sulfonamide antibiotics do not increase the likelihood of allergy to sulfur powder, sulfite preservatives, sulfates (in medicines, or soaps and shampoos) or non-antibiotic sulfonamide medicines like some pain killers or fluid tablets or other things that are yellow.

Other types of sulfur containing substances

Elemental sulfur powder

• This is commonly used in gardening, and while irritation may occur from skin contact or inhalation, allergy has not been described.

Sulfates

• Some injectable drugs are sulfate compounds, for example heparin sulfate, dextran sulfate, morphine sulfate. The sulfates in soaps (such as sodium lauryl sulfate) are strong detergents and can irritate the skin or eyes, however sulfate itself does not cause allergic reactions. It is usually safe to use a sulfate when a person has a sulfonamide allergy or a sulfite intolerance.

Sulfite preservatives

• Commonly known as sulfur dioxide and metabisulfites, preservative numbers 220-228, sulfites are a group of compounds used to preserve flavor and color within food, inhibit bacterial growth, reduce spoilage, stop fresh food from spotting and turning brown and help preserve medication and increase shelf life. Sulfites are found most often found in wine, dried fruit, dried vegetables and sometimes sausages and salads. They can also occur naturally in low concentrations. Sulfites can cause adverse reactions which are similar to allergy but do not involve the immune system and are therefore called intolerance. The most common reactions are asthma symptoms (in those with underlying asthma) and rhinitis (hay fever-like) reactions. Occasionally urticaria (hives) may occur, and very rarely, anaphylaxis (allergic shock). There is no relationship between sulfite sensitivity and sulfonamide antibiotic allergy.

Non-antibiotic sulfonamide medicines

• Other medications such as some fluid medicines, diabetes medicines and arthritis medicines contain sulfonamide components but these are not sufficiently similar to sulfonamide antibiotics to pose an allergy risk. These medicines do not need to be avoided by people who are allergic to sulfonamide antibiotics because the allergy rarely if ever cross-reacts.

Those who have had an allergic reaction to one sulfonamide antibiotic are usually advised to avoid all sulfonamide antibiotics. Since these antibiotics are not normally used in an emergency, wearing a MedicAlert bracelet is not routinely recommended although it may be advisable in those who have had life-threatening allergic reactions. Allergy is not always lifelong and cross-reaction does not always occur, therefore challenge with the same or a different sulfonamide antibiotic may be attempted (with caution, under specialist supervision) in those who have a strong indication for a sulfonamide antibiotic, if the allergic reaction was mild/moderate and in the distant past. Desensitisation, to switch off antibiotic allergy temporarily, is available should a sulfonamide antibiotic be the only suitable drug to use, but this is not always possible.

MRSA antibiotics

Evidence-based guidelines for the management of patients with methicillin-resistant Staphylococcus aureus (MRSA) infections were prepared by an Expert Panel of the Infectious Diseases Society of America (IDSA) ⁷. The guidelines are intended for use by health care providers who care for adult and pediatric patients with MRSA infections ⁸.

Management of skin and soft-tissue infections

For a cutaneous abscess, incision and drainage is the primary treatment. For simple abscesses or boils, incision and drainage alone is likely to be adequate, but additional data are needed to further define the role of antibiotics, if any, in this setting.

Antibiotic therapy is recommended for abscesses associated with the following conditions: severe or extensive disease (e.g., involving multiple sites of infection) or rapid progression in presence of associated cellulitis, signs and symptoms of systemic illness, associated comorbidities or immunosuppression, extremes of age, abscess in an area difficult to drain (e.g., face, hand, and genitalia), associated septic phlebitis, and lack of response to incision and drainage alone.

For outpatients with purulent cellulitis (e.g., cellulitis associated with purulent drainage or exudate in the absence of a drainable abscess), empirical therapy for community-associated-MRSA is recommended pending culture results. Empirical therapy for infection due to β-hemolytic streptococci is likely to be unnecessary. Five to 10 days of therapy is recommended but should be individualized on the basis of the patient’s clinical response.

For outpatients with nonpurulent cellulitis (eg, cellulitis with no purulent drainage or exudate and no associated abscess), empirical therapy for infection due to β-hemolytic streptococci is recommended. The role of community-associated-MRSA is unknown. Empirical coverage for community-associated-MRSA is recommended in patients who do not respond to β-lactam therapy and may be considered in those with systemic toxicity. Five to 10 days of therapy is recommended but should be individualized on the basis of the patient’s clinical response.

For empirical coverage of community-associated-MRSA in outpatients with skin and soft-tissue infection, oral antibiotic options include the following:

• clindamycin,
• trimethoprim-sulfamethoxazole (bactrim),
• a tetracycline (doxycycline or minocycline) and linezolid.

If coverage for both β-hemolytic streptococci and community-associated-MRSA is desired, options include the following: clindamycin alone or trimethoprim-sulfamethoxazole (bactrim) or a tetracycline in combination with a β-lactam (e.g., amoxicillin) or linezolid alone.

The use of rifampin as a single agent or as adjunctive therapy for the treatment of skin and soft-tissue infection is not recommended.

For hospitalized patients with complicated skin and soft-tissue infection (defined as patients with deeper soft-tissue infections, surgical/traumatic wound infection, major abscesses, cellulitis, and infected ulcers and burns), in addition to surgical debridement and broad-spectrum antibiotics, empirical therapy for MRSA should be considered pending culture data. Options include the following:

• intravenous (IV) vancomycin (A-I), oral (PO) or IV linezolid 600 mg twice daily,
• daptomycin 4 mg/kg/dose IV once daily,
• telavancin 10 mg/kg/dose IV once daily and clindamycin 600 mg IV or PO 3 times a day.
• A β-lactam antibiotic (e.g., cefazolin) may be considered in hospitalized patients with nonpurulent cellulitis with modification to MRSA-active therapy if there is no clinical response. Seven to 14 days of therapy is recommended but should be individualized on the basis of the patient’s clinical response.

Cultures from abscesses and other purulent skin and soft-tissue infections are recommended in patients treated with antibiotic therapy, patients with severe local infection or signs of systemic illness, patients who have not responded adequately to initial treatment, and if there is concern for a cluster or outbreak.

Pediatric considerations

• For children with minor skin infections (such as impetigo) and secondarily infected skin lesions (such as eczema, ulcers, or lacerations), mupirocin 2% topical ointment can be used.
• Tetracyclines should not be used in children <8 years of age.
• In hospitalized children with complicated skin and soft-tissue infection, vancomycin is recommended. If the patient is stable without ongoing bacteremia or intravascular infection, empirical therapy with clindamycin 10–13 mg/kg/dose IV every 6–8 h (to administer 40 mg/kg/day) is an option if the clindamycin resistance rate is low (eg, <10%) with transition to oral therapy if the strain is susceptible. Linezolid 600 mg PO/IV twice daily for children ≥12 years of age and 10 mg/kg/dose PO/IV every 8 h for children <12 years of age is an alternative.

Important things to consider before taking antibiotics

There are some important things to consider before taking antibiotics.

Penicillin

Don’t take one of the penicillin-based antibiotics if you’ve had an allergic reaction to them in the past. People who are allergic to one type of penicillin will be allergic to all of them.

People with a history of allergies, such as asthma, eczema or hay fever, are at higher risk of developing a serious allergic reaction (anaphylaxis) to penicillins, although cases are rare.

Penicillins may need to be used at lower doses and with extra caution if you have:

• severe kidney disease
• liver disease

Pregnancy and breastfeeding

Most penicillins can be used during pregnancy and breastfeeding in the usual doses.

Tell your healthcare professional if you’re pregnant or breastfeeding, so they can prescribe the most suitable antibiotic for you.

Cephalosporins

If you previously had an allergic reaction to penicillin, there’s a chance that you may also be allergic to cephalosporins.

Cephalosporins may not be suitable if you have kidney disease, but if you need one you will probably be given a lower than usual dose.

If you’re pregnant or breastfeeding, or have acute porphyria, check with your doctor, midwife or pharmacist before taking cephalosporins.

Aminoglycosides

Aminoglycosides are normally only used in hospital to treat life-threatening conditions such as septicemia, as they can cause kidney damage in people with pre-existing kidney disease.

They’re only used during pregnancy if your doctor believes they’re essential.

Tetracyclines

The use of tetracyclines isn’t usually recommended unless absolutely necessary in the following groups:

• people with kidney disease – except doxycycline, which can be used
• people with liver disease
• people with the autoimmune condition lupus – which can cause skin problems, joint pain and swelling, and fatigue (feeling tired all the time)
• children under the age of 12
• pregnant or breastfeeding women

Macrolides

You shouldn’t take macrolides if you have porphyria – a rare inherited blood disorder.

If you’re pregnant or breastfeeding, the only type of macrolide you can take is erythromycin (Erymax, Erythrocin, Erythroped or Erythroped A) unless a different antibiotic is recommended by your doctor.

Erythromycin can be used at the usual doses throughout your pregnancy and while you’re breastfeeding.

Other macrolides shouldn’t be used during pregnancy, unless advised by a specialist.

Fluoroquinolones

Fluoroquinolones aren’t normally suitable for women who are pregnant or breastfeeding.

Is it safe to take antibiotics during pregnancy?

Antibiotics are commonly prescribed during pregnancy. The specific medication must be chosen carefully, however. Some antibiotics are OK to take during pregnancy, while others are not. Safety depends on various factors, including the type of antibiotic, when in your pregnancy you take the antibiotic, how much you take, what possible effects it might have on your pregnancy and for how long you’re on antibiotics.

Here’s a sampling of antibiotics generally considered safe during pregnancy:

• Penicillins, including amoxicillin, ampicillin
• Cephalosporins, including cefaclor, cephalexin
• Erythromycin
• Clindamycin

Certain other antibiotics are believed to pose risks during pregnancy. For example, tetracyclines can discolor a developing baby’s teeth. Tetracyclines aren’t recommended for use after the 15th week of pregnancy.

If an antibiotic is the best way to treat your condition, your health care provider will prescribe the safest antibiotic at the safest dosage. If you have questions or concerns about the use of an antibiotic during pregnancy, talk to your health care provider.

The best way to take antibiotics

If you are prescribed antibiotics, it is important that you follow your doctor’s advice on when, how and for how long to take them.

Be medicine wise with antibiotics

• Take your antibiotics at the right time, and for as long as directed on the packet or the patient information leaflet that comes with the medication, or as instructed by your doctor or pharmacist.
• Don’t take more than the dose your doctor has prescribed – sometimes the medicine box may contain more antibiotic pills than you will be instructed to take.
• Don’t keep unused antibiotics for another time – return leftover pills to your pharmacy for disposal.
• Don’t share antibiotics with others – they may have a different infection and this can lead to antibiotic resistance.

Doses of antibiotics can be provided in several ways:

• Oral antibiotics – tablets, capsules or a liquid that you drink, which can be used to treat most types of mild to moderate infections in the body
• Topical antibiotics – creams, lotions, sprays or drops, which are often used to treat skin infections
• Injections of antibiotics – these can be given as an injection or infusion through a drip directly into the blood or muscle, and are usually reserved for more serious infections

It’s essential to finish taking a prescribed course of antibiotics, even if you feel better, unless a healthcare professional tells you otherwise. If you stop taking an antibiotic part way through a course, the bacteria can become resistant to the antibiotic.

Missing a dose of antibiotics

If you forget to take a dose of your antibiotics, take that dose as soon as you remember and then continue to take your course of antibiotics as normal.

But if it’s almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Don’t take a double dose to make up for a missed one.

There’s an increased risk of side effects if you take two doses closer together than recommended.

Accidentally taking an extra dose

Accidentally taking one extra dose of your antibiotic is unlikely to cause you any serious harm.

But it will increase your chances of experiencing side effects, such as pain in your stomach, diarrhea, and feeling or being sick.

Antibiotic Interactions

Some antibiotics aren’t suitable for people with certain medical conditions, or women who are pregnant or breastfeeding. You should only ever take antibiotics prescribed for you – never “borrow” them from a friend or family member.

Some antibiotics can also react unpredictably with other medications, such as the oral contraceptive pill and alcohol. It’s important to read the information leaflet that comes with your medication carefully and discuss any concerns with your pharmacist or doctor.

Antibiotics can sometimes interact with other medicines or substances. This means it can have an effect that is different to what you expected.

Some of the more common interactions are listed below, but this isn’t a complete list.

If you want to check that your medicines are safe to take with your antibiotics, ask your doctor or local pharmacist.

Some antibiotics need to be taken with food, while others need to be taken on an empty stomach. You should always read the patient information leaflet that comes with your medicine.

Antibiotics and alcohol

It’s sensible to avoid drinking alcohol when taking medication or feeling unwell. But it’s unlikely that drinking alcohol in moderation will cause problems if you’re taking most common antibiotics.

To reduce the health risks associated with drinking alcohol, drink alcohol in moderation, if at all. For healthy adults, moderate drinking means up to one drink a day for women and up to two drinks a day for men.

When to avoid drinking alcohol completely

Completely avoid drinking alcohol when taking:

• metronidazole – an antibiotic sometimes used to clear dental or vaginal infections, or to clear infected leg ulcers or pressure sores
• tinidazole – an antibiotic sometimes used to treat many of the same infections as metronidazole, as well as to help clear bacteria called Helicobacter pylori (H. pylori) from the gut

Alcohol can cause a serious reaction when combined with these medications. Symptoms of this reaction can include:

• feeling or being sick
• abdominal pain
• hot flushes
• a fast or irregular heartbeat
• headaches
• dizziness
• drowziness

Because of this risk, you should avoid alcohol while you’re taking these medications. You should continue to avoid alcohol for 48 hours after you stop taking metronidazole and 72 hours after you stop taking tinidazole.

Things like mouthwash and other medicines sometimes contain alcohol, so you should also avoid using these while you’re taking metronidazole or tinidazole.

Other antibiotics that can interact with alcohol

There are some antibiotics that can sometimes interact with alcohol, so you should be wary of drinking alcohol if you’re taking:

• linezolid – linezolid can interact with undistilled (fermented) alcoholic drinks, such as wine, beer, sherry and lager
• doxycycline – this is known to interact with alcohol, and the effectiveness of doxycycline may be reduced in people with a history of chronic alcohol consumption; it should not be taken by people with liver problems

Side effects

Some antibiotics have a variety of side effects, such as causing sickness and dizziness, which might be made worse by drinking alcohol.

It’s best to avoid drinking alcohol while feeling unwell anyway, as the alcohol itself can make you feel worse.

Both metronidazole and tinidazole can cause drowsiness. Check with your pharmacist whether your antibiotic could make you drowsy.

You should not drive or operate machinery if you’re taking an antibiotic that makes you drowsy.

Contraceptives and antibiotics

Rifampicin (Rifadin, Rimycin) and rifabutin (Mycobutin) are the only antibiotics that are thought to affect how well some hormonal contraceptives work. These antibiotics are usually only used to treat serious bacterial infections like tuberculosis and methicillin-resistant Staphylococcus aureus (MRSA), and for preventing meningitis (an infection around the brain or spinal cord).

Ask your health professional for advice as you may need to use extra contraceptive precautions while you are taking rifampicin or rifabutin (and after finishing the prescribed course).

Medications and antibiotics

Some of the medications you may need to avoid, or seek advice on, while taking a specific class of antibiotic are outlined below.

Penicillins

It’s usually recommended that you avoid taking penicillin at the same time as methotrexate, which is used to treat psoriasis, rheumatoid arthritis and some forms of cancer. This is because combining the two medications can cause a range of unpleasant and sometimes serious side effects.

However, some forms of penicillin, such as amoxicillin, can be used in combination with methotrexate.

You may experience a skin rash if you take penicillin and allopurinol, which is used to treat gout.

Cephalosporins

Cephalosporins may increase the chance of bleeding if you’re taking blood-thinning medications (anticoagulants) such as heparin and warfarin.

If you need treatment with cephalosporins, you may need to have your dose of anticoagulants changed or additional blood monitoring.

Aminoglycosides

The risk of damage to your kidneys and hearing is increased if you’re taking one or more of the following medications:

• antifungals – used to treat fungal infections
• cyclosporin – used to treat autoimmune conditions such as Crohn’s disease and given to people who have had an organ transplant
• diuretics – used to remove water from the body
• muscle relaxants

The risk of kidney and hearing damage has to be balanced against the benefits of using aminoglycosides to treat life-threatening conditions such as septicemia.

In hospital, blood levels are carefully monitored to ensure the antibiotic is only present in the blood in safe amounts. If aminoglycosides are used properly in topical preparations, such as ear drops, these side effects don’t occur.

Tetracyclines

You should check with your doctor or pharmacist before taking a tetracycline if you’re currently taking any of the following:

• vitamin A supplements
• retinoids – such as acitretin, isotretinoin and tretinoin, which are used to treat severe acne
• blood-thinning medication
• diuretics
• kaolin-pectin and bismuth subsalicylate – used to treat diarrhea
• medicines to treat diabetes – such as insulin
• atovaquone – used to treat pneumonia
• antacids – used to treat indigestion and heartburn
• sucralfate – used to treat ulcers
• lithium – used to treat bipolar disorder and severe depression
• digoxin – used to treat heart rhythm disorders
• methotrexate
• strontium ranelate – used to treat osteoporosis
• colestipol or colestyramine – used to treat high cholesterol
• ergotamine and methysergide – used to treat migraines

Macrolides

It’s highly recommended that you don’t combine a macrolide with any of the following medications unless directly instructed to by your doctor, as the combination could cause heart problems:

• terfenadine, astemizole and mizolastine – these are all antihistamines used to treat allergic conditions such as hay fever
• amisulpride – used to treat episodes of psychosis
• tolterodine – used to treat urinary incontinence
• statins – used to treat high cholesterol

Fluoroquinolones

You should check with your doctor or pharmacist before taking a fluoroquinolone if you’re currently taking any of the following:

• theophylline – used to treat asthma; also found in some cough and cold medicines
• non-steroidal anti-inflammatory drug (NSAID) painkillers – such as ibuprofen
• ciclosporin
• probenecid – used to treat gout
• clozapine – used to treat schizophrenia
• ropinirole – used to treat Parkinson’s disease
• tizanadine – used to treat muscle spasms
• glibenclamide – used to treat diabetes
• cisapride – used to treat indigestion, heartburn, vomiting or nausea
• tricyclic antidepressants – such as amitriptyline
• steroid medications (corticosteroids)

Some fluoroquinolones can intensify the effects of caffeine (a stimulant found in coffee, tea and cola), which could make you feel irritable, restless and cause problems falling asleep (insomnia).

You may need to avoid taking medication that contains high levels of minerals or iron, as this can block the beneficial effects of fluoroquinolones. This includes:

• antacids
• zinc supplements
• some types of multivitamin supplements.

Side effects of antibiotics

Like all medicines, antibiotics have the potential to cause side effects. When antibiotics are necessary, the benefits far outweigh the risks, but when they are not needed, you are taking an unnecessary risk.

Up to 10% of people taking an antibiotic may experience these common side effects:

• stomach problems like diarrhea, nausea and vomiting
• bloating and indigestion
• abdominal pain
• loss of appetite
• being sick
• feeling sick
• thrush or yeast infections (Candida infection or candidiasis), which can affect the mouth (white patches will be visible) and in women can also occur in the vagina (causing itchiness, pain and discharge called vaginitis).

These side effects are usually mild and should pass once you finish your course of treatment.

Yeast infections affect different parts of the body in different ways:

• Thrush is a yeast infection that causes white patches in your mouth
• Candida esophagitis is thrush that spreads to your esophagus, the tube that takes food from your mouth to your stomach. It can make it hard or painful to swallow.
• Women can get vaginal yeast infections, causing vaginitis
• Yeast infections of the skin cause itching and rashes
• Yeast infections in your bloodstream can be life-threatening

Other less common side effects include:

• ongoing diarrhea caused by an intestinal infection, which may be serious and require further investigation and treatment
• allergic reactions, such as hives (large, red, raised areas on the skin), fever and breathing problems.

Ask your prescribing doctor about the possible side effects of your medicine. You should also ask if there are any medicines you should not take with your antibiotic.

Antibiotic allergic reactions

Around 1 in 15 people have an allergic reaction to antibiotics, especially penicillin and cephalosporins. In very rare cases, this can lead to a serious allergic reaction (anaphylaxis), which is a medical emergency.

In most cases, the allergic reaction is mild to moderate and can take the form of:

• a raised, itchy skin rash (urticaria, or hives)
• swelling of the face, lips and/or eyes
• coughing
• wheezing
• tightness of the throat, which can cause breathing difficulties

These mild to moderate allergic reactions can usually be successfully treated by taking antihistamines.

• But if you’re concerned, or your symptoms don’t respond to treatment, you should call your doctor for advice.

In rare cases, an antibiotic can cause a severe and potentially life-threatening allergic reaction known as anaphylaxis.

Initial symptoms of anaphylaxis are often the same as above and can lead to:

• a rapid heartbeat
• increasing difficulty breathing caused by swelling and tightening of the neck
• difficult/noisy breathing
• a sudden intense feeling of apprehension and fear
• a sharp and sudden drop in your blood pressure, which can make you feel light-headed and confused
• swelling of the tongue
• swelling/tightness of the throat
• difficulty talking/hoarse voice
• wheezing or coughing
• dizziness or collapse
• pale and floppy (especially young children)
• falling unconsciousness

Anaphylaxis is a medical emergency and can be life-threatening if prompt treatment isn’t given. Dial your local emergency number immediately and ask for an ambulance if you think you or someone around you is experiencing anaphylaxis.

The Society of Clinical Immunology and Allergy recommends that for a severe allergic reaction adrenaline is the initial treatment. If you are allergic to antibiotics you may be instructed by a doctor how to avoid triggers and if severe may instruct you how to use a self-administered adrenalin injection such as EpiPen®. The doctor will record the allergy and type of reaction in your notes and electronic health records and will give you an anaphylaxis action plan.

Most allergies are caused by penicillin or antibiotics closely related to penicillin, or by another type of antibiotic called sulfonamides.

Feeling nauseous and vomiting after taking antibiotics is usually a side-effect of the medicine, rather than an allergic reaction.

Your doctor can usually diagnose allergic reactions to antibiotics by talking to you. He or she may refer you to an allergy specialist, who may ask for skin allergy and blood tests.

If you have any other concerns about antibiotics, including possible side effects, contact your doctor.

Tetracyclines and sensitivity to light

Tetracyclines can make your skin sensitive to sunlight and artificial sources of light, such as sun lamps and sunbeds.

You should avoid prolonged exposure to bright light while taking these drugs.

Summary

Antibiotics are valuable therapeutic agents. Their widespread use has resulted in the emergence of many multi-resistant bacterial pathogens in hospitals and the community. In order to preserve the action of existing antibiotics, their use for prophylaxis, empiric or directed therapy should be reserved for situations where there is good evidence to support use and/or the consequences of infection are serious. It is increasingly important to avoid empiric antibiotic use for most patients with upper respiratory infections and pursue symptomatic treatment.

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