acetaminophen and diphenhydramine

What is the most important information I should know about acetaminophen and diphenhydramine?

There are many brands and forms of this medication available and not all brands are listed on this leaflet.

Do not give this medication to a child younger than 4 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children.

Do not take more of this medication than is recommended. An overdose of acetaminophen and diphenhydramine can be fatal.

Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as "APAP") and diphenhydramine are contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen. Check the label to see if a medicine contains acetaminophen or APAP.

Avoid drinking alcohol. It may increase your risk of liver damage while taking acetaminophen, and can add to drowsiness caused by diphenhydramine. Ask a doctor before taking acetaminophen if you drink more than 3 alcoholic beverages per day, and never take more than 2 grams (2000 mg) of acetaminophen per day.

What is acetaminophen and diphenhydramine?

Acetaminophen is a pain reliever and a fever reducer.

Diphenhydramine is an antihistamine. It blocks the effects of the naturally occurring chemical histamine in the body. Diphenhydramine prevents sneezing; itchy, watery eyes and nose; and other symptoms of allergies and hay fever.

The combination of acetaminophen and diphenhydramine is used to treat runny nose, sneezing, watery eyes, and pain or fever caused by allergies, the common cold, or the flu. This medication is also used to treat night time pain and help you sleep.

Acetaminophen and diphenhydramine may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking acetaminophen and diphenhydramine?

You should not take this medication if you are allergic to acetaminophen or diphenhydramine.

Ask a doctor or pharmacist if it is safe for you to take this medicine if you have:

• liver disease;
• glaucoma;
• kidney disease;
• an enlarged prostate; or
• problems with urination.

Do not take this medication without a doctor's advice if you have ever had alcoholic liver disease (cirrhosis). You may not be able to take acetaminophen.

It is not known whether acetaminophen and diphenhydramine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

Acetaminophen and diphenhydramine can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take acetaminophen and diphenhydramine?

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 give this medication to a child younger than 4 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children.

An overdose of acetaminophen can damage your liver. Adults should not take more than 1 gram (1000 mg) of acetaminophen per dose or 4 grams (4000 mg) per day. Ask a doctor before taking acetaminophen if you drink more than 3 alcoholic beverages per day, and never take more than 2 grams (2000 mg) of acetaminophen per day.

One dose of this medicine may contain up to 1000 mg of acetaminophen. Know the amount of acetaminophen in the specific product you are taking.

Take this medicine with food or milk if it upsets your stomach.

This medication can cause unusual results with allergy skin tests. Tell any doctor who treats you that you are taking an antihistamine.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Since this medication is taken as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of acetaminophen and diphenhydramine can be fatal.

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

What should I avoid while taking acetaminophen and diphenhydramine?

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as "APAP") is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen. Check the label to see if a medicine contains acetaminophen or APAP.

Avoid drinking alcohol. It may increase your risk of liver damage while taking acetaminophen, and can add to drowsiness caused by diphenhydramine.

What are the possible side effects of acetaminophen and diphenhydramine?

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

Stop using this medicine and call your doctor at once if you have a serious side effect such as:

• fast, pounding, or uneven heartbeats;
• confusion, hallucinations, unusual thoughts or behavior;
• severe dizziness, anxiety, restless feeling, or nervousness;
• urinating less than usual or not at all;
• easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms; or
• nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

• dryness of the eyes, nose, and mouth;
• blurred vision;
• difficulty urinating;
• dizziness, drowsiness;
• problems with memory or concentration;
• ringing in your ears;
• feeling restless or excited (especially in children); or
• mild nausea, stomach pain, constipation.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect acetaminophen and diphenhydramine?

Before using this medication, tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by diphenhydramine.

Tell your doctor about all other medicines you use, especially:

• isoniazid;
• zidovudine (Retrovir, AZT);
• an antidepressant;
• a diuretic (water pill);
• gout medications such as probenecid (Benemid);
• medication to treat irritable bowel syndrome;
• bladder or urinary medications such as oxybutynin (Ditropan, Oxytrol) or tolterodine (Detrol);
• salicylates such as aspirin, Backache Relief Extra Strength, Novasal, Nuprin Backache Caplet, Doan's Pills Extra Strength, Pepto-Bismol, Tricosal, and others;
• seizure medication such as phenytoin (Dilantin) or phenobarbital (Solfoton).

This list is not complete and other drugs may interact with acetaminophen and diphenhydramine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about acetaminophen and diphenhydramine.

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