What is acetaminophen-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 other purposes not listed in this medication guide.

Precautions

Do not take this medication if you are allergic to acetaminophen, diphenhydramine, or any antihistamine.

Before using acetaminophen and diphenhydramine, tell your doctor if you are allergic to any drugs, or if you have:

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

Do not take this medication without first talking to your doctor if you drink more than three alcoholic beverages per day or if you have had alcoholic liver disease (cirrhosis). You may not be able to take medication that contains acetaminophen.

It is not known whether acetaminophen and diphenhydramine will harm an unborn baby. Before using acetaminophen, tell your doctor if you are pregnant.

This medication may 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.

This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Do not use any other cough, cold, allergy, pain, or sleep medication without first asking your doctor or pharmacist. Acetaminophen (sometimes abbreviated as "APAP”) and diphenhydramine are contained in many combination medicines. If you take certain products together you may accidentally take too much of one or more types of medicine. Read the label of any other medicine you are using to see if it contains acetaminophen, APAP or diphenhydramine.

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

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Instructions

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include dizziness, drowsiness, feeling restless or nervous, dry mouth, warmth or tingly feeling, nausea, vomiting, diarrhea, stomach pain, loss of appetite, increased sweating, seizure (convulsions), or coma.

Take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and take only the next regularly scheduled dose. Do not take a double dose of this medication.

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Side Effects

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 medication and call your doctor at once if you have any of these serious side effects:

  • 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, stomach pain, low fever, 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;
  • restless or excitability (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. You may report side effects to FDA at 1-800-FDA-1088.

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Interactions

Cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety can add to sleepiness caused by acetaminophen and diphenhydramine. Tell your doctor if you regularly use any of these other medicines.

The following drugs can interact with acetaminophen and diphenhydramine. Tell your doctor if you are using any of these:

  • isoniazid;
  • zidovudine (Retrovir, AZT);
  • an antidepressant;
  • a diuretic (water pill);
  • gout medications such as probenecid (Benbemid) or sulfinpyrazone (Anturane);
  • medication to treat irritable bowel syndrome;
  • bladder or urinary medications such as oxybutynin (Ditropan, Oxytrol) or tolterodine (Detrol);
  • aspirin or salicylates (such as Disalcid, Doan's Pills, Dolobid, Salflex, Tricosal, and others); or
  • seizure medication such as phenytoin (Dilantin) or phenobarbital (Luminal, Solfoton).

This list is not complete and there may be other drugs that can interact with acetaminophen and diphenhydramine. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Other Names

Anacin P.M. Aspirin Free, Bayer Select Max Strength Night Time Pain, Coricidin Night Time Cold Relief, Excedrin PM, Excedrin PM Caplet, Genapap PM, Legatrin PM, Mapap PM, Midol PM, Sominex Pain Relief Formula, Tylenol Extra Strength PM, Tylenol Extra Strength PM Vanilla Caplet, Tylenol PM, Tylenol Sore Throat Nighttime, Unisom with Pain Relief, acetaminophen-diphenhydrAMINE, diphenhydrAMINE-acetaminophen, Headache Relief PM, Percogesic Extra Strength, Tylenol Cold Relief Caplet, Tylenol Cold Relief Nighttime, Tylenol Cold Relief Nighttime Caplet, Tylenol Extra Strength PM Rapid Release Gelcaps, and Tylenol Severe Allergy Caplet

Available Strengths & Dosages


Route Form Strength
oral liquid 1000 mg-50 mg/30 mL

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Disclaimer

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2004 Cerner Multum, Inc. Version 2.05. Revision date 8/23/04

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