Pepto bismol

What is Pepto Bismol

Pepto-Bismol is an antacid and anti-diarrhea medication. Pepto-Bismol is used to treat diarrhea in adults and children 12 years of age and older. Pepto-Bismol is also used to relieve the symptoms of an upset stomach, such as heartburn, indigestion, and nausea in adults and children 12 years of age and older. The active ingredient in Pepto-Bismol is bismuth subsalicylate.

Pepto-Bismol is available without a prescription. However, if you are taking Pepto Bismol (bismuth subsalicylate) medicine for diarrhea, check with your doctor:

if your symptoms do not improve within 2 days or if they become worse.
if you also have a high fever.

Pepto Bismol (bismuth subsalicylate) is available in the following dosage forms:

Suspension
Tablet
Tablet, Chewable

How does Pepto Bismol work?

Pepto Bismol (bismuth subsalicylate) is in a class of medications called antidiarrheal agents. It works by decreasing the flow of fluids and electrolytes into the bowel, reduces inflammation within the intestine, and may kill the organisms that can cause diarrhea.

Why does Pepto-Bismol sometimes darken the tongue/stool and how long does it last?

This discoloration is temporary and harmless. The active ingredient in Pepto-Bismol contains bismuth. When a small amount of bismuth combines with trace amounts of sulfur in your saliva and gastrointestinal tract, a black-colored substance (bismuth sulfide) is formed. This discoloration is temporary and harmless. It can last several days after you stop taking Pepto-Bismol. Individual bowel habits, your age (the intestinal tract slows down with age), and the amount of the product taken all help to determine how long Pepto-Bismol is in your system.

Can I give Pepto-Bismol to my child?

Pepto-Bismol is indicated only for adults and children 12 years and over. Use only as directed.

For children 2 years and older, Children’s Pepto Antacid (contains Calcium Carbonate 400 mg in each Children’s Pepto Antacid chewable tablet) can be used to relieve heartburn, acid indigestion, sour stomach, and upset stomach due to these symptoms. Note the difference between Children’s Pepto Antacid that contains Calcium Carbonate unlike the actual Pepto-Bismol that contains Bismuth subsalicylate. Subsalicylate is chemically related to aspirin; therefore, includes similar warning statements to aspirin.

I have been giving Pepto-Bismol to my child when he/she had an upset stomach – should I be concerned?

Pepto-Bismol is indicated only for adults and children 12 years and over. Use only as directed.

Pepto Bismol contains both bismuth and subsalicylate. Subsalicylate is chemically related to aspirin; therefore, includes similar warning statements. Hepatic injury has been reported with chronic therapeutic use ¹. Salicylates have been linked with Reye’s syndrome in children. Hypoglycemia may develop, especially in children ¹.

The acute ingestion of less than 150 mg/kg or 6.5 g of aspirin equivalent, whichever is less, is not expected to cause significant toxicity.

In young children, the initial respiratory alkalosis from salicylate intoxication is transient, they often have a predominant metabolic acidosis (and in severe cases also respiratory alkalosis) on presentation.

What does the label say about Reye’s syndrome and Pepto-Bismol?

Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use Pepto-Bismol. When using this product, if changes in behavior with nausea or vomiting occur, consult a doctor because these symptoms could be an early sign of Reye’s syndrome, a rare but serious illness. Subsalicylate is chemically related to aspirin; therefore, includes similar warning statements.

How should Pepto Bismol be used?

Pepto Bismol (bismuth subsalicylate) comes as a liquid, tablet, or chewable tablet to be taken by mouth, with or without food. Follow the directions on the package carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take Pepto Bismol (bismuth subsalicylate) exactly as directed. Do not take more or less of it or take it more often than recommended by the manufacturer or your doctor.

Swallow the tablets whole; do not chew them.

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

If your symptoms get worse or if your diarrhea lasts longer than 48 hours, stop taking this medication and call your doctor.

Ask your doctor or pharmacist before taking other antacids or diarrhea medications together with Pepto Bismol (bismuth subsalicylate).

Should I take Pepto-Bismol with or without food?

Pepto-Bismol can be taken either with or without food. Use as directed for relief of travelers’ diarrhea, diarrhea or upset stomach due to overindulgence in food and drink, including: heartburn, indigestion, nausea, gas, belching and fullness.

When can I take Pepto-Bismol?

Pepto-Bismol is an upset stomach reliever and antidiarrheal product. It can be taken any time you are experiencing diarrhea, travelers’ diarrhea or an upset stomach due to overindulgence in food and drink, including: heartburn, indigestion, nausea, gas, belching and fullness. When using the product follow the directions. Do not exceed 8 doses in a 24 hour period when using Pepto-Bismol.

Before taking Pepto Bismol – Precautions

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

tell your doctor or pharmacist if you are allergic to salicylate pain relievers such as aspirin, choline magnesium trisalicylate, choline salicylate (Arthropan), diflunisal (Dolobid), magnesium salicylate (Doan’s, others), and salsalate (Argesic, Disalcid, Salgesic); or any other medication.
check the labels of all over-the-counter (OTC), nonprescription, and prescription medicines you now take. If any contain aspirin or other salicylates, be especially careful. Using other salicylate-containing products while taking Pepto Bismol (bismuth subsalicylate) may lead to overdose. If you have any questions about this, check with your health care professional or pharmacist.
tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to talk to your doctor or pharmacist about taking Pepto Bismol (bismuth subsalicylate) if you take: anticoagulants (‘blood thinners’) such as warfarin (Coumadin); a daily aspirin; or medication for diabetes, arthritis or gout.
if you are taking tetracycline antibiotics such as demeclocycline (Declomycin), doxycycline (Doryx, Vibramycin), minocycline (Dynacin, Minocin), and tetracycline (Sumycin), take them at least 1 hour before or 3 hours after taking Pepto Bismol (bismuth subsalicylate).
ask your doctor before taking this medication if you have ever had an ulcer, bleeding problem, stools that are bloody or blackened, or kidney disease. Also ask your doctor before taking Pepto Bismol (bismuth subsalicylate) if you have a fever or mucus in your stool. If you will be giving Pepto Bismol (bismuth subsalicylate) to a child or teenager, tell the child’s doctor if the child has any of the following symptoms before he or she receives the medication: vomiting, listlessness, drowsiness, confusion, aggression, seizures, yellowing of the skin or eyes, weakness, or flu-like symptoms. Also tell the child’s doctor if the child has not been drinking normally, has had excessive vomiting or diarrhea, or appears dehydrated.
ask your doctor about taking this medication if you are pregnant or are breast-feeding.

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

Do not take more than 8 doses in one day (24 hours).

Shake the liquid medicine well just before you measure a dose. Measure the liquid with a special dose-measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

The chewable tablet must be chewed before you swallow it.

Pepto Bismol (bismuth subsalicylate) can cause you to have a black or darkened tongue. This is a harmless side effect.

This medication can also cause unusual results with certain medical tests, thyroid scans, or stomach x-rays. Tell any doctor who treats you that you have recently taken Pepto Bismol (bismuth subsalicylate).

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Do not freeze.

Keep out of the reach of children. In case of Pepto Bismol overdose, call the Poison Control Helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help.

Overdose symptoms may include increased thirst, anxiety, muscle spasm, ringing in your ears, dizziness, confusion, severe headache, problems with speech or vision, severe stomach pain, or worsening diarrhea or vomiting.

Do not keep outdated medicine or medicine no longer needed.

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric patients

This medicine should NOT be used in children younger than 12 years of age. The fluid loss caused by diarrhea may result in a severe condition. In older children with diarrhea, medicine for diarrhea may be used, but it is also very important that a sufficient amount of liquids be given to replace the fluid lost by the body. If you have any questions about this, check with your health care professional.

Also, children are usually more sensitive to the effects of salicylates, especially if they have a fever or have lost large amounts of body fluid because of vomiting, diarrhea, or sweating.

The bismuth in Pepto Bismol may cause severe constipation in children.

In addition, do not use Pepto Bismol (bismuth subsalicylate) to treat nausea or vomiting in children or teenagers who have or are recovering from the flu or chickenpox. If nausea or vomiting is present, check with the child’s doctor immediately because this could be an early sign of Reye’s syndrome.

Geriatric patients

The fluid loss caused by diarrhea may result in a severe condition. For this reason, elderly persons with diarrhea should not take this medicine without first checking with their doctor. It is also very important that a sufficient amount of liquids be taken to replace the fluid lost by the body. If you have any questions about this, check with your health care professional.

Also, the elderly may be more sensitive to the effects of salicylates. This may increase the chance of side effects during treatment. In addition, the bismuth in this medicine may cause severe constipation in the elderly.

Breastfeeding

Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to Pepto Bismol (bismuth subsalicylate) should be prescribed or you should stop breastfeeding while using Pepto Bismol (bismuth subsalicylate).

Diabetic patients

False urine sugar test results may occur if you are regularly taking large amounts of bismuth subsalicylate or other salicylates.
Smaller doses or occasional use of Pepto Bismol (bismuth subsalicylate) usually will not affect urine sugar tests. However, check with your health care professional (especially if your diabetes is not well-controlled) if:
- you are not sure how much salicylate you are taking every day.
- you notice any change in your urine sugar test results.
- you have any other questions about this possible problem

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking Pepto Bismol (bismuth subsalicylate), it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Ask a doctor or pharmacist if it is safe for you to use Pepto Bismol (bismuth subsalicylate) if you are also using any of the following drugs:

a blood thinner such as warfarin (Coumadin, Jantoven);
insulin or oral diabetes medications;
probenecid (Benemid);
an antibiotic such as doxycycline (Doryx, Oracea, Periostat, Vibramycin), minocycline (Dynacin, Minocin, Solodyn), or tetracycline (Ala-Tet, Brodspec, Panmycin, Sumycin, Tetracap);
medication used to prevent blood clots, such as alteplase (Activase), tenecteplase (TNKase), urokinase (Abbokinase); or
other salicylates such as aspirin, Nuprin Backache Caplet, Kaopectate, KneeRelief, Pamprin Cramp Formula, Pepto-Bismol, Tricosal, Trilisate, and others.

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

Aceclofenac
Acemetacin
Amtolmetin Guacil
Bromfenac
Bufexamac
Celecoxib
Clonixin
Dexibuprofen
Dexketoprofen
Diclofenac
Digoxin
Dipyrone
Droxicam
Etodolac
Etofenamate
Etoricoxib
Felbinac
Fenoprofen
Fepradinol
Feprazone
Floctafenine
Flufenamic Acid
Flurbiprofen
Ibuprofen
Indomethacin
Ketoprofen
Lornoxicam
Loxoprofen
Lumiracoxib
Meclofenamate
Mefenamic Acid
Meloxicam
Morniflumate
Nabumetone
Naproxen
Nepafenac
Niflumic Acid
Nimesulide
Nimesulide Beta Cyclodextrin
Oxaprozin
Oxyphenbutazone
Parecoxib
Phenylbutazone
Piketoprofen
Piroxicam
Proglumetacin
Propyphenazone
Proquazone
Rofecoxib
Sulindac
Tenoxicam
Tiaprofenic Acid
Tolfenamic Acid
Tolmetin
Valdecoxib

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

Doxycycline
Probenecid
Sulfinpyrazone
Tamarind

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your Pepto Bismol (bismuth subsalicylate) with food, alcohol, or tobacco.

Pepto Bismol Pregnancy and Breastfeeding

Pepto Bismol Pregnancy Warnings

Safety has not been established during pregnancy; use is NOT recommended.

US FDA pregnancy category: Not assigned

Animal studies are inadequate. There are no controlled data in human pregnancy. Bismuth subsalicylate lacks reports of adverse fetal outcomes; however salicylates may cause congenital defects, increased perinatal mortality from ductus arteriosus in utero, intrauterine growth restriction, and salicylate intoxication.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D and X are being phased out.

Although the risk for toxicity may be small, significant fetal adverse effects have resulted from chronic exposure to salicylates Because of this, the use of bismuth subsalicyate during gestation should be restricted to the first half of pregnancy and then only in amounts that do not exceed the recommended doses ².

Pepto Bismol Breastfeeding Warnings

Use is NOT recommended.

Excreted into human milk: Yes

The excretion of large amounts of bismuth obtained from bismuth subsalicylate into breast milk is not expected because of the poor absorption of bismuth into the systemic circulation. Salicylates, however, are excreted in milk and are eliminated more slowly from milk than from plasma with milk:plasma ratios, rising from 0.03-0.08 at 3 hours to 0.34 at 12 hours ². Due to the potential for adverse effects in the nursing infant, the American Academy of Pediatrics recommends that salicylates should be used cautiously during breast feeding. A recent review also states that bismuth subsalicylate should be avoided during lactation because of systemic salicylate absorption.

Comments:

Bismuth is not expected to appear in high concentrations in breast milk due to poor systemic absorption.
Salicylates are excreted in breast milk.

What does Pepto Bismol do

Relieves travelers’ diarrhea, diarrhea and upset stomach due to over indulgence in food and drink including: heartburn, indigestion, nausea, gas, belching and fullness.

Pepto Bismol uses

Make certain your health care professional knows if you are on any special diet, such as a low-sodium or low-sugar diet.

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

For safe and effective use of Pepto Bismol (bismuth subsalicylate):

Follow your doctor’s instructions if Pepto Bismol (bismuth subsalicylate) was prescribed.
Follow the manufacturer’s package directions if you are treating yourself.

For patients using Pepto Bismol (bismuth subsalicylate) to treat diarrhea:

It is very important that the fluid lost by the body be replaced and that a proper diet be followed. For the first 24 hours you should drink plenty of clear liquids, such as ginger ale, decaffeinated cola, decaffeinated tea, broth, and gelatin. During the next 24 hours you may eat bland foods, such as cooked cereals, bread, crackers, and applesauce. Fruits, vegetables, fried or spicy foods, bran, candy, and caffeine and alcoholic beverages may make the diarrhea worse.
If too much fluid has been lost by the body due to the diarrhea a serious condition may develop. Check with your doctor as soon as possible if any of the following signs of too much fluid loss occur:
- Decreased urination
- Dizziness and lightheadedness
- Dryness of mouth
- Increased thirst
- Wrinkled skin

If you are taking the oral suspension

Use the dose cup that is included to measure out the right amount of Pepto Bismol (bismuth subsalicylate). If you are unsure, contact your doctor or pharmacist.

If you are taking the oral tablets

Swallow the tablet whole with a glass of water. Do not crush or chew the tablet.

If you are taking the chewable tablets

Chew up the tablet or allow it to completely disintegrate in your mouth before swallowing it.

Pepto Bismol Dosing

Pepto Bismol (bismuth subsalicylate) is used to treat diarrhea, nausea, heartburn, indigestion, and upset stomach.

Pepto Bismol (bismuth subsalicylate) should NOT be given to a child or teenager who has a fever, especially if the child also has flu symptoms or chicken pox. Salicylates can cause a serious and sometimes fatal condition called Reye’s syndrome in children.

You should not use Pepto Bismol (bismuth subsalicylate) if you have a stomach ulcer, a recent history of stomach or intestinal bleeding, or if you are allergic to salicylates such as aspirin, Doan’s Extra Strength, Salflex, Tricosal, and others.

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

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

For oral dosage form (Pepto Bismol suspension):

For diarrhea or upset stomach:
- Adults and children 12 years of age and older—The usual dose is 2 tablespoonfuls every half-hour to one hour if needed. You should not take more than 16 tablespoonfuls of the regular-strength suspension or 8 tablespoonfuls of the concentrate in twenty-four hours.
- Children under 12 years—Should NOT be used in children younger than 12 years of age.

For oral dosage forms (Pepto Bismol tablets or chewable tablets):

For diarrhea or upset stomach:
- Adults and children 12 years of age and older—The usual dose is 2 tablets every half-hour to one hour. You should not take more than 16 tablets in twenty-four hours.
- Children under 12 years—Should NOT be used in children younger than 12 years of age.

Usual Adult Dose for Dyspepsia

524 mg orally every 30 to 60 minutes as needed not to exceed 8 doses in any 24 hour period.

Alternatively, 1048 mg to 1050 mg may be given orally every hour not to exceed 4 doses in any 24 hour period.

Comments:

Use until diarrhea stops but not longer than 2 days.
Pepto Bismol (bismuth subsalicylate) may be useful in the prevention of traveler’s diarrhea during periods of risk. The duration of use for traveler’s diarrhea should not exceed approximately 3 weeks.
-Shake liquid formulations well before using.

Usual Adult Dose for Traveler’s Diarrhea

524 mg orally every 30 to 60 minutes as needed not to exceed 8 doses in any 24 hour period.

Alternatively, 1048 mg to 1050 mg may be given orally every hour not to exceed 4 doses in any 24 hour period.

Comments:

Use until diarrhea stops but not longer than 2 days.
Pepto Bismol (bismuth subsalicylate) may be useful in the prevention of traveler’s diarrhea during periods of risk. The duration of use for traveler’s diarrhea should not exceed approximately 3 weeks.
Shake liquid formulations well before using.

Usual Adult Dose for Diarrhea

524 mg orally every 30 to 60 minutes as needed not to exceed 8 doses in any 24 hour period.

Alternatively, 1048 mg to 1050 mg may be given orally every hour not to exceed 4 doses in any 24 hour period.

Comments:

Use until diarrhea stops but not longer than 2 days.
Pepto Bismol (bismuth subsalicylate) may be useful in the prevention of traveler’s diarrhea during periods of risk. The duration of use for traveler’s diarrhea should not exceed approximately 3 weeks.
Shake liquid formulations well before using.

Usual Adult Dose for Helicobacter pylori Infection

524 mg orally 4 times a day.

Usual Pediatric Dose for Diarrhea

Non-specific diarrhea:

<3 years: Ask your doctor
3 to 6 years: Use with caution, 87 mg every 30 minutes to 1 hour as needed.
6 to 9 years: Use with caution, 175 mg every 30 minutes to 1 hour as needed.
9 to 12 years: Use with caution, 262 mg every 30 minutes to 1 hour as needed.

Usual Pediatric Dose for Chronic Diarrhea

Chronic Infantile Diarrhea:

2 to 24 months: Use with caution, 44 mg every 4 hours
24 to 48 months: Use with caution, 87 mg every 4 hours
48 to 70 months: Use with caution, 175 mg every 4 hours

Usual Pediatric Dose for Helicobacter pylori Infection

Dosage in children with Helicobacter Pylori Infection is not well established, the following doses have been used in conjunction with ampicillin and metronidazole.

<= 10 years: 262 mg four times a day for six weeks
> 10 years: 524 mg four times a day for six weeks

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Dialysis

Data not available

What should I do if I forget a dose?

Pepto Bismol (bismuth subsalicylate) is usually taken as needed. If your doctor has told you to take Pepto Bismol (bismuth subsalicylate) regularly, take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What special dietary instructions should I follow?

Drink plenty of water or other beverages to replace fluids that you may have lost while having diarrhea.

Unless your doctor tells you otherwise, continue your normal diet.

What should I do if I forget a dose?

This medication is usually taken as needed. If your doctor has told you to take bismuth subsalicylate regularly, take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Pepto Bismol dosage

Pepto Bismol Liquid

Active Ingredient: Bismuth Subsalicylate 525 mg in each 30 ml dose

Inactive Ingredients: Benzoic Acid, D&C Red No. 22, D&C Red No. 28, Flavor, Gellan Gum, Magnesium Aluminum Silicate, Methylcellulose, Salicylic Acid, Sodium Salicylate, Sorbic Acid, Sucralose, Water

Storage Instructions

Protect from freezing. Avoid excessive heat (over 104°F or 40°C).

Pepto Bismol Liquid Usage Warning

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

Allergy alert: Contains salicylate. Do not take if you are allergic to salicylates (including aspirin), taking other salicylate products.

Do not use if you have an ulcer, a bleeding problem, bloody or black stool. Ask a doctor before use if you have: fever, mucus in the stool.

Ask a doctor or pharmacist before use if you are taking any drug for: anticoagulation (thinning the blood), diabetes, gout, arthritis. When using this product a temporary, but harmless, darkening of the stool and/or tongue may occur.

Stop use and ask a doctor if: symptoms get worse or last more than 2 days.

Pepto Bismol Liquid directions of use

Shake well before use.
Only use dose cup provided.

Pepto Bismol Liquid Dosage

Adults and children 12 years and over:
- 30 mL (1 dose) every ½ hour or 60 mL (2 doses) every hour as needed for diarrhea/traveler’s diarrhea. Use until diarrhea stops but not more than 2 days. Drink plenty of clear fluids to help prevent dehydration caused by diarrhea.
- 30 mL (1 dose) every ½ hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea).
- Do not exceed 8 doses (240 mL) in 24 hours.
Children under 12 years: ask a doctor.

Pepto-Bismol Swallowable Caplets

Active Ingredient: Bismuth Subsalicylate 262 mg in each caplet

Inactive Ingredients: Calcium Carbonate, Magnesium Stearate, Mannitol, Microcrystalline Cellulose, Polysorbate 80, Povidone, D&C Red No. 27 Aluminum Lake, Silicon Dioxide, Sodium Starch Glycolate

Storage Instructions

Avoid excessive heat (over 104°F or 40°C)

Pepto-Bismol Swallowable Caplets Usage Warning

Allergy alert: Contains salicylate. Do not take if you are allergic to salicylates (including aspirin), taking other salicylate products.

Do not use if you have an ulcer, a bleeding problem, bloody or black stool. Ask a doctor before use if you have: fever, mucus in the stool.

Stop use and ask a doctor if: symptoms get worse or last more than 2 days.

Pepto-Bismol Swallowable Caplets directions of use

Swallow whole with water, do not chew.

Pepto-Bismol Swallowable Caplets Dosage

Adults and children 12 years and over:
- 2 caplets (1 dose) every ½ hour or 4 caplets (2 doses) every hour as needed for diarrhea. Use until diarrhea stops but not more than 2 days. Drink plenty of clear fluids to help prevent dehydration caused by diarrhea.
- 2 caplets (1 dose) every ½ hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea).
- Do not exceed 8 doses (16 caplets) in 24 hours.
Children under 12 years: ask a doctor.

Pepto-Bismol Original Chewable Tablets

Active Ingredient: Bismuth Subsalicylate 262 mg in each chewable tablet

Inactive Ingredients: Calcium Carbonate, Flavor, Magnesium Stearate, Mannitol, Povidone, D&C Red No. 27, Saccharin Sodium, Talc

Storage Instructions

Avoid excessive heat (over 104°F or 40°C)

Pepto-Bismol Original Chewable Tablets Usage Warning

Allergy alert: Contains salicylate. Do not take if you are allergic to salicylates (including aspirin), taking other salicylate products.

Do not use if you have an ulcer, a bleeding problem, bloody or black stool. Ask a doctor before use if you have: fever, mucus in the stool.

Stop use and ask a doctor if: symptoms get worse or last more than 2 days.

Pepto-Bismol Original Chewable Tablets directions of use

Chew or dissolve in mouth.

Pepto-Bismol Original Chewable Tablets Dosage

Adults and children 12 years and over:
- 2 tablets (1 dose) every ½ hour or 4 tablets (2 doses) every hour as needed for diarrhea. Use until diarrhea stops but not more than 2 days. Drink plenty of clear fluids to help prevent dehydration caused by diarrhea.
- 2 tablets (1 dose) every ½ hour as needed for overindulgence (upset stomach, heartburn, indgestion and nausea).
- Do not exceed 8 doses (16 tablets) in 24 hours.
Children under 12 years: ask a doctor.

Children’s Pepto Antacid

Active Ingredient: Calcium Carbonate 400 mg in each Children’s Pepto Antacid chewable tablet

Inactive Ingredients: D&C Red No.27 Aluminum Lake, Flavor, Magnesium Stearate, Mannitol, Povidone, Sorbitol, Sugar, Talc

Storage Instructions

Do not exceed 25°C. Preserve in well-closed containers.

Children’s Pepto Antacid Chewable Tablets Usage Warning

Ask a doctor or pharmacist before use if the child is presently taking a prescription drug. Antacids may interact with certain prescription drugs. Stop use and ask a doctor if symptoms last more than two weeks. Keep this and all drugs out of the reach of children.

Children’s Pepto Antacid Chewable Tablets directions of use

Ask a doctor or pharmacist before use.

Children’s Pepto Antacid Chewable Tablets Dosage

Find the right dose on the chart below based on weight (preferred). Otherwise, use age. Repeat dose as needed. Do not take more than 3 tablets (ages 2-5) or 6 tablets (ages 6-11) in a 24-hour period, or use the maximum dosage for more than two weeks, except under the advice and supervision of a doctor.

Under 24 lbs or under 2 years: Ask a doctor
24-47 lbs or 2-5 years: 1 Children’s Pepto Antacid tablet
48-95 lbs or 6-11 years: 2 Children’s Pepto Antacid tablets
Do not take more than 3 tablets (ages 2-5) or 6 tablets (ages 6-11) in a 24-hour period.

Pepto Bismol side effects

Along with Pepto Bismol (bismuth subsalicylate) needed effects, Pepto Bismol (bismuth subsalicylate) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Common side effects include:

constipation
dark colored stools
black or darkened tongue.

Check with your doctor immediately if any of the following side effects occur:

In some patients Pepto Bismol (bismuth subsalicylate) may cause dark tongue and/or grayish black stools. This is only temporary and will go away when you stop taking this medicine.

Pepto Bismol side effects

anxiety
any loss of hearing
confusion
constipation (severe)
diarrhea (severe or continuing)
difficulty in speaking or slurred speech
dizziness or lightheadedness
drowsiness (severe)
fast or deep breathing
headache (severe or continuing)
increased sweating
increased thirst
mental depression
muscle spasms (especially of face, neck, and back)
muscle weakness
nausea or vomiting (severe or continuing)
ringing or buzzing in ears (continuing)
stomach pain (severe or continuing)
trembling
uncontrollable flapping movements of the hands (especially in elderly patients) or other uncontrolled body movements
vision problems

Nervous system

Rare (less than 0.1%): Myoclonic encephalopathy
Frequency not reported: Weakness, fatigue, depression, anxiety, irritability, insomnia, unsteady gait, motor incoordination, loss of memory, jerky movements, mental confusion, disorientation, difficulty in walking and speaking, tremor, myoclonic jerks, incontinence

Nervous system toxicity is a common feature of bismuth toxicity. Bismuth toxicity is characterized by the insidious onset of weakness and fatigue, depression, anxiety, irritability, insomnia, unsteady gait, motor incoordination, loss of memory, and jerky movements. Acute toxicity may result in the development of mental confusion, disorientation, difficulty in walking and speaking, tremor, myoclonic jerks, and incontinence.

Myoclonic encephalopathy has occurred in patients who have ingested bismuth for several months to years, but the incidence is very rare. Recovery of patients from bismuth encephalopathy may take several months following discontinuation of use. Bismuth encephalopathy has generally been reported in patients ingesting salts other than subsalicylate.

Other

Salicylism has been reported in patients who chronically ingest bismuth subsalicylate (the active ingredient contained in Pepto-Bismol). Common complaints include vertigo, diminished hearing, lethargy, CNS (central nervous system) dysfunction, confusion, tinnitus, vomiting, and abdominal pain. Patients may present with respiratory alkalosis and metabolic acidosis, azotemia, and hypoprothrombinemia and platelet dysfunction. The elderly may be particularly vulnerable to the development of salicylism.

Frequency not reported: Salicylism

Gastrointestinal

Very common (10% or more): Black stool
Common (1% to 10%): Black tongue
Frequency not reported: Nausea, vomiting

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

Some side effects can be serious.

If you experience this symptom, stop taking this medication and call your doctor immediately:

ringing or buzzing in your ear(s)
diarrhea lasting longer than 2 days
worsened stomach symptoms.

Pepto Bismol (bismuth subsalicylate) may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

Human Toxicity Reports

Six examples of poisoning by bismuth subsalicylate were reported ³ arising from treatment of syphilis involving the simultaneous occurrence of stomatitis and albuminuria. The study author noted that bismuth tended to be mobilized during acidosis and advised caution in administration of bismuth to patients subject to acidosis ³.

A case was described in which encephalopathy occurred in a 60 year old man that was attributed to use of bismuth subsalicylate for diarrhea ⁴. The diagnosis was supported by an electroencephalogram and a blood bismuth level of 72 uG/L. The patient recovered completely within one month after the drug was discontinued ⁴.

Inorganic bismuth salts, formed from metabolism of bismuth subsalicylate in the gastrointestinal tract, apparently present little or no risk to the fetus from normal therapeutic doses, but the data available for bismuth in pregnancy are poor, and the actual fetal risk cannot be determined ². On the other hand, the potential actions of salicylate on the fetus are complex. Although the risk for toxicity may be small, significant fetal adverse effects have resulted from chronic exposure to salicylates. Because of this, the use of bismuth subsalicyate during gestation should be restricted to the first half of pregnancy and then only in amounts that do not exceed the recommended doses ².

Bioavailability of doxycycline was significantly reduced by 37% and 51% respectively, when bismuth subsalicylate was given simultaneously and as a multiple dose regimen before doxycycline. Bismuth subsalicylate should not be taken when doxycycline is used for therapeutic purposes. The study authors suggest travelers should not take these agents together to prevent diarrhea ⁵.

Pepto Bismol overdose

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

Moderately toxic and probable oral lethal dose in human is 500mg to 5,000mg per kg body weight for a 70 kg (150 lb) person ⁶.

If you think that you or anyone else may have taken a Pepto Bismol overdose, get emergency help at once. Taking an overdose of Pepto Bismol (bismuth subsalicylate) may cause unconsciousness or death. Signs of overdose include convulsions (seizures), hearing loss, confusion, ringing or buzzing in the ears, severe drowsiness or tiredness, severe excitement or nervousness, and fast or deep breathing.

BISMUTH SUBSALICYLATE. https://toxnet.nlm.nih.gov/cgi-bin/sis/search2/f?./temp/~nTtVSk:1[↩][↩]
Briggs, G.G, R.K. Freeman, S.J. Yaffe. A Reference Guide to Fetal and Neonatal Risk. Drugs in Pregnancy and Lactation. 4th ed. Baltimore, MD: Williams & Wilkins 1994., p. 96[↩][↩][↩][↩]
Hayes, W.J., Jr., E.R. Laws, Jr., (eds.). Handbook of Pesticide Toxicology. Volume 2. Classes of Pesticides. New York, NY: Academic Press, Inc., 1991., p. 543[↩][↩]
HASKING GJ, DUGGAN JM; MED J AUST 2 (AUG 21): 167;1982[↩][↩]
Influence of Subsalicylate Bismuth on Absorption of Doxycycline; JAMA 247 (16): 2266; 1982 https://jamanetwork.com/journals/jama/article-abstract/371748[↩]
Gosselin, R.E., H.C. Hodge, R.P. Smith, and M.N. Gleason. Clinical Toxicology of Commercial Products. 4th ed. Baltimore: Williams and Wilkins, 1976., p. II-93[↩]

Zantac

11.3K views

What is Zantac

Zantac (Ranitidine) is in a class of medications called histamine-2 blockers (H2 blockers). Zantac active ingredient is called Ranitidine, which is a histamine-2 antagonist or H2 blocker. Zantac (Ranitidine) works by reducing the amount of acid your stomach produces. Histamine is a chemical that occurs naturally in the body. It encourages your stomach to produce acid which it needs to digest your food. By blocking the histamine, Zantac (Ranitidine) reduces the amount of acid your stomach produces. Having less acid in your stomach allows ulcers and inflammation to heal. If your foodpipe (esophagus) has been damaged by stomach acid, this will also have a chance to heal.

Zantac (Ranitidine) is used to treat and prevent ulcers in the stomach and intestines. Zantac (Ranitidine) also treats conditions in which the stomach produces too much acid, such as Zollinger-Ellison syndrome. Zantac (Ranitidine) also treats gastroesophageal reflux disease (GERD) and other conditions in which acid backs up from the stomach into the esophagus, causing heartburn and injury of the food pipe (esophagus).

Over-the-counter Zantac (Ranitidine) is used to prevent and treat symptoms of heartburn associated with acid indigestion and sour stomach.

Key facts

It’s usual to take Zantac (Ranitidine) once or twice a day.
Some people only need to take Zantac (Ranitidine) for a short time, when they have symptoms. Others need to take it for longer.
You can take Zantac (Ranitidine) with or without food.
It’s unusual to get any side effects. However, some people may get stomach pain or constipation, or feel sick (nausea). This tends to get better as you carry on taking Zantac (Ranitidine).
Ranitidine is called by the brand names Zantac, Zantac 75, Zantac EFFERdose, Zantac Syrup and Taladine

How long does Zantac take to work

Your indigestion and heartburn should start to feel better within 1 or 2 hours. The effects will usually last for around 12 hours.

It may take a few weeks for Zantac (Ranitidine) to work properly. Depending on your problems, you may still have some acid symptoms during this time.

If you’re taking Zantac (Ranitidine) to prevent stomach ulcers, however, you may not feel any different. Carry on taking your medicine. It will still be working.

How long will I take Zantac for?

If you’re taking lower strength Zantac (Ranitidine) (75mg) that you bought from a pharmacy or supermarket, speak to a pharmacist or doctor before starting on a second packet. They may recommend tests to find out what’s causing your symptoms, if taking Zantac (Ranitidine) hasn’t cleared them up.

If your doctor prescribes Zantac (Ranitidine) for you, you may only need to take it for a few weeks or months, depending on your health problem. Sometimes you might need to take it for longer.

Your doctor may suggest taking Zantac (Ranitidine) only when you have symptoms. This means you won’t have to take it every day. Once you feel better, you can stop taking it – often after a few days or weeks.

Taking Zantac (Ranitidine) this way isn’t suitable for everyone. Speak to your doctor about what’s best for you.

Although Zantac (Ranitidine) appears to only minimally affect the secretion of gastric intrinsic factor, malabsorption of, and resultant deficiency in vitamin B12 may occur during long-term ranitidine therapy ¹.

Zantac side effects long term

It’s usually best to take Zantac (Ranitidine) for a short time. You might take it for a month or two, for example, until your stomach heals. Some people may take it every now and again when they have symptoms. You may find that Zantac (Ranitidine) stops working and your symptoms come back if you take it for longer than this.

If you’re taking Zantac (Ranitidine) to treat Zollinger Ellison syndrome or another long term problem, however, you may need to take it for longer. In this case, follow your doctor’s instructions about the best way to take it.

Are there similar medicines to Zantac?

There are 3 other medicines that are similar to Zantac (Ranitidine). They are cimetidine, famotidine and nizatidine.

Like Zantac (Ranitidine), these medicines are H2 blockers. They work in the same way as Zantac (Ranitidine) to reduce the amount of acid in your stomach.

Famotidine and nizatidine generally work as well as Zantac (Ranitidine) and have similar side effects. However they may suit some people better.

Cimetidine can interfere with lots of medicines and has more side effects than other H2 blockers.

Are there other indigestion medicines?

Yes there are other pharmacy and prescription medicines for indigestion and heartburn.

Antacids, like calcium carbonate (Tums or Mylanta), sodium bicarbonate (Neut), Maalox and Milk of Magnesia, relieve indigestion and heartburn by neutralizing the acid in your stomach. They give quick relief that lasts for a few hours. They’re ideal for occasional stomach acid symptoms.

Some antacids, such as Gaviscon, have an extra ingredient called alginic acid. They work by lining your stomach so that juices from it don’t splash up into your foodpipe. They’re especially good for relieving acid reflux.

Antacids are available from pharmacies and supermarkets.

Proton pump inhibitors (PPIs) reduce the amount of acid made in your stomach, but they do this in a different way to H2 blockers.

They include esomeprazole (Nexium), lansoprazole (Zoton FasTabs), omeprazole (Losec), pantoprazole (Pantoloc Control) and rabeprazole (Pariet).

In general, proton pump inhibitors (PPIs) are used first because they are better than H2 blockers at reducing stomach acid. Your doctor may prescribe an H2 blocker if you don’t get on with a proton pump inhibitor (PPI) – for example because of the side effects.

Lansoprazole and rabeprazole are only available on prescription but you can buy omeprazole, esomeprazole and pantoprazole directly from pharmacies. You can also buy esomeprazole from supermarkets.

Can I take Zantac with other indigestion medicines?

Some antacids are okay to take at the same time as Zantac (Ranitidine). Other antacids, such as Gaviscon, need to be taken a certain amount of time before or after you take the Zantac (Ranitidine). Check the instructions on the packet to see how long you need to wait between medicines.

Sometimes, depending on your symptoms, your doctor may prescribe an H2 blocker as well as a proton pump inhibitor. This will often be for a short time and you’ll usually take the H2 blocker at night.

If you’re prescribed sucralfate (a medicine to treat ulcers), take it at least 2 hours after Zantac (Ranitidine). This is because sucralfate can stop your body from properly absorbing the Zantac (Ranitidine).

Can I drive or ride a bike after taking Zantac?

Occasionally, Zantac (Ranitidine) can make you feel dizzy or sleepy, or give you blurred vision. If this happens to you, don’t drive, cycle or use machinery or tools until you feel better.

Furthermore, the amount of alcohol contained in a large dose of Zantac (Ranitidine) liquid may affect your ability to drive or operate machines. In this case, do not attempt to drive or use any machinery.

Can I drink alcohol with Zantac?

Yes, you can drink alcohol with Zantac (Ranitidine) but be aware that Zantac (Ranitidine) liquid also contains a small amount of alcohol.

Also, drinking alcohol makes your stomach produce more acid than normal. This can irritate your stomach lining and make your symptoms worse.

Is there any food or drink I need to avoid?

You can eat and drink normally while taking Zantac (Ranitidine).

However, it’s best to avoid foods that seem to make your indigestion worse, such as rich, spicy and fatty foods. You may also want to cut down on caffeinated drinks, such as tea, coffee and cola, as well as alcohol.

Can lifestyle changes help?

It may be possible to ease symptoms caused by too much stomach acid by making a few changes to your diet and lifestyle:

lose excess weight
don’t eat foods that can make your symptoms worse, such as rich, spicy and fatty foods, and acidic foods like tomatoes, citrus fruits, salad dressings and fizzy drinks
cut down on caffeinated drinks, such as tea, coffee and cola, as well as alcohol and smoking
if you have symptoms at night, try not to eat for at least 3 hours before you go to bed
raise the head of your bed by 10 to 20cm, so your head and chest are higher than your waist

Who can and can’t take Zantac

Zantac (Ranitidine) can be taken by adults. It can also be given to children under 16 years of age on prescription.

Zantac (Ranitidine) isn’t suitable for some people. To make sure that it is safe for you, tell your doctor if you:

have had an allergic reaction to Zantac (Ranitidine) or any other medicines in the past
have kidney problems
have an intolerance to, or cannot absorb, some sugars such as fructose
have been advised to eat a low calcium or low salt diet
cannot have alcohol – Zantac (Ranitidine) liquid contains a small amount of alcohol
have phenylketonuria (PKU), a rare inherited illness

If you’re due to have an endoscopy to find out what’s causing your symptoms, stop taking Zantac (Ranitidine) at least 2 weeks before your procedure. This is because Zantac (Ranitidine) may hide some of the problems that would usually be spotted during an endoscopy.

Pediatric Use

The safety and effectiveness of Zantac have been established in the age-group of 1 month to 16 years for the treatment of duodenal and gastric ulcers, gastroesophageal reflux disease and erosive esophagitis, and the maintenance of healed duodenal and gastric ulcer. Use of Zantac in this age-group is supported by adequate and well-controlled trials in adults, as well as additional pharmacokinetic data in pediatric patients and an analysis of the published literature.

Safety and effectiveness in pediatric patients for the treatment of pathological hypersecretory conditions or the maintenance of healing of erosive esophagitis have not been established.

Safety and effectiveness in neonates (aged younger than 1 month) have not been established.

Geriatric Use

Of the total number of subjects enrolled in US and foreign controlled clinical trials of oral formulations of Zantac, for which there were subgroup analyses, 4,197 were aged 65 and older, while 899 were aged 75 and older. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

This drug is known to be substantially excreted by the kidney and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, caution should be exercised in dose selection, and it may be useful to monitor renal function.

Pregnancy and breastfeeding

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

Usually, Zantac (Ranitidine) is safe to take during pregnancy and while breastfeeding. Animal models have failed to reveal evidence of impaired fertility or fetal harm. It is unknown whether use of gastric-suppressing drugs are associated with childhood allergy and asthma. There are no controlled data in human pregnancy.

If you’re pregnant, it’s always better to try to treat indigestion without taking a medicine.

Your doctor or midwife will first advise you to try to ease your symptoms by eating smaller meals more often, and not eating fatty and spicy foods. They may also suggest raising the head of your bed by 10 to 20cm, so your head and chest are higher than your waist. This will help stop stomach acid travelling up towards your throat.

If these lifestyle changes don’t work, you may be recommended a medicine like Zantac (Ranitidine).

Teratogenic Effects

Pregnancy Category B. Reproduction studies have been performed in rats and rabbits at doses up to 160 times the human dose and have revealed no evidence of impaired fertility or harm to the fetus due to Zantac (Ranitidine). There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Carcinogenesis, Mutagenesis, Impairment of Fertility

There was no indication of tumorigenic or carcinogenic effects in life-span studies in mice and rats at dosages up to 2,000 mg/kg/day.

Zantac (Ranitidine) was not mutagenic in standard bacterial tests (Salmonella, Escherichia coli) for mutagenicity at concentrations up to the maximum recommended for these assays.

In a dominant lethal assay, a single oral dose of 1,000 mg/kg to male rats was without effect on the outcome of 2 matings per week for the next 9 weeks.

Zantac and breastfeeding

Zantac (Ranitidine) is safe to take while you’re breastfeeding. It passes into breast milk, but only in small amounts which aren’t harmful to the baby.

However, if your baby is premature or has health problems check with your doctor first.

Cautions with other medicines

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

Some medicines can interfere with Zantac (Ranitidine) and make you more likely to have side effects.

Tell your doctor if you’re taking these medicines before you start taking Zantac (Ranitidine):

anti-fungal medicines such as itraconazole, ketoconazole or posaconazole
any medicine used to treat cancer
HIV medicines

Zantac (Ranitidine) has been reported to affect the bioavailability of other drugs through several different mechanisms such as competition for renal tubular secretion, alteration of gastric pH, and inhibition of cytochrome P450 enzymes.

Procainamide: Zantac (Ranitidine), a substrate of the renal organic cation transport system, may affect the clearance of other drugs eliminated by this route. High doses of Zantac (Ranitidine) (e.g., such as those used in the treatment of Zollinger-Ellison syndrome) have been shown to reduce the renal excretion of procainamide and N-acetylprocainamide resulting in increased plasma levels of these drugs. Although this interaction is unlikely to be clinically relevant at usual Zantac (Ranitidine) doses, it may be prudent to monitor for procainamide toxicity when administered with oral Zantac (Ranitidine) at a dose exceeding 300 mg per day.

Warfarin: There have been reports of altered prothrombin time among patients on concomitant warfarin and Zantac (Ranitidine) therapy. Due to the narrow therapeutic index, close monitoring of increased or decreased prothrombin time is recommended during concurrent treatment with Zantac (Ranitidine).

Zantac (Ranitidine) may alter the absorption of drugs in which gastric pH is an important determinant of bioavailability. This can result in either an increase in absorption (e.g., triazolam, midazolam, glipizide) or a decrease in absorption (e.g., ketoconazole, atazanavir, delavirdine, gefitinib). Appropriate clinical monitoring is recommended.

Atazanavir: Atazanavir absorption may be impaired based on known interactions with other agents that increase gastric pH. Use with caution. See atazanavir label for specific recommendations.

Delavirdine: Delavirdine absorption may be impaired based on known interactions with other agents that increase gastric pH. Chronic use of H2-receptor antagonists with delavirdine is not recommended.

Gefitinib: Gefitinib exposure was reduced by 44% with the coadministration of Zantac (Ranitidine) and sodium bicarbonate (dosed to maintain gastric pH above 5.0). Use with caution.

Glipizide: In diabetic patients, glipizide exposure was increased by 34% following a single 150-mg dose of oral Zantac (Ranitidine). Use appropriate clinical monitoring when initiating or discontinuing Zantac (Ranitidine).

Ketoconazole: Oral ketoconazole exposure was reduced by up to 95% when oral Zantac (Ranitidine) was coadministered in a regimen to maintain a gastric pH of 6 or above. The degree of interaction with usual dose of Zantac (Ranitidine) (150 mg twice daily) is unknown.

Midazolam: Oral midazolam exposure in 5 healthy volunteers was increased by up to 65% when administered with oral Zantac (Ranitidine) at a dose of 150 mg twice daily. However, in another interaction trial in 8 volunteers receiving IV midazolam, a 300-mg oral dose of Zantac (Ranitidine) increased midazolam exposure by about 9%. Monitor patients for excessive or prolonged sedation when Zantac (Ranitidine) is coadministered with oral midazolam.

Triazolam: Triazolam exposure in healthy volunteers was increased by approximately 30% when administered with oral Zantac (Ranitidine) at a dose of 150 mg twice daily. Monitor patients for excessive or prolonged sedation.

These are not all the medicines that may not mix well with Zantac (Ranitidine). For a full list see the leaflet inside your medicines packet.

Mixing Zantac (Ranitidine) with herbal remedies and supplements

There isn’t enough research to know if complementary medicines and herbal remedies are safe to take with Zantac (Ranitidine).

What is Zantac used for

Zantac (Ranitidine) comes as a tablet, an effervescent tablet, effervescent granules, and a syrup to take by mouth. It is usually taken once a day at bedtime or two to four times a day. Over-the-counter Zantac (Ranitidine) comes as a tablet to take by mouth. It is usually taken once or twice a day. To prevent symptoms, it is taken 30 to 60 minutes before eating or drinking foods that cause heartburn. Follow the directions on your prescription or the package label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take Zantac (Ranitidine) exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Dissolve Zantac (Ranitidine) effervescent tablets and granules in a full glass (6 to 8 ounces [180 to 240 milliliters]) of water before drinking.

Do not take over-the-counter Zantac (Ranitidine) for longer than 2 weeks unless your doctor tells you to. If symptoms of heartburn, acid indigestion, or sour stomach last longer than 2 weeks, stop taking Zantac (Ranitidine) and call your doctor.

Zantac (Ranitidine) is also used sometimes to treat upper gastrointestinal bleeding and to prevent stress ulcers, stomach damage from use of nonsteroidal anti-inflammatory drugs (NSAIDs), and aspiration of stomach acid during anesthesia. Talk to your doctor about the risks of using this medication for your condition.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Zantac uses

Zantac (Ranitidine) reduces the amount of acid your stomach makes.

Short-term treatment of active duodenal ulcer. Most patients heal within 4 weeks. Trials available to date have not assessed the safety of Zantac (Ranitidine) in uncomplicated duodenal ulcer for periods of more than 8 weeks.
Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of acute ulcers. No placebo-controlled comparative trials have been carried out for periods of longer than 1 year.
The treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome and systemic mastocytosis).
Short-term treatment of active, benign gastric ulcer. Most patients heal within 6 weeks and the usefulness of further treatment has not been demonstrated. Trials available to date have not assessed the safety of Zantac (Ranitidine) in uncomplicated, benign gastric ulcer for periods of more than 6 weeks.
Maintenance therapy for gastric ulcer patients at reduced dosage after healing of acute ulcers. Placebo-controlled trials have been carried out for 1 year.
Treatment of gastro-esophageal reflux disease (GERD). Symptomatic relief commonly occurs within 24 hours after starting therapy with Zantac 150 mg twice daily.
Treatment of endoscopically diagnosed erosive esophagitis. Symptomatic relief of heartburn commonly occurs within 24 hours of therapy initiation with Zantac 150 mg 4 times daily.
Maintenance of healing of erosive esophagitis. Placebo-controlled trials have been carried out for 48 weeks.

Concomitant antacids should be given as needed for pain relief to patients with active duodenal ulcer; active, benign gastric ulcer; hypersecretory states; GERD; and erosive esophagitis.

Zantac (Ranitidine) is also taken to prevent and treat stomach ulcers.

Sometimes, Zantac (Ranitidine) is taken for a rare illness caused by a tumor in the pancreas or gut called Zollinger-Ellison syndrome.

Zantac (Ranitidine) comes as tablets, soluble (dispersible) tablets that dissolve in water to make a drink, or as a liquid that you drink.

All types of Zantac (Ranitidine) are available on prescription. You can also buy the lowest strength 75mg tablets from pharmacies and supermarkets.

Before taking Zantac – Precautions

tell your doctor and pharmacist if you are allergic to Zantac (Ranitidine) or any other medications.
tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking. Be sure to mention either of the following: anticoagulants (‘blood thinners’) such as warfarin (Coumadin); and triazolam (Halcion). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
tell your doctor if you have or have ever had porphyria, phenylketonuria, or kidney or liver disease.
tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking Zantac (Ranitidine), call your doctor.
Using Zantac may increase your risk of developing pneumonia. Symptoms of pneumonia include chest pain, fever, feeling short of breath, and coughing up green or yellow mucus. Talk with your doctor about your specific risk of developing pneumonia.

How and when to take Zantac

It’s usual to take Zantac (Ranitidine) twice a day – 1 dose in the morning and 1 dose in the evening. Some people only need to take Zantac (Ranitidine) once a day, at bedtime.

Very young babies, and people with Zollinger-Ellison syndrome, usually take Zantac (Ranitidine) 3 times a day. People with severe inflammation of the food pipe (esophagitis) may need to take it 4 times a day.

How to take Zantac

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

Your doctor may recommend an antacid to help relieve pain. Carefully follow your doctor’s directions about the type of antacid to use, and when to use it.

You can take Zantac (Ranitidine) with or without food. However, if you get symptoms whenever you eat or drink, take your medicine 30 minutes to 60 minutes before having a drink, snack or meal.

Tablets – swallow tablets whole with a glass of water, milk or juice.
Soluble tablets – dissolve tablets in half a glass of water. Do not use milk, fizzy water or other fizzy drinks. Wait until the medicine has completely dissolved and then drink it straight away.
Liquid – this comes with a syringe or spoon to help you measure it. If you don’t have a syringe or spoon, ask your pharmacist for one. Do not use a kitchen teaspoon as it won’t give you the right amount.

Liquid Zantac (Ranitidine) is suitable for children and people who find it difficult to swallow tablets.

Do not crush, chew, or break the Zantac effervescent tablet, and do not allow it to dissolve on your tongue. The 25-milligram effervescent tablet must be dissolved in at least 1 teaspoon of water before swallowing. The150-milligram effervescent tablet should be dissolved in 6 to 8 ounces of water.

Allow the Zantac effervescent tablet to dissolve completely in the water, and then drink the entire mixture. If you are giving this medicine to a child, you may draw the liquid mixture into a medicine dropper and empty the dropper into the child’s mouth.

Zantac granules should be mixed with 6 to 8 ounces of water before drinking.

Measure Zantac liquid with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

It may take up to 8 weeks before your ulcer heals. Keep using the medication as directed and tell your doctor if your symptoms do not improve after 6 weeks of treatment.

This medication can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using Zantac.

Store Zantac at room temperature away from moisture, heat, and light.

How much Zantac will I take?

Each tablet contains 75mg, 150mg or 300mg of Zantac (Ranitidine). You can buy 75mg tablets in pharmacies and supermarkets. Soluble tablets, and 150mg and 300mg tablets are only available on prescription.

The usual dose to treat:

indigestion or heartburn is 75mg to 300mg a day
stomach ulcers and inflammation of the food pipe is 300mg to 600mg a day
Zollinger-Ellison syndrome is 450mg to 6 grams a day

Zantac (Ranitidine) liquid comes in 2 different strengths – your daily dose will depend on what your doctor prescribes. Follow your doctor’s advice about how much Zantac (Ranitidine) to take and when.

Doses are usually lower for children and people with kidney problems.

If a doctor prescribes Zantac (Ranitidine) for your child, they will use your child’s weight or age to work out the right dose.

Zantac Dosage

Active Duodenal Ulcer:

The current recommended adult oral dosage of Zantac for duodenal ulcer is 150 mg twice daily. An alternative dosage of 300 mg once daily after the evening meal or at bedtime can be used for patients in whom dosing convenience is important. The advantages of one treatment regimen compared with the other in a particular patient population have yet to be demonstrated. Smaller doses have been shown to be equally effective in inhibiting gastric acid secretion in US trials, and several foreign trials have shown that 100 mg twice daily is as effective as the 150-mg dose.

Antacid should be given as needed for relief of pain.

Maintenance of Healing of Duodenal Ulcers:

The current recommended adult oral dosage is 150 mg at bedtime.

Pathological Hypersecretory Conditions (such as Zollinger-Ellison syndrome):

The current recommended adult oral dosage is 150 mg twice daily. In some patients it may be necessary to administer Zantac 150-mg doses more frequently. Dosages should be adjusted to individual patient needs, and should continue as long as clinically indicated. Dosages up to 6 g/day have been employed in patients with severe disease.

Benign Gastric Ulcer:

The current recommended adult oral dosage is 150 mg twice daily.

Maintenance of Healing of Gastric Ulcers:

The current recommended adult oral dosage is 150 mg at bedtime.

Gastro-esophageal reflux disease (GERD):

The current recommended adult oral dosage is 150 mg twice daily.

Erosive Esophagitis:

The current recommended adult oral dosage is 150 mg 4 times daily.

Maintenance of Healing of Erosive Esophagitis:

The current recommended adult oral dosage is 150 mg twice daily.

Pediatric Use:

The safety and effectiveness of Zantac have been established in the age-group of 1 month to 16 years. There is insufficient information about the pharmacokinetics of Zantac in neonatal patients (aged younger than 1 month) to make dosing recommendations.

The following 3 subsections provide dosing information for each of the pediatric indications.

Treatment of Duodenal and Gastric Ulcers: The recommended oral dose for the treatment of active duodenal and gastric ulcers is 2 to 4 mg/kg twice daily to a maximum of 300 mg/day. This recommendation is derived from adult clinical trials and pharmacokinetic data in pediatric patients.
Maintenance of Healing of Duodenal and Gastric Ulcers: The recommended oral dose for the maintenance of healing of duodenal and gastric ulcers is 2 to 4 mg/kg once daily to a maximum of 150 mg/day. This recommendation is derived from adult clinical trials and pharmacokinetic data in pediatric patients.
Treatment of GERD and Erosive Esophagitis: Although limited data exist for these conditions in pediatric patients, published literature supports a dosage of 5 to 10 mg/kg/day, usually given as 2 divided doses.

Dosage Adjustment for Patients with Impaired Renal Function:

On the basis of experience with a group of subjects with severely impaired renal function treated with Zantac, the recommended dosage in patients with a creatinine clearance <50 mL/min is 150 mg every 24 hours. Should the patient’s condition require, the frequency of dosing may be increased to every 12 hours or even further with caution. Hemodialysis reduces the level of circulating ranitidine. Ideally, the dosing schedule should be adjusted so that the timing of a scheduled dose coincides with the end of hemodialysis.

Elderly patients are more likely to have decreased renal function, therefore caution should be exercised in dose selection, and it may be useful to monitor renal function.

Will my dose go up or down?

Sometimes your doctor will increase your dose of Zantac (Ranitidine) if it isn’t working well enough.

Depending on the reason you take Zantac (Ranitidine), you may take a higher dose to start with – usually for at least 1 month. After this, your doctor may recommend a lower dose.

What if I forget to take Zantac?

If you usually take it:

once a day, take the missed dose as soon as you remember, unless it’s less than 12 hours until your next dose – in which case skip the missed dose
twice a day, take the missed dose as soon as you remember, unless it’s nearly time for your next dose – in which case skip the missed dose
3 or 4 times a day, skip the missed dose and take your next dose as normal

Do NOT take a double dose to make up for a forgotten dose.

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

What if I take too much Zantac?

Zantac (Ranitidine) is generally very safe. Taking too much is unlikely to harm you or your child.

If you take an extra dose by mistake, you might get some side effects, such as feeling sick. Call your doctor if you’re worried, or you’re bothered by side effects.

Zantac dosage

Zantac 75

Active ingredient (in each tablet): Ranitidine 75 mg (as ranitidine hydrochloride 84 mg)

Inactive ingredients: hypromellose, magnesium stearate, microcrystalline cellulose, synthetic red iron oxide, titanium dioxide, triacetin

Other information

Blister: do not use if individual blister unit is open or torn
Bottle: do not use if printed foil under bottle cap is open or torn
store at 20°-25°C (68°-77°F)
avoid excessive heat or humidity
this product is sodium and sugar free

Zantac 75 Uses

relieves heartburn associated with acid indigestion and sour stomach
prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain foods and beverages

Zantac 75 Directions of Use

Adults and children 12 years and over:
- to relieve symptoms, swallow 1 tablet whole with a glass of water. The tablet must NOT be chewed or crushed.
- to prevent symptoms, swallow 1 tablet whole with a glass of water 30 to 60 minutes before eating food or drinking beverages that cause heartburn. The tablet must NOT be chewed or crushed.
- can be used up to twice daily (do not take more than 2 tablets in 24 hours)
Children under 12 years: ask a doctor

Zantac 75 can be taken 30 to 60 minutes before eating food or drinking beverages that cause heartburn to prevent symptoms, or it can be taken when heartburn symptoms strike, providing relief in as little as 30 minutes and lasting up to 12 hours.

You may take up to two (2) Zantac 75 tablets a day. Stop use and ask a doctor if you need to take this product for more than 14 days.

Zantac 75 Warnings

Allergy alert

Do NOT use if you are allergic to ranitidine or other acid reducers

Do NOT use:

if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor.
with other acid reducers

Ask a doctor before use if you have:

had heartburn over 3 months. This may be a sign of a more serious condition.
heartburn with lightheadedness, sweating or dizziness
chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness
frequent chest pain
frequent wheezing, particularly with heartburn
unexplained weight loss
nausea or vomiting
stomach pain

Stop use and ask a doctor if:

your heartburn continues or worsens
you need to take this product for more than 14 days

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

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

Maximum Strength Zantac 150

Active ingredient (in each tablet): Ranitidine 150 mg (as ranitidine hydrochloride 168 mg)

Inactive ingredients: hypromellose, magnesium stearate, microcrystalline cellulose, synthetic red iron oxide, titanium dioxide, triacetin

Other information

Blister: do not use if individual blister unit is open or torn
Bottle: do not use if printed foil under bottle cap is open or torn
store at 20°-25°C (68°-77°F)
avoid excessive heat or humidity
this product is sodium and sugar free

Maximum Strength Zantac 150 Uses

relieves heartburn associated with acid indigestion and sour stomach
prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain foods and beverages

Maximum Strength Zantac 150 Directions of Use

Adults and children 12 years and over:
- to relieve symptoms, swallow 1 tablet whole with a glass of water. The tablet must NOT be chewed or crushed.
- to prevent symptoms, swallow 1 tablet whole with a glass of water 30 to 60 minutes before eating food or drinking beverages that cause heartburn. The tablet must NOT be chewed or crushed.
- can be used up to twice daily (do not take more than 2 tablets in 24 hours)
Children under 12 years: ask a doctor

You may take up to two (2) Zantac 75 tablets a day. Stop use and ask a doctor if you need to take this product for more than 14 days.

Maximum Strength Zantac 150 Warnings

Allergy alert

Do NOT use if you are allergic to ranitidine or other acid reducers

Do NOT use:

if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor.
with other acid reducers

Ask a doctor before use if you have:

had heartburn over 3 months. This may be a sign of a more serious condition.
heartburn with lightheadedness, sweating or dizziness
chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness
frequent chest pain
frequent wheezing, particularly with heartburn
unexplained weight loss
nausea or vomiting
stomach pain

Stop use and ask a doctor if:

your heartburn continues or worsens
you need to take this product for more than 14 days

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

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

Zantac side effects

Most people who take Zantac (Ranitidine) do not have any side effects. If you do get a side effect, it is usually mild and will go away when you stop taking Zantac (Ranitidine).

The following side effects aren’t common and may happen in more than 1 in 1,000 people. Talk to your doctor or pharmacist if these side effects bother you or don’t go away:

stomach pains
constipation
feeling sick (nausea)
headache
diarrhea
vomiting

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

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

The following have been reported as events in clinical trials or in the routine management of patients treated with Zantac. The relationship to therapy with Zantac has been unclear in many cases. Headache, sometimes severe, seems to be related to administration of Zantac.

Central Nervous System

Rarely, malaise, dizziness, somnolence, insomnia, and vertigo. Rare cases of reversible mental confusion, agitation, depression, and hallucinations have been reported, predominantly in severely ill elderly patients. Rare cases of reversible blurred vision suggestive of a change in accommodation have been reported. Rare reports of reversible involuntary motor disturbances have been received.

Cardiovascular

As with other H2-blockers, rare reports of arrhythmias such as tachycardia, bradycardia, atrioventricular block, and premature ventricular beats.

Gastrointestinal

Constipation, diarrhea, nausea/vomiting, abdominal discomfort/pain, and rare reports of pancreatitis.

Hepatic

There have been occasional reports of hepatocellular, cholestatic, or mixed hepatitis, with or without jaundice. In such circumstances, Zantac (Ranitidine) should be immediately discontinued. These events are usually reversible, but in rare circumstances death has occurred. Rare cases of hepatic failure have also been reported. In normal volunteers, SGPT values were increased to at least twice the pretreatment levels in 6 of 12 subjects receiving 100 mg intravenously 4 times daily for 7 days, and in 4 of 24 subjects receiving 50 mg intravenously 4 times daily for 5 days.

Musculoskeletal

Rare reports of arthralgias and myalgias.

Hematologic

Blood count changes (leukopenia, granulocytopenia, and thrombocytopenia) have occurred in a few patients. These were usually reversible. Rare cases of agranulocytosis, pancytopenia, sometimes with marrow hypoplasia, and aplastic anemia and exceedingly rare cases of acquired immune hemolytic anemia have been reported.

Endocrine

Controlled studies in animals and man have shown no stimulation of any pituitary hormone by Zantac and no antiandrogenic activity, and cimetidine-induced gynecomastia and impotence in hypersecretory patients have resolved when Zantac has been substituted. However, occasional cases of impotence and loss of libido have been reported in male patients receiving Zantac, but the incidence did not differ from that in the general population. Rare cases of breast symptoms and conditions, including galactorrhea and gynecomastia, have been reported in both males and females.

Integumentary

Rash, including rare cases of erythema multiforme. Rare cases of alopecia and vasculitis.

Respiratory

A large epidemiological study suggested an increased risk of developing pneumonia in current users of histamine-2-receptor antagonists (H2RAs) compared with patients who had stopped H2RA treatment, with an observed adjusted relative risk of 1.63 (95% CI: 1.07–2.48). However, a causal relationship between use of H2RAs and pneumonia has not been established.

Other

Rare cases of hypersensitivity reactions (e.g., bronchospasm, fever, rash, eosinophilia), anaphylaxis, angioneurotic edema, acute interstitial nephritis, and small increases in serum creatinine.

Serious side effects

Serious side effects are very rare and happen in less than 1 in 10,000 people. Call a doctor straight away if you have:

stomach pain that seems to be getting worse – this can be a sign of an inflamed liver or pancreas
back pain, fever, pain when peeing or blood in your pee – these can be signs of kidney problems
a rash, swollen joints or kidney problems – these can be signs that your small blood vessels are swollen (vasculitis)
a slow or irregular heartbeat

Serious allergic reaction

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

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

The warning signs of a serious allergic reaction are:

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

How to cope with side effects

What to do about:

stomach pains – try to rest and relax. It can help to eat and drink slowly and have smaller and more frequent meals. Putting a heat pad or covered hot water bottle on your tummy may also help. If you are in a lot of pain, speak to your pharmacist or doctor.
constipation – eat more high-fiber foods such as fresh fruit and vegetables and cereals, and drink plenty of water. Try to exercise more regularly, for example, by going for a daily walk or run. If this doesn’t help, talk to your pharmacist or doctor.
feeling sick – it may help if you don’t eat rich or spicy food while you’re taking Zantac (Ranitidine).

Human Toxicity Reports

Headache (sometimes severe) occurs in approx 3% of patients receiving the drug ². Malaise, dizziness, somnolence, insomnia, and vertigo have been reported less frequently. Reversible mental confusion, agitation, mental depression, and hallucinations have occurred, mainly in debilitated geriatric patients. A child who was receiving prolonged, high-dose oral ranitidine therapy (8 mg/kg once daily for 10 months) developed altered consciousness, drowsiness, dysarthria, hyporeflexia, positive Babinski’s sign, diaphoresis, and bradycardia, which resolved within 24 hr after discontinuance of the drug.

Constipation, nausea, vomiting, and abdominal discomfort or pain have occurred in patients receiving ranitidine. Pancreatitis has been reported rarely ².

Rash, which may be urticarial, maculopapular, and/or pruritic, has been reported during ranitidine therapy ². Rash suggestive of mild erythema multiforme has occurred rarely. Urticaria at the site of injection has occurred following IV admin of ranitidine. Alopecia has occurred rarely ².

Leukopenia, granulocytopenia, agranulocytosis, thrombocytopenia, aplastic anemia, acquired immune hemolytic anemia, and pancytopenia, which may be accompanied by bone marrow hypoplasia, have been reported rarely in patients receiving ranitidine ². Alterations in blood cell counts usually were reversible. At least one case of leukocytosis has been reported 6-8 days after initiating ranitidine therapy, which resolved following discontinuance ². Aplastic anemia has occurred in at least one patient receiving ranitidine ².

Small increases in serum creatinine, without concomitant increases in BUN, have been reported during ranitidine therapy ². Increases in serum aminotransferase, alkaline phosphatase, LDH, total bilirubin, and gamma-glutamyl transferase concentration have been reported and reversible hepatitis, which may be hepatocellular, hepatocanalicular, or both and may or may not be accompanied by jaundice, has occurred occasionally in individuals receiving ranitidine and usually was reversible; however, death has been reported rarely ².

A 63 yr old woman developed anicteric hepatitis after two wk of therapy with ranitidine ³. Despite continuation of therapy, her symptoms resolved within 5 days and transaminase levels returned to normal in the next 4 weeks, at which time use of the drug ceased. No other cause for the reaction could be found ³.

Cardiac arrhythmias have occurred rarely in patients receiving ranitidine ². Bradycardia, sometimes assoc with dyspnea, has occurred ². Tachycardia, AV block, asystole, and ventricular premature complexes have also been reported rarely ².

Arthralgias, myalgias, and hypersensitivity reactions such as bronchospasm, fever, rash, and eosinophilia have occurred rarely in patients receiving ranitidine ². Anaphylaxis, characterized by severe urticaria and a decrease in blood pressure in one patient following administration of a single dose of ranitidine, has occurred rarely; exacerbation of asthma and angioedema also has occurred ². Mild erythema multiforme-like rash and alopecia also have occurred rarely. Rare reports suggest that ranitidine may precipitate acute attacks of porphyria in patients with acute porphyria; therefore, the drug should be avoided in patients with a history of acute porphyria ².

In a study of 51 male patients with duodenal ulcer, treatment with ranitidine, produced no decrease in basal levels of serum testosterone, as did cimetidine ⁴.

Ranitidine inhibited in a dose-dependent manner acetylcholinesterases from human erythrocytes and gastric mucosa ⁵. Pseudocholinesterase in serum was also inhibited, the levels required were about 25 times higher. A stimulation of cholinergic mechanisms in ranitidine treatment should occur, e.g, stimulation of glandular secretion or increase of gastrointestinal motility ⁵.

Symptoms of acute intoxication with both cimetidine and ranitidine are bradycardia and tachycardia ⁶; CNS disturbances, including confusion, delirium, drowsiness, slurred speech, flushing, and sweating; dermatologic lesions; endocrine abnormalities; GI disorders; and liver dysfunction ⁶.

Most controlled studies in humans indicate that ranitidine does not alter theophylline metabolism, even at high doses ⁷. However, there have been several case reports published recently which demonstrate the development of theophylline toxicity mostly in older patients receiving stable oral doses of this drug when ranitidine was administered simultaneously ⁷. A study involving eleven elderly (mean age, 69.0 + or – 6.2 years) patients with chronic obstructive pulmonary disease (COPD). During one week the patients took slow-release theophylline, 200 mg every 12 hr, followed by one week intake of the same dose of theophylline plus ranitidine tablets, 150 mg every 12 hr. At the end of each period, blood samples were obtained 0, 1, 2, 3, 4, 5, 6, 7, 8 and 12 hr after the morning dose for the determination of serum theophylline levels. The peak theophylline concentration (Tmax) was achieved after 4.1 + or – 0.9 hr while the patients were taking theophylline, and after 2.9 + or – 1.4 hr with the combined regimen. This difference was statistically significant. In only 3/11 subjects did Tmax remain unchanged during both phases of the study. The mean theophylline clearance rates while the patients were receiving theophylline alone (39.58 + or – 19.89 ml/min) and when they were receiving both medications 134.42 + or – 10.55 ml/min) were similar. The mean serum levels while the patients were receiving theophylline alone were slightly higher but not statistically different. These results suggest that the reported increases in serum theophylline levels in older patients receiving theophylline and ranitidine cannot be ascribed to slower theophylline metabolism in the geriatric patients with chronic obstructive pulmonary disease who is also given ranitidine ⁷.

A case report of acute cholestatic hepatitis associated with rash and hypereosinophilia, in which the absence of transfusion, intercurrent viral infection, alcohol consumption or other hepatotoxic drugs are suggestive of ranitidine-induced hepatotoxicity ⁸. The pathogenesis of the disorder is unknown, but the lack of a dose-effect relationship, the rarity and unpredictability of the reaction, as well as the clinical signs suggest that hypersensitivity is involved. Physicians should be aware of this rare and idiosyncratic side-effect of ranitidine ⁸.

Although acute interstitial nephritis has been well described with the histamine H2-receptor antagonist cimetidine, a study authors found only one previous case report of ranitidine-induced interstitial nephritis in the literature ⁹. They describe an additional patient who developed acute interstitial nephritis after taking ranitidine ⁹. Electron microscopy showed focal fusion of the epithelial cell foot processes that was not described in the previous report of ranitidine-induced interstitial nephritis.

Reversible hematologic abnormalities including hemolytic anemia ¹⁰ with a positive direct Coombs’ test have been associated with ranitidine. In addition to the case report cited above, the US Food and Drug Administration had received five other cases of hemolysis associated with recent intake of ranitidine as of February 1991 ¹⁰. To investigate the possible association of ranitidine with autoimmune hemolytic anemia, a study was conducted to determine how often diagnoses of hemolytic anemia or abnormal Coombs’ test results followed dispensing of ranitidine using the automated medical and pharmacy records of a large health maintenance organization. No occurrences of hemolytic anemia were identified among 12,054 individuals following 38,686 prescriptions for this medication. The 95% upper confidence bound was 3.1 cases/10,000 exposed persons. One abnormal direct Coombs test with mild anemia was discovered during routine prenatal testing of an asymptomatic patient who was dispensed ranitidine two and a half months previously. Hemolysis, however, was not demonstrated and an association with prior ranitidine use could not be confirmed. Additional analyses indicate that in only 30% of ranitidine courses was a blood count obtained. In those courses with hematocrits below 40%, less than 1% had a Coombs’ test performed. Chart review suggests that the majority of individuals with severe anemia have alternative explanations other than autoimmune hemolysis for their anemia ¹⁰. This analysis indicates that ranitidine is unlikely to be a common cause of clinically recognized autoimmune hemolytic anemia and demonstrates the utility of large automated medical and pharmacy data bases to conduct post-marketing studies of spontaneously reported drug effects.

Zantac overdose

Zantac (Ranitidine) overdose occurs when someone takes more than the normal or recommended amount of this medicine. This can be by accident or on purpose.

There has been limited experience with overdosage. Reported acute ingestions of up to 18 g orally have been associated with transient adverse effects similar to those encountered in normal clinical experience. In addition, abnormalities of gait and hypotension have been reported.

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

Symptoms of an Zantac (Ranitidine) overdose are:

Abnormal heartbeat, including rapid or slow heartbeat
Drowsiness, confusion
Diarrhea
Difficulty breathing
Dilated pupils
Flushing
Low blood pressure
Nausea, vomiting
Slurred speech
Sweating

Seek medical help right away. DO NOT make the person throw up unless poison control or a health care provider tells you to.

When overdosage occurs, the usual measures to remove unabsorbed material from the gastrointestinal tract, clinical monitoring, and supportive therapy should be employed.

Studies in dogs receiving dosages of Zantac in excess of 225 mg/kg/day have shown muscular tremors, vomiting, and rapid respiration. Single oral doses of 1,000 mg/kg in mice and rats were not lethal. Intravenous LD50 values in mice and rats were 77 and 83 mg/kg, respectively.

What to Expect at the Emergency Room

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

The provider will measure and monitor the person’s vital signs, including temperature, pulse, breathing rate, and blood pressure. Symptoms will be treated. The person may receive:

Activated charcoal
Blood and urine tests
Breathing support, including oxygen
Chest x-ray
ECG (electrocardiogram, or heart tracing)
Intravenous fluids (through a vein)
A laxative
Medicine to treat symptoms
Tube through the mouth into the stomach to empty the stomach (gastric lavage)

Outlook (Prognosis)

Serious complications are rare. These are generally safe medicines, even when taken in large doses.

McEvoy G.K. (ed.). American Hospital Formulary Service-Drug Information 96. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 1996 (Plus Supplements)., p. 2184[↩]
McEvoy G.K. (ed.). American Hospital Formulary Service-Drug Information 96. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 1996 (Plus Supplements)., p. 2182[↩][↩][↩][↩][↩][↩][↩][↩][↩][↩][↩][↩][↩][↩][↩]
Barr GD, Piper DW; Med J Aust 2 (8): 421; 1981 https://www.ncbi.nlm.nih.gov/pubmed/6275248[↩][↩]
Peden NR et al; Acta Endocrinol (Copenh) 96 (4): 564-8;1981 http://www.eje-online.org/content/96/4/564.long[↩]
Hansen WE, Bertl S; Z Gastroenterol 21 (4): 164-7;1983 https://www.ncbi.nlm.nih.gov/pubmed/6306938[↩][↩]
Haddad, L.M., Clinical Management of Poisoning and Drug Overdose. 2nd ed. Philadelphia, PA: W.B. Saunders Co., 1990., p. 824[↩][↩]
Cukier A et al; Braz J Med Biol Res 28 (8): 875-9;1995 https://www.ncbi.nlm.nih.gov/pubmed/8555989[↩][↩][↩]
Devuyst C et al; Acta Clin Belg 48 (2): 109-14;1993 https://www.ncbi.nlm.nih.gov/pubmed/8392242[↩][↩]
Gaughan WJ et al; Am J Kidney Dis 22 (2): 337-40;1993 https://www.ncbi.nlm.nih.gov/pubmed/8352263[↩][↩]
Choo PW et al; J Clin Epidemiol 47 (lO): 1175-9; 1994 ttps://www.ncbi.nlm.nih.gov/pubmed/7722551[↩][↩][↩]

Claritin

16.5K views

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.

How should Claritin be used?

Claritin (Loratadine) comes as a syrup (liquid), an immediate acting and extended release tablet, and a rapidly disintegrating (dissolving) tablet to take by mouth. It is usually taken once a day with or without food. Follow the directions on the package label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take Claritin (Loratadine) exactly as directed. Do not take more or less of it or take it more often than directed on the package label or recommended by your doctor. If you take more Claritin (Loratadine) than directed, you may experience drowsiness.

If you are taking the rapidly disintegrating tablet, follow the package directions to remove the tablet from the blister package without breaking the tablet. Do not try to push the tablet through the foil. After you remove the tablet from the blister package, immediately place it on your tongue and close your mouth. The tablet will quickly dissolve and can be swallowed with or without water.

Do not use Claritin (Loratadine) to treat hives that are bruised or blistered, that are an unusual color, or that do not itch. Call your doctor if you have this type of hives.

Stop taking Claritin (Loratadine) and call your doctor if your hives do not improve during the first 3 days of your treatment or if your hives last longer than 6 weeks. If you do not know the cause of your hives, call your doctor.

If you are taking Claritin (Loratadine) to treat hives, and you develop any of the following symptoms, get emergency medical help right away: difficulty swallowing, speaking, or breathing; swelling in and around the mouth or swelling of the tongue; wheezing; drooling; dizziness; or loss of consciousness. These may be symptoms of a life-threatening allergic reaction called anaphylaxis. If your doctor suspects that you may experience anaphylaxis with your hives, he may prescribe an epinephrine injector (EpiPen). Do not use Claritin (Loratadine) in place of the epinephrine injector.

Do not use this medication if the safety seal is open or torn.

Before taking Claritin – Precautions

tell your doctor and pharmacist if you are allergic to Claritin (Loratadine), any other medications, or any of the ingredients in the type of Claritin (Loratadine) you will be taking. Check the package label for a list of the ingredients.
tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements and herbal products you are taking or plan to take. Be sure to mention medications for colds and allergies.
tell your doctor if you have or have ever had asthma or kidney or liver disease.
tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking Claritin (Loratadine), call your doctor.
if you have phenylketonuria (PKU, an inherited condition in which a special diet must be followed to prevent mental retardation), you should know that some brands of the orally disintegrating tablets may contain aspartame that forms phenylalanine.

How and when to take Claritin

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

How much should I take?

Claritin (Loratadine) comes as 10mg tablets and as a liquid medicine (labelled either 5mg/ml or 1mg/1ml). You can take Claritin (Loratadine) with or without food.

The usual dose in adults is 10mg once a day.

Doses are usually lower for people with liver problems.

For children, your doctor will use your child’s weight or age to work out the right dose.

In studies with Claritin (Loratadine) tablets at doses 2 to 4 times higher than the recommended dose of 10 mg, a dose-related increase in the incidence of somnolence was observed. therefore, some patients, particularly those with hepatic or renal impairment and the elderly, may experience somnolence ⁸.

How to take it

Claritin (Loratadine) comes as 2 different types of tablet – ordinary and melt-in-the-mouth tablets.

Swallow ordinary Claritin (Loratadine) tablets with a drink of water, milk or juice. If the tablet has a score line, you can break it in half if you find it hard to swallow it whole. Do not chew it.

Melt-in-the-mouth tablets dissolve instantly on your tongue without needing a drink. Be careful not to crush them when you take them out of the packet.

Claritin (Loratadine) liquid may be easier for children to take than tablets. The medicine will come with a plastic syringe or spoon to help you measure out the right dose. If you don’t have a syringe or spoon, ask your pharmacist for one. Do not use a kitchen teaspoon as it will not give the right amount.

Claritin (Loratadine) tablets and melt-in-the-mouth tablets must only be taken by children aged between 2 and 12 years if they weigh 30kg or more. Give children Claritin (Loratadine) liquid if they weigh less than 30kg.

When to take it

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

What should I do if I forget a dose?

Take your forgotten dose as soon as you remember, unless it is nearly time for your next dose. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a forgotten dose.

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

What if I take too much?

Claritin (Loratadine) is generally very safe. Taking too much is unlikely to harm you or your child.

If you take an extra dose by mistake, you might get a headache, have a rapid heartbeat or feel sleepy. If this happens or you’re concerned, contact your doctor.

Claritin dosage

Claritin RediTabs 12-Hour

Active ingredient (in each tablet): Loratadine 5 mg (Antihistamine)

Inactive Ingredients: Anhydrous citric acid, gelatin, mannitol, mint flavor

Claritin RediTabs 12-Hour – WARNINGS

Do not use if you have ever had an allergic reaction to this product or any of its ingredients
Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.
When using this product do not take more than directed. Taking more than directed may cause drowsiness.
Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Claritin RediTabs 12-Hour Uses

Temporarily relieves:
- Runny Nose
- Sneezing
- Itchy, Watery Eyes
- Itchy Nose or Throat

Directions of use:

Place 1 tablet on tongue; tablet disintegrates, with or without water.

Table 1. Claritin RediTabs 12-Hour Dosage Chart

Adults and children 6 years and over	1 tablet every 12 hours; not more than 2 tablets in 24 hours
Children under 6 years of age	Ask a doctor
Consumers with liver or kidney disease	Ask a doctor

Other information:

Safety sealed. Do not use if the individual blister unit imprinted with Claritin® RediTabs® is open or torn.
Store between 20° to 25°C (68° to 77°F)
Use tablet immediately after opening individual blister.
Complies with USP Procedure 2 for Assay and Organic Impurities and Test 2 for Disintegration.

Claritin Tablets 24-Hour

Active ingredient (in each tablet): Loratadine 10 mg (Antihistamine)

Inactive Ingredients: Corn starch, lactose monohydrate, magnesium stearate

Claritin Tablets 24-Hour – WARNINGS

Do not use if you have ever had an allergic reaction to this product or any of its ingredients
Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.
When using this product do not take more than directed. Taking more than directed may cause drowsiness.
Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Claritin Tablets 24-Hour Uses

Temporarily relieves:
- Runny Nose
- Sneezing
- Itchy, Watery Eyes
- Itchy Nose or Throat

Directions of use:

Table 2. Claritin Tablets 24-Hour Dosage Chart

Adults and children 6 years and over	1 tablet daily; not more than 1 tablet in 24 hours
Children under 6 years of age	Ask a doctor
Consumers with liver or kidney disease	Ask a doctor

Other information:

Safety sealed. Do not use if the individual blister unit imprinted with Claritin is open or torn (applies to blisters).
Tamper-evident: do not use if foil seal under cap, printed with “SEALED for YOUR PROTECTION” is missing, open, or broken (applies to bottles).
Store between 20° to 25°C (68° to 77°F)
Protect from excessive moisture

Claritin RediTabs 24-Hour

Active ingredient (in each tablet): Loratadine 10 mg (Antihistamine)

Inactive Ingredients: Anhydrous citric acid, gelatin, mannitol, mint flavor

Claritin RediTabs 24-Hour – WARNINGS

Do not use if you have ever had an allergic reaction to this product or any of its ingredients
Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.
When using this product do not take more than directed. Taking more than directed may cause drowsiness.
Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Claritin RediTabs 24-Hour Uses

Temporarily relieves:
- Runny Nose
- Sneezing
- Itchy, Watery Eyes
- Itchy Nose or Throat

Directions of use:

Place 1 tablet on tongue; tablet disintegrates, with or without water.

Table 3. Claritin RediTabs 24-Hour Dosage Chart

Adults and children 6 years and over	1 tablet daily; not more than 1 tablet in 24 hours
Children under 6 years of age	Ask a doctor
Consumers with liver or kidney disease	Ask a doctor

Other information:

Safety sealed. Do not use if the individual blister unit imprinted with Claritin® RediTabs® is open or torn.
Store between 20° to 25°C (68° to 77°F)
Use tablet immediately after opening individual blister.
Complies with USP Procedure 2 for Assay and Organic Impurities and Test 2 for Disintegration.

Claritin Liqui-Gels Capsules 24-Hour

Active ingredient (in each tablet): Loratadine 10 mg (Antihistamine)

Inactive Ingredients: Caprylic/capric glycerides, FD&C blue no.1, gelatin, glycerin, pharmaceutical ink, polysorbate 80, povidone, purified water, sorbitol

Claritin Liqui-Gels Capsules 24-Hour – WARNINGS

Do not use if you have ever had an allergic reaction to this product or any of its ingredients
Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.
When using this product do not take more than directed. Taking more than directed may cause drowsiness.
Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Safety sealed. Do not use if the individual blister unit imprinted with Claritin® Liqui-Gels® is open or torn.

Claritin Liqui-Gels Capsules 24-Hour Uses

Temporarily relieves:
- Runny Nose
- Sneezing
- Itchy, Watery Eyes
- Itchy Nose or Throat

Directions of use:

Table 4. Claritin Liqui-Gels Capsules 24-Hour Dosage Chart

Adults and children 6 years and over	1 capsule daily; not more than 1 capsule in 24 hours
Children under 6 years of age	Ask a doctor
Consumers with liver or kidney disease	Ask a doctor

Other information:

Safety sealed. Do not use if the individual blister unit imprinted with Claritin® Liqui-Gels® is open or torn.
Store between 20° to 25°C (68° to 77°F)
Protect from freezing

Children’s Claritin Syrup 24-Hour

Active ingredient (in each tablet): Loratadine 5 mg in each 5mL teaspoonful (Antihistamine)

Inactive Ingredients: Edetate disodium, flavor, glycerin, maltitol, monobasic sodium phosphate, phosphoric acid, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose

Children’s Claritin Syrup 24-Hour – WARNINGS

Do not use if you have ever had an allergic reaction to this product or any of its ingredients
Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.
When using this product do not take more than directed. Taking more than directed may cause drowsiness.
Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Children’s Claritin Syrup 24-Hour Uses

Temporarily relieves:
- Runny Nose
- Sneezing
- Itchy, Watery Eyes
- Itchy Nose or Throat

Directions of use:

Use only with enclosed dosing cup.

Table 5. Children’s Claritin Syrup 24-Hour Dosage Chart

Adults and children 6 years and over	2 teaspoonfuls (tsp) daily; do not take more than 2 teaspoonfuls (tsp) in 24 hours
Children 2 to under 6 years of age	1 teaspoonful (tsp) daily; do not take more than 1 teaspoonful (tsp) in 24 hours
Children under 2 years of age	Ask a doctor
Consumers with liver or kidney disease	Ask a doctor

Other information:

Each teaspoon contains: sodium 5 mg
Do not use if tape imprinted with “SEALED FOR YOUR PROTECTION” on tap and bottom flaps of carton is not intact
Store between 20° to 25°C (68° to 77°F)

Claritin side effects

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

Reported adverse events with an incidence of more than 2% in Loratadine, 10 mg/daily versus placebo-controlled allergic rhinitis clinical trials percent of patients reporting: Headache (12%), Somnolence (8%), Fatigue (4%), Dry Mouth (3%) ⁹.

Common side effects

The most common side effect of Claritin (Loratadine) is feeling sleepy. This happens in more than 1 in 100 people.

Children may also have a headache, feel tired or feel nervous. Talk to your doctor or pharmacist if these side effects bother you or don’t go away.

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

headache
dry mouth
nosebleed
sore throat
mouth sores
difficulty falling asleep or staying asleep
nervousness
weakness
stomach pain
diarrhea
red or itchy eyes

The following adverse events have been reported in 2% or fewer patients ⁹:

Autonomic Nervous System

Altered lacrimation, altered salivation, flushing, hypesthesia, impotence, increased sweating, thirst.

Body As a Whole

Angioneurotic edema, asthenia, back pain, blurred vision, chest pain, conjunctivitis, earache, eye pain, fever, leg cramps, malaise, rigors, tinnitus, upper respiratory infection, weight gain.

Cardiovascular System

Hypertension, hypotension, palpitations, syncope, tachycardia.

Central and Peripheral Nervous System

Blepharospasm, dizziness, dysphonia, hyperkinesia, migraine, paresthesia, tremor, vertigo.

Gastrointestinal System

Abdominal distress, altered taste, anorexia, constipation, diarrhea, dyspepsia, flatulence, gastritis, increased appetite, nausea, stomatitis, toothache, vomiting.

Musculoskeletal System

Arthralgia, myalgia. Psychiatric: Agitation, amnesia, anxiety, confusion, decreased libido, depression, impaired concentration, insomnia, nervousness, paroniria.

Reproductive System

Breast pain, dysmenorrhea, menorrhagia, vaginitis.

Respiratory System

Bronchitis, bronchospasm, coughing, dyspnea, epistaxis, hemoptysis, laryngitis, nasal congestion, nasal dryness, pharyngitis, sinusitis, sneezing.

Skin and Appendages

Dermatitis, dry hair, dry skin, photosensitivity reaction, pruritus, purpura, rash, urticaria.

Urinary System

Altered micturition, urinary discoloration.

Some side effects may be serious.

Serious side effects

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

If you experience any of the following symptoms, stop taking Claritin (Loratadine) and call your doctor immediately:

rash
hives
itching
swelling of the eyes, face, lips, tongue, throat, hands, arms, feet, ankles, or lower legs
hoarseness
difficulty breathing or swallowing
wheezing

In rare cases, Claritin (Loratadine) may cause a serious allergic reaction.

The warning signs of a serious allergic reaction are:

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

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

How to cope with side effects

What to do about:

feeling sleepy – try a different non-drowsy antihistamine. If this doesn’t help, talk to your doctor.

Human Toxicity Reports

Somnolence, tachycardia, and headache have been reported with overdoses greater than 10 mg (40 to 180 mg) ¹⁰.

Use of antihistamines is not recommended in newborn or premature infants because this age group has an increased susceptibility to anticholinergic side effects, such as central nervous system (CNS) excitation, and an increased tendency toward convulsions ¹¹. A paradoxical reaction characterized by hyperexcitability may occur in children taking antihistamines ¹¹.

Dizziness, sedation, confusion, and hypotension may be more likely to occur in geriatric patients taking antihistamines ¹¹. A paradoxical reaction characterized by hyperexcitability may occur in geriatric patients taking antihistamines. Geriatric patients are especially susceptible to the anticholinergic side effects, such as dryness of mouth and urinary retention (especially in males), of the antihistamines. If these side effects occur and continue or are severe, medication should probably be discontinued.

Claritin overdose

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

Symptoms of Claritin (Loratadine) overdose may include:

fast or pounding heartbeat
drowsiness
headache
unusual body movements

Bruttmann G, et al; J Allergy Clin Immunol 83 (2 Pt 1): 411-16; 1989 https://www.ncbi.nlm.nih.gov/pubmed/2563743[↩]
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[↩][↩]
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[↩][↩]
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.[↩][↩]
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[↩][↩]
Merlob P. Prospective follow-up of adverse reactions in breast-fed infants exposed to maternal loratadine treatment; 1999-2002[↩][↩]
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[↩]
PDR; Physicians’ Desk Reference. 50th Ed. Montvale, NJ: Medical Economics Co. p.2349; 1996[↩]
PDR; Physicians’ Desk Reference. 50th Ed. Montvale, NJ: Medical Economics Co. p.2350;1996[↩][↩]
PDR; Physicians’ Desk Reference. 50th Ed. Montvale, NJ: Medical Economics Co. p.2350; 1996[↩]
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[↩][↩][↩]

Advil

9.28K views

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.

IMPORTANT WARNING

People who take nonsteroidal anti-inflammatory drugs (NSAIDs) (other than aspirin) such as ibuprofen may have a higher risk of having a heart attack or a stroke than people who do not take these medications. These events may happen without warning and may cause death. This risk may be higher for people who take NSAIDs for a long time. Do not take an NSAID such as ibuprofen if you have recently had a heart attack, unless directed to do so by your doctor. Tell your doctor if you or anyone in your family has or has ever had heart disease, a heart attack, or a stroke; if you smoke; and if you have or have ever had high cholesterol, high blood pressure, or diabetes. Get emergency medical help right away if you experience any of the following symptoms: chest pain, shortness of breath, weakness in one part or side of the body, or slurred speech.

If you will be undergoing a coronary artery bypass graft (CABG; a type of heart surgery), you should not take ibuprofen right before or right after the surgery.

NSAIDs such as ibuprofen may cause ulcers, bleeding, or holes in the stomach or intestine. These problems may develop at any time during treatment, may happen without warning symptoms, and may cause death. The risk may be higher for people who take NSAIDs for a long time, are older in age, have poor health, or who drink three or more alcoholic drinks per day while taking ibuprofen. Tell your doctor if you take any of the following medications: anticoagulants (‘blood thinners’) such as warfarin (Coumadin, Jantoven); aspirin; other NSAIDs such as ketoprofen and naproxen (Aleve, Naprosyn); oral steroids such as dexamethasone, methylprednisolone (Medrol), and prednisone (Rayos); selective serotonin reuptake inhibitors (SSRIs) such as citalopram (Celexa), fluoxetine (Prozac, Sarafem, Selfemra, in Symbyax), fluvoxamine (Luvox), paroxetine (Brisdelle, Paxil, Pexeva), and sertraline (Zoloft); or serotonin norepinephrine reuptake inhibitors (SNRIs) such as desvenlafaxine (Khedezla, Pristiq), duloxetine (Cymbalta), and venlafaxine (Effexor XR). Also tell your doctor if you have or have ever had ulcers, bleeding in your stomach or intestines, or other bleeding disorders. If you experience any of the following symptoms, stop taking ibuprofen and call your doctor: stomach pain, heartburn, vomit that is bloody or looks like coffee grounds, blood in the stool, or black and tarry stools.

Keep all appointments with your doctor and the laboratory. Your doctor will monitor your symptoms carefully and will probably order certain tests to check your body’s response to ibuprofen. Be sure to tell your doctor how you are feeling so that your doctor can prescribe the right amount of medication to treat your condition with the lowest risk of serious side effects.

Your doctor or pharmacist will give you the manufacturer’s patient information sheet (Medication Guide) when you begin treatment with prescription ibuprofen and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (https://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer’s website to obtain the Medication Guide.

Advil vs Ibuprofen

Advil is a medicine that contains a nonsteroidal anti-inflammatory drug (NSAID) – Ibuprofen.

Who can and can’t take Advil

Some brands of Advil (ibuprofen) tablets, capsules and syrup contain aspartame, colors (E numbers), gelatin, glucose, lactose, sodium, sorbitol, soya or sucrose, so they may be unsuitable for some people.

Don’t take Advil (ibuprofen) by mouth if you:

have had an allergic reaction to Advil (ibuprofen) or any other medicines in the past
have previously had a reaction, such as asthma, a raised, itchy red rash (urticaria), swelling underneath your skin (angioedema) or swelling of the inside of your nose (rhinitis)
have taken aspirin or any other nonsteroidal anti-inflammatory drug (NSAID)
have asthma or another allergic illness
are trying to get pregnant, are already pregnant or if you’re breastfeeding

To make sure Advil (ibuprofen) (by mouth) is safe for you, tell your doctor or pharmacist if you have:

had bleeding in your stomach, a stomach ulcer, or a perforation (a hole) in your stomach
a health problem that means you have an increased chance of bleeding
liver problems, such as liver fibrosis, cirrhosis or liver failure
heart disease or severe heart failure
kidney failure
Crohn’s disease or ulcerative colitis
chickenpox or shingles – taking Advil (ibuprofen) can increase the chance of certain infections and skin reactions

Cautions with other medicines

Advil (ibuprofen) doesn’t mix well with some medicines.

Advil (ibuprofen) applied to the skin is less likely to interfere with other medicines than if it’s taken by mouth.

For safety, tell your doctor if you’re taking these medicines before you start taking Advil (ibuprofen) by mouth or on your skin:

blood-thinning medicines such as warfarin
anti-inflammatory painkillers such as aspirin, diclofenac, mefenamic acid and naproxen
medicines for high blood pressure
steroid medicines such as betamethasone, dexamethasone, hydrocortisone or prednisolone
antibiotics such as ciprofloxacin, levofloxacin, moxifloxacin, nalidixic acid, norfloxacin or ofloxacin
antidepressants such as citalopram, fluoxetine, fluvoxamine, venlafaxine, paroxetine or sertraline
diabetes medicines such as gliclazide, glimepiride, glipizide and tolbutamide

How should Advil be used?

Prescription Advil (ibuprofen) comes as a tablet to take by mouth. It is usually taken three or four times a day for arthritis or every 4 to 6 hours as needed for pain. Nonprescription Advil (ibuprofen) comes as a tablet, chewable tablet, suspension (liquid), and drops (concentrated liquid). Adults and children older than 12 years of age may usually take nonprescription Advil (ibuprofen) every 4 to 6 hours as needed for pain or fever. Children and infants may usually be given nonprescription Advil (ibuprofen) every 6 to 8 hours as needed for pain or fever, but should not be given more than 4 doses in 24 hours. Advil (ibuprofen) may be taken with food or milk to prevent stomach upset. If you are taking Advil (ibuprofen) on a regular basis, you should take it at the same time(s) every day. Follow the directions on the package or prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take Advil (ibuprofen) exactly as directed. Do not take more or less of it or take it more often than directed by the package label or prescribed by your doctor.

Advil (ibuprofen) comes alone and in combination with other medications. Some of these combination products are available by prescription only, and some of these combination products are available without a prescription and are used to treat cough and cold symptoms and other conditions. If your doctor has prescribed a medication that contains Advil (ibuprofen), you should be careful not to take any nonprescription medications that also contain Advil (ibuprofen).

If you are selecting a product to treat cough or cold symptoms, ask your doctor or pharmacist for advice on which product is best for you. Check nonprescription product labels carefully before using two or more products at the same time. These products may contain the same active ingredient(s) and taking them together could cause you to receive an overdose. This is especially important if you will be giving cough and cold medications to a child.

Nonprescription cough and cold combination products, including products that contain Advil (ibuprofen), can cause serious side effects or death in young children. Do not give these products to children younger than 4 years of age. If you give these products to children 4 to 11 years of age, use caution and follow the package directions carefully.

If you are giving Advil (ibuprofen) or a combination product that contains Advil (ibuprofen) to a child, read the package label carefully to be sure that it is the right product for a child of that age. Do not give Advil (ibuprofen) products that are made for adults to children.

Before you give an Advil (ibuprofen) product to a child, check the package label to find out how much medication the child should receive. Give the dose that matches the child’s age on the chart. Ask the child’s doctor if you don’t know how much medication to give the child.

Shake the suspension and drops well before each use to mix the medication evenly. Use the measuring cup provided to measure each dose of the suspension, and use the dosing device provided to measure each dose of the drops.

The chewable tablets may cause a burning feeling in the mouth or throat. Take the chewable tablets with food or water.

Stop taking nonprescription Advil (ibuprofen) and call your doctor if your symptoms get worse, you develop new or unexpected symptoms, the part of your body that was painful becomes red or swollen, your pain lasts for more than 10 days, or your fever lasts more than 3 days. Stop giving nonprescription Advil (ibuprofen) to your child and call your child’s doctor if your child does not start to feel better during the first 24 hours of treatment. Also stop giving nonprescription Advil (ibuprofen) to your child and call your child’s doctor if your child develops new symptoms, including redness or swelling on the painful part of his body, or if your child’s pain or fever get worse or lasts longer than 3 days.

Do not give nonprescription Advil (ibuprofen) to a child who has a sore throat that is severe or does not go away, or that comes along with fever, headache, nausea, or vomiting. Call the child’s doctor right away, because these symptoms may be signs of a more serious condition.

Other uses for Advil

Advil (ibuprofen) is also sometimes used to treat ankylosing spondylitis (arthritis that mainly affects the spine), gouty arthritis (joint pain caused by a build-up of certain substances in the joints), and psoriatic arthritis (arthritis that occurs with a long-lasting skin disease that causes scaling and swelling). Talk to your doctor about the risks of using this drug for your condition.

This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking Advil

tell your doctor and pharmacist if you are allergic to Advil (ibuprofen), aspirin or other NSAIDs such as ketoprofen and naproxen (Aleve, Naprosyn), any other medications, or any of the inactive ingredients in the type of Advil (ibuprofen) you plan to take. Ask your pharmacist or check the label on the package for a list of the inactive ingredients.
tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention the medications listed in the IMPORTANT WARNING section and any of the following: angiotensin-converting enzyme (ACE) inhibitors such as benazepril (Lotensin, in Lotrel), captopril, enalapril (Vasotec, in Vaseretic), fosinopril, lisinopril (in Zestoretic), moexipril (Univasc), perindopril (Aceon, in Prestalia), quinapril (Accupril, in Quinaretic), ramipril (Altace), and trandolapril (Mavik, in Tarka); angiotensin receptor blockers such as candesartan (Atacand, in Atacand HCT), eprosartan (Teveten), irbesartan (Avapro, in Avalide), losartan (Cozaar, in Hyzaar), olmesartan (Benicar, in Azor, in Benicar HCT, in Tribenzor), telmisartan (Micardis, in Micardis HCT, in Twynsta), and valsartan (in Exforge HCT); beta blockers such as atenolol (Tenormin, in Tenoretic), labetalol (Trandate), metoprolol (Lopressor, Toprol XL, in Dutoprol), nadolol (Corgard, in Corzide), and propranolol (Hemangeol, Inderal, Innopran); diuretics (‘water pills’); lithium (Lithobid); and methotrexate (Otrexup, Rasuvo, Trexall). Your doctor may need to change the doses of your medications or monitor you more carefully for side effects.
do not take nonprescription Advil (ibuprofen) with any other medication for pain unless your doctor tells you that you should.
tell your doctor if you have or have ever had any of the conditions mentioned in the IMPORTANT WARNING section or asthma, especially if you also have frequent stuffed or runny nose or nasal polyps (swelling of the inside of the nose); heart failure; swelling of the hands, arms, feet, ankles, or lower legs; lupus (a condition in which the body attacks many of its own tissues and organs, often including the skin, joints, blood, and kidneys); or liver or kidney disease. If you are giving Advil (ibuprofen) to a child, tell the child’s doctor if the child has not been drinking fluids or has lost a large amount of fluid from repeated vomiting or diarrhea.
tell your doctor if you are pregnant, especially if you are in the last few months of your pregnancy; you plan to become pregnant; or you are breast-feeding. If you become pregnant while taking Advil (ibuprofen), call your doctor.
if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking Advil (ibuprofen).
if you have phenylketonuria (PKU, an inborn disease in which mental retardation develops if a specific diet is not followed), read the package label carefully before taking nonprescription Advil (ibuprofen). Some types of nonprescription Advil (ibuprofen) may be sweetened with aspartame, a source of phenylalanine.

Advil dosage

A few reminders:

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

How many Advil can I take?

The usual dose for adults is one or two 200mg tablets 3 times a day. If this isn’t enough, your doctor may prescribe a higher dose of up to 600mg to take 4 times a day.

If you take Advil (ibuprofen) 3 times a day, leave at least 6 hours between doses. If you take it 4 times a day, leave at least 4 hours between doses.

If you have pain all the time, your doctor may recommend slow-release Advil (ibuprofen) tablets or capsules. It’s usual to take these once a day in the evening or twice a day. Leave a gap of 10 to 12 hours between doses if you’re taking Advil (ibuprofen) twice a day.

For people who find it difficult to swallow tablets or capsules, Advil (ibuprofen) is available as a tablet that melts in your mouth, granules that you mix with a glass of water to make a drink, and as a syrup.

Swallow Advil (ibuprofen) tablets or capsules whole with a glass of water or milk. Don’t chew, break, crush or suck them as this could irritate your mouth or throat.

Always take Advil (ibuprofen) tablets and capsules after a meal or snack or with a drink of milk. It will be less likely to upset your tummy.

What if I forget to take it?

Take the missed dose as soon as you remember, unless it’s almost time for your next dose. In this case, skip the missed dose and take your next dose as normal.

Never take a double dose to make up for a forgotten one.

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

What if I take too much?

Taking too much Advil (ibuprofen) by mouth can be dangerous. It can cause side effects such as:

feeling sick and vomiting
tummy pain
feeling tired or sleepy
black poo and blood in your vomit – a sign of bleeding in your stomach
tinnitus (ringing in your ears)
difficulty breathing or changes in your heart rate (slower or faster)

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

Advil Tablets

Active Ingredient: Ibuprofen 200 mg in each tablet / caplets / gel caplets

Inactive Ingredients: acetylated monoglycerides, colloidal silicon dioxide, corn starch, croscarmellose sodium, methylparaben, microcrystalline cellulose, pharmaceutical glaze, pharmaceutical ink, povidone, pregelatinized starch, propylparaben, sodium benzoate, sodium lauryl sulfate, stearic acid, sucrose, synthetic iron oxide, titanium dioxide, white wax

Other information:

read all warnings and directions before use. Keep carton.
store at 20-25 °C (68-77 °F)
avoid excessive heat above 40 °C (104 °F)

Advil Uses

Temporarily relieves minor aches and pains due to:
- Headache
- Toothache
- Backache
- Menstrual cramps
- The common cold
- Muscular aches
- Minor pain of arthritis
Temporarily reduces fever

Dosing Information:

The smallest effective dose should be used

12 years of age and older:
- 1 tablet/caplet/gel caplet every 4 to 6 hours while symptoms persist.
- If pain or fever does not respond to 1 tablet/caplet/gel caplet, 2 may be used.
- Do not exceed 6 tablets/caplets/gel caplets in 24 hours unless directed by a doctor.
Under 12 years of age: Ask a doctor.

Advil Warnings

Allergy alert

Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

hives
facial
swelling
asthma (wheezing)
shock
skin reddening
rash
blisters

If an allergic reaction occurs, stop use and seek medical help right away.

Stomach bleeding warning

This product contains an nonsteroidal anti-inflammatory drug (NSAID), which may cause severe stomach bleeding. The chance is higher if you:

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

Heart attack and stroke warning

Nonsteroidal anti-inflammatory drugs (NSAIDs), except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed

Do NOT use

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

Ask a doctor before use if:

stomach bleeding warning applies to you
you have problems or serious side effects from taking pain relievers or fever reducers
you have a history of stomach problems, such as heartburn
you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke
you are taking a diuretic

Ask a doctor or pharmacist before use if you are:

under a doctor’s care for any serious condition
taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
taking any other drug

Stop use and ask a doctor if:

you experiences any of the following signs of stomach bleeding:
- feel faint
- vomits blood
- has bloody or black stools
- has stomach pain that does not get better
you have symptoms of heart problems or stroke:
- chest pain
- trouble breathing
- weakness in one part or side of body
- slurred speech
- leg swelling
you do not get any relief within first day (24 hours) of treatment
pain gets worse or lasts more than 10 days
fever gets worse or lasts more than 3 days
redness or swelling is present in the painful area
any new symptoms appear

Infants’ Advil Drops

Active Ingredient: Ibuprofen 50 mg in each 1.25mL

Inactive Ingredients: acetic acid, artificial flavor, butylated hydroxytoluene, carboxymethylcellulose sodium, citric acid monohydrate, edetate disodium, glycerin, microcrystalline cellulose, polysorbate 80, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucrose, xanthan gum

Infants’ Advil Drops Uses

Temporarily reduces fever
Temporarily relieves minor aches and pains due to the common cold, flu, headaches and toothaches

Dosing Information:

Shake well before using
Repeat dose every 6-8 hours, if needed
Do not use more than 4 times a day
Find right dose on chart below. If possible, use weight to dose; otherwise use age.
Only use the measuring device that comes with the product to be sure you give the right dose.
When using this product take with food or milk if stomach upset occurs.

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

Table 1. Infants’ Advil Drops Dosage

Weight (lb)	Age (months)	Dose (mL)
	Under 6 months	Ask a Doctor
12-17 lb	6-11 months	1.25 mL
18-23 lb	12-23 months	1.875 mL

Other information:

one dose lasts 6-8 hours
store at 20-25°C (68-77°F)
see bottom of box for lot number and expiration date

Infants’ Advil Drops Warnings

Allergy alert

Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

hives
facial
swelling
asthma (wheezing)
shock
skin reddening
rash
blisters

If an allergic reaction occurs, stop use and seek medical help right away.

Stomach bleeding warning

This product contains an nonsteroidal anti-inflammatory drug (NSAID), which may cause severe stomach bleeding. The chance is higher if the child:

has had stomach ulcers or bleeding problems
takes a blood thinning (anticoagulant) or steroid drug
takes other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
takes more or for a longer time than directed

Heart attack and stroke warning

Do NOT use

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

Ask a doctor before use if:

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

Ask a doctor or pharmacist before use if the child is:

under a doctor’s care for any serious condition
taking any other drug

Stop use and ask a doctor if:

child experiences any of the following signs of stomach bleeding:
- feel faint
- vomits blood
- has bloody or black stools
- has stomach pain that does not get better
child has symptoms of heart problems or stroke:
- chest pain
- trouble breathing
- weakness in one part or side of body
- slurred speech
- leg swelling
child does not get any relief within first day (24 hours) of treatment
fever or pain gets worse or lasts more than 3 days
redness or swelling is present in the painful area
any new symptoms appear

Children’s Advil Suspension

Active Ingredient: Ibuprofen 100 mg in each 5mL

Inactive Ingredients: artificial flavor, carboxymethylcellulose sodium, citric acid monohydrate, edetate disodium, glycerin, microcrystalline cellulose, polysorbate 80, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose, xanthan gum

FRUIT FLAVOR: artificial flavor, carboxymethylcellulose sodium, citric acid monohydrate, edetate disodium, FD&C red no. 40, glycerin, microcrystalline cellulose, polysorbate 80, purified water, sodium benzoate, sorbitol solution, sucrose, xanthan gum
GRAPE: acetic acid, artificial flavor, butylated hydroxytoluene, carboxymethylcellulose sodium, citric acid monohydrate, edetate disodium, FD&C blue no.1, FD&C red no. 40, glycerin, microcrystalline cellulose, polysorbate 80, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucrose, xanthan gum
WHITE GRAPE: acetic acid, artificial flavor, butylated hydroxytoluene, carboxymethylcellulose sodium, citric acid monohydrate, edetate disodium, glycerin, microcrystalline cellulose, polysorbate 80, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucrose, xanthan gum
BLUE RASPBERRY: artificial and natural flavors, carboxymethylcellulose sodium, citric acid monohydrate, edetate disodium, FD&C blue no. 1, glycerin, microcrystalline cellulose, polysorbate 80, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucrose, xanthan gum

Children’s Advil Suspension Uses

Temporarily reduces fever
Temporarily relieves minor aches and pains due to the common cold, flu, headaches and toothaches

Dosing Information:

Shake well before using
Repeat dose every 6-8 hours, if needed
Do not use more than 4 times a day
Find right dose on chart below. If possible, use weight to dose; otherwise use age.
Only use the measuring device that comes with the product to be sure you give the right dose.
When using this product take with food or milk if stomach upset occurs.

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

Table 2. Children’s Advil Suspension Dosage

Weight (lb)	Age (yrs)	Dose (tsp)
Under 24 lb	Under 2 Year	Ask a Doctor
24 – 35 lb	2 – 3 yr	1 tsp
36- 47 lb	4 – 5 yr	1 ½ tsp
48 – 59 lb	6 – 8 yr	2 tsp
60 – 71 lb	9 – 10 yr	2 ½ tsp
72 – 95 lb	11 yr	3 tsp

Other information:

each 5 mL contains: sodium 3 mg (Grape, White Grape, Fruit, and Bubblegum)
each 5 mL contains: sodium 10 mg (Blue Raspberry and Sugar Free/Dye Free Berry)
one dose lasts 6-8 hours
store at 20-25°C (68-77°F)
see bottom of box for lot number and expiration date

Children’s Advil Suspension Warnings

Allergy alert

Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

hives
facial
swelling
asthma (wheezing)
shock
skin reddening
rash
blisters

If an allergic reaction occurs, stop use and seek medical help right away.

Stomach bleeding warning

This product contains an nonsteroidal anti-inflammatory drug (NSAID), which may cause severe stomach bleeding. The chance is higher if the child:

has had stomach ulcers or bleeding problems
takes a blood thinning (anticoagulant) or steroid drug
takes other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
takes more or for a longer time than directed

Heart attack and stroke warning

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

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.

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

Aleve

8.63K views

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).

IMPORTANT WARNING

People who take nonsteroidal anti-inflammatory drugs (NSAIDs) (other than aspirin) such as naproxen may have a higher risk of having a heart attack or a stroke than people who do not take these medications. These events may happen without warning and may cause death. This risk may be higher for people who take NSAIDs for a long time. Do not take an NSAID such as naproxen if you have recently had a heart attack, unless directed to do so by your doctor. Tell your doctor if you or anyone in your family has or has ever had heart disease, a heart attack, or a stroke, if you smoke, and if you have or have ever had high cholesterol, high blood pressure, or diabetes. Get emergency medical help right away if you experience any of the following symptoms: chest pain, shortness of breath, weakness in one part or side of the body, or slurred speech.

If you will be undergoing a coronary artery bypass graft (CABG; a type of heart surgery), you should not take naproxen right before or right after the surgery.

NSAIDs such as naproxen may cause ulcers, bleeding, or holes in the stomach or intestine. These problems may develop at any time during treatment, may happen without warning symptoms, and may cause death. The risk may be higher for people who take NSAIDs for a long time, are older in age, have poor health, or who drink three or more alcoholic drinks per day while taking naproxen. Tell your doctor if you take any of the following medications: anticoagulants (”blood thinners”) such as warfarin (Coumadin, Jantoven); aspirin; other NSAIDs such as ibuprofen (Advil, Motrin) and ketoprofen; oral steroids such as dexamethasone, methylprednisolone (Medrol), and prednisone (Rayos); selective serotonin reuptake inhibitors (SSRIs) such as citalopram (Celexa), fluoxetine (Prozac, Sarafem, Selfemra, in Symbyax), fluvoxamine (Luvox), paroxetine (Brisdelle, Paxil, Pexeva), and sertraline (Zoloft); or serotonin norepinephrine reuptake inhibitors (SNRIs) such as desvenlafaxine (Khedezla, Pristiq), duloxetine (Cymbalta), and venlafaxine (Effexor XR). Also tell your doctor if you have or have ever had ulcers, bleeding in your stomach or intestines, or other bleeding disorders. If you experience any of the following symptoms, stop taking naproxen and call your doctor: stomach pain, heartburn, vomit that is bloody or looks like coffee grounds, blood in the stool, or black and tarry stools.

Keep all appointments with your doctor and the laboratory. Your doctor will monitor your symptoms carefully and will probably order certain tests to check your body’s response to naproxen. Be sure to tell your doctor how you are feeling so that your doctor can prescribe the right amount of medication to treat your condition with the lowest risk of serious side effects.

Your doctor or pharmacist will give you the manufacturer’s patient information sheet (Medication Guide) when you begin treatment with prescription naproxen and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (https://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer’s website to obtain the Medication Guide.

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:

Naproxen sodium 220 mg (naproxen 200 mg) for pain reliever/fever reducer
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

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.

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/[↩]
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/[↩][↩]
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[↩][↩]
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/[↩]
http://labeling.bayercare.com/omr/online/aleve-D-sinus-cold-caplets.pdf[↩]
American Society of Health System Pharmacists; AHFS Drug Information 2009. Bethesda, MD. (2009), p. 2169[↩][↩]
American Society of Health System Pharmacists; AHFS Drug Information 2009. Bethesda, MD. (2009), p. 2166[↩][↩]
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[↩][↩][↩]
American Society of Health System Pharmacists; AHFS Drug Information 2009. Bethesda, MD. (2009), p. 2168[↩][↩][↩]
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[↩]
Ray PE, Rigolizzo D; Am J Dis Child 142 (5): 524-5 (1988). https://www.ncbi.nlm.nih.gov/pubmed/3358393[↩][↩][↩]
Becker-Cohen R, Frishberg Y; Eur J Pediatr 160 (5): 293-5 (2001). https://www.ncbi.nlm.nih.gov/pubmed/11388597[↩][↩]
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[↩][↩]
Talati AJ et al; Am J Perinatol 17 (2): 69-71(2000). https://www.ncbi.nlm.nih.gov/pubmed/11023164[↩][↩]
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[↩][↩]
Maerker JM et al; Hautarzt 52 (11): 1026-9 (2001). https://www.ncbi.nlm.nih.gov/pubmed/11757457[↩][↩][↩]
Waugh PK, Keatinge DW; Drug Intell Clin Pharm 17 (7-8): 549-50 (1983). https://www.ncbi.nlm.nih.gov/pubmed/6872850[↩]
Briscoe-Dwyer L Etzel JV; Pharmacother 28 (9): 1110; 1994[↩][↩]

Zyrtec

12.7K views

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

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.

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/[↩][↩]
Weber-Schoendorfer C, Schaefer C; Reprod Toxicol 26 (1): 19-23 (2008). https://www.sciencedirect.com/science/article/pii/S0890623808001238[↩][↩][↩]
American Society of Health System Pharmacists; AHFS Drug Information 2009. Bethesda, MD. (2009), p. 27-8[↩]
American Society of Health System Pharmacists; AHFS Drug Information 2009. Bethesda, MD. (2009), p. 27[↩][↩][↩][↩]
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[↩][↩][↩]
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[↩][↩]
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[↩][↩]
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[↩]
Fraunfelder FW, Fraunfelder FT; Am J Ophthalmol 137 (2): 355-7;2004 https://www.ncbi.nlm.nih.gov/pubmed/14962433[↩]
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[↩][↩][↩]
US Natl Inst Health; DailyMed. Current Medication Information for Zyrtec – cetirizine hydrochloride https://dailymed.nlm.nih.gov/dailymed/index.cfm[↩]
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[↩][↩][↩]
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[↩]

Tylenol

8.94K views

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.

IMPORTANT WARNING

Taking too much acetaminophen can cause liver damage, sometimes serious enough to require liver transplantation or cause death. You might accidentally take too much acetaminophen if you do not follow the directions on the prescription or package label carefully, or if you take more than one product that contains acetaminophen.

To be sure that you take acetaminophen safely, you should:

not take more than one product that contains acetaminophen at a time. Read the labels of all the prescription and nonprescription medications you are taking to see if they contain acetaminophen. Be aware that abbreviations such as APAP, AC, Acetaminophen, Acetaminoph, Acetaminop, Acetamin, or Acetam. may be written on the label in place of the word acetaminophen. Ask your doctor or pharmacist if you don’t know if a medication that you are taking contains acetaminophen.
take acetaminophen exactly as directed on the prescription or package label. Do not take more acetaminophen or take it more often than directed, even if you still have fever or pain. Ask your doctor or pharmacist if you do not know how much medication to take or how often to take your medication. Call your doctor if you still have pain or fever after taking your medication as directed.
be aware that you should not take more than 4000 mg of acetaminophen per day. If you need to take more than one product that contains acetaminophen, it may be difficult for you to calculate the total amount of acetaminophen you are taking. Ask your doctor or pharmacist to help you.
tell your doctor if you have or have ever had liver disease.
not take acetaminophen if you drink three or more alcoholic drinks every day. Talk to your doctor about the safe use of alcohol while you are taking acetaminophen.
stop taking your medication and call your doctor right away if you think you have taken too much acetaminophen, even if you feel well.

Talk to your pharmacist or doctor if you have questions about the safe use of acetaminophen or acetaminophen-containing products.

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

Weight (lb)	Age (yr)	Dose (mL)*
Under 24	Under 2 years	Ask a doctor
24-35	2-3 years	5 mL

*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

Weight (lb)	Age (yr)	Dose (mL)*
Under 24	Under 2	Ask a doctor
24-35	2-3 years	5 mL
36-47	4-5 years	7.5 mL
48-59	6-8 years	10 mL
60-71	9-10 years	12.5 mL
72-95	11 years	15 mL

*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:

Anorexia, nausea, vomiting, malaise, and diaphoresis (which inappropriately may prompt administration of additional acetaminophen);
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;
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
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

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.

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/[↩][↩]
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[↩][↩]
Is exposure during pregnancy to acetaminophen/paracetamol disrupting female reproductive development? Endocr Connect. 2018, Jan; 7(1):149-158.[↩][↩][↩][↩]
American Society of Health-System Pharmacists 2013; Drug Information 2013. Bethesda, MD. 2013, p. 2209[↩][↩][↩][↩][↩]
Walls L et al; J Perinatol 27 (2): 133-5; 2007[↩]
Nogen A, Bremmer J; J Pediatr 92 (MAY): 832; 1978[↩][↩]
Davis AM et al; Am J Med 74 (2): 349; 1983[↩]
Gill EJ t al; J Reprod Med 47 (7): 584-6; 2002[↩]
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[↩][↩][↩][↩][↩]
American Society of Health-System Pharmacists 2013; Drug Information 2013. Bethesda, MD. 2013, p. 2211[↩][↩]
OLSON, K.R. (Ed). Poisoning and Drug Overdose, Sixth Edition. McGraw-Hill, New York, NY 2012, p. 69[↩]
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[↩][↩]
American Society of Health-System Pharmacists 2013; Drug Information 2013. Bethesda, MD. 2013, p. 2210[↩][↩][↩]
Possamai LA et al; Crit Care Med 41 (11): 2543-50; 2013[↩][↩]
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[↩]
US Natl Inst Health; DailyMed. Current Medication Information for OFIRMEV (acetaminophen) injection, solution (October 2013). Available from, as of March 6, 2014[↩]

Benadryl

9.53K views

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.

American Society of Health-System Pharmacists 2013; Drug Information 2013. Bethesda, MD. 2013, p. 10[↩][↩][↩][↩][↩][↩][↩][↩][↩]
Troy, D.B. (Ed); Remmington The Science and Practice of Pharmacy. 21 st Edition. Lippincott Williams & Williams, Philadelphia, PA 2005, p. 1545[↩][↩][↩][↩]
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[↩]
Benzodiazepines. https://mothertobaby.org/fact-sheets/benzodiazepines-pregnancy/pdf/[↩][↩]
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[↩]
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[↩]
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[↩]
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[↩]
OLSON, K.R. (Ed). Poisoning and Drug Overdose, Sixth Edition. McGraw-Hill, New York, NY 2012, p. 478[↩]
Krenzelok EP et al; Ann Emerg Med 11 (4): 212-3; 1982 https://www.ncbi.nlm.nih.gov/pubmed/7073039[↩][↩]
Aronson JK. Anticholinergic drugs. In: Aronson JK, ed. Meyler’s Side Effects of Drugs. 16th ed. Waltham, MA: Elsevier; 2016:534-539.[↩]
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.[↩][↩]
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/[↩]
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[↩][↩]
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[↩][↩]
[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[↩][↩][↩][↩][↩]
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[↩][↩][↩]
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/[↩][↩]
Emadian SM et al; Am J Emerg Med 14 (6): 574-6; 1996 https://www.ncbi.nlm.nih.gov/pubmed/8857809[↩]
Lopez-Barbeito B et al; Pacing Clin Electrophysiol 28 (7): 730-2;2005 https://www.ncbi.nlm.nih.gov/pubmed/16008813[↩][↩]
Baker AM et al; J Forensic Sci 48 (2): 425-8;2003 https://www.ncbi.nlm.nih.gov/pubmed/12665005[↩][↩][↩][↩]

Alka seltzer

14.8K views

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.

Motrin

8.97K views

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.

IMPORTANT WARNING

If you will be undergoing a coronary artery bypass graft (CABG; a type of heart surgery), you should not take ibuprofen right before or right after the surgery.

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)

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.

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).

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).

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.

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
Age	Dosage
Adults and Children 12 years and older	take 1 caplet every 4 to 6 hours while symptoms persist if pain or fever does not respond to 1 caplet, 2 caplets may be used do not exceed 6 caplets in 24 hours, unless directed by a doctor
Children under 12 years	Ask a doctor

Motrin IB Caplets Active ingredients (in each caplet):

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

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
Age	Dosage
Adults and Children 12 years and older	take 1 caplet every 4 to 6 hours while symptoms persist if pain or fever does not respond to 1 caplet, 2 caplets may be used do not exceed 6 caplets in 24 hours, unless directed by a doctor
Children under 12 years	Ask a doctor

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

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
Age	Dosage
Adults and Children 12 years and over	take 2 caplets at bedtime do not take more than 2 caplets in 24 hours

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

Diphenhydramine citrate 38 mg/Purpose: Nighttime sleep-aid
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

Dosing Chart
Weight (lb)	Age (yr)	Dose (mL)*
under 24 lbs	under 2 years	Ask a doctor
24-35 lbs	2-3 years	5 mL
36-47 lbs	4-5 years	7.5 mL
48-59 lbs	6-8 years	10 mL
60-71 lbs	9-10 years	12.5 mL
72-95 lbs	11 years	15 mL

*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

Dosing Chart
Weight (lb)	Age (months)	Dose (mL)
Under 6 months		Ask a doctor
12-17 lbs	6-11 months	1.25 mL
18-23 lbs	12-23 months	1.875 mL

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

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

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

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

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

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.

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

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

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.

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

Drugs

What is Pepto Bismol

How does Pepto Bismol work?

Why does Pepto-Bismol sometimes darken the tongue/stool and how long does it last?

Can I give Pepto-Bismol to my child?

I have been giving Pepto-Bismol to my child when he/she had an upset stomach – should I be concerned?

What does the label say about Reye’s syndrome and Pepto-Bismol?

How should Pepto Bismol be used?

Should I take Pepto-Bismol with or without food?

When can I take Pepto-Bismol?

Before taking Pepto Bismol – Precautions

Allergies

Pediatric patients

Geriatric patients

Breastfeeding

Diabetic patients

Drug Interactions

Other Interactions

Other Medical Problems

Pepto Bismol Pregnancy and Breastfeeding

Pepto Bismol Pregnancy Warnings

Pepto Bismol Breastfeeding Warnings

What does Pepto Bismol do

Pepto Bismol uses

Pepto Bismol Dosing

What should I do if I forget a dose?

What special dietary instructions should I follow?

What should I do if I forget a dose?

Pepto Bismol dosage

Pepto Bismol Liquid

Pepto Bismol Liquid Usage Warning

Pepto Bismol Liquid directions of use

Pepto-Bismol Swallowable Caplets

Pepto-Bismol Swallowable Caplets Usage Warning

Pepto-Bismol Swallowable Caplets directions of use

Pepto-Bismol Original Chewable Tablets

Pepto-Bismol Original Chewable Tablets Usage Warning

Pepto-Bismol Original Chewable Tablets directions of use

Children’s Pepto Antacid

Children’s Pepto Antacid Chewable Tablets Usage Warning

Children’s Pepto Antacid Chewable Tablets directions of use

Pepto Bismol side effects

Human Toxicity Reports

Pepto Bismol overdose

What is Zantac

How long does Zantac take to work

How long will I take Zantac for?

Zantac side effects long term

Are there similar medicines to Zantac?

Are there other indigestion medicines?

Can I take Zantac with other indigestion medicines?

Can I drive or ride a bike after taking Zantac?

Can I drink alcohol with Zantac?

Is there any food or drink I need to avoid?

Can lifestyle changes help?

Who can and can’t take Zantac

Pediatric Use

Geriatric Use

Pregnancy and breastfeeding

Zantac and breastfeeding

Cautions with other medicines

What is Zantac used for

Zantac uses

Before taking Zantac – Precautions

How and when to take Zantac

How to take Zantac

How much Zantac will I take?

Will my dose go up or down?

What if I forget to take Zantac?

What if I take too much Zantac?

Zantac dosage

Zantac 75

Zantac 75 Warnings

Maximum Strength Zantac 150

Maximum Strength Zantac 150 Warnings

Zantac side effects

Serious side effects

How to cope with side effects

Human Toxicity Reports

Zantac overdose