Medications and Drugs

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Brand Names: Anacin P.M. Aspirin Free, Coricidin Night Time Cold Relief, Excedrin PM, Excedrin PM Caplet, Excedrin PM Express Gels, Headache Relief PM, Legatrin PM, Mapap PM, Midol PM, Night Time Pain, Percogesic Extra Strength, Percogesic Original Strength, Tylenol Cold Relief Caplet, Tylenol Cold Relief Nighttime, Tylenol Cold Relief Nighttime Caplet, Tylenol Extra Strength PM, Tylenol Extra Strength PM Rapid Release Gelcaps, Tylenol Extra Strength PM Vanilla Caplet, Tylenol PM, Tylenol Sore Throat Nighttime, Unisom with Pain Relief

Generic Name: acetaminophen and diphenhydramine (Pronunciation: a SEET a MIN oh fen and DYE fen HYE dra meen)

• What is acetaminophen and diphenhydramine (Anacin P.M. Aspirin Free, Coricidin Night Time Cold Relief, Excedrin PM, Excedrin PM Caplet, Excedrin PM Express Gels, Headache Relief PM, Legatrin PM, Mapap PM, Midol PM, Night Time Pain, Percogesic Extra Strength, Percogesic Original Strength, Tylenol Cold Relief Caplet, Tylenol Cold Relief Nighttime, Tylenol Cold Relief Nighttime Caplet, Tylenol Extra Strength PM, Tylenol Extra Strength PM Rapid Release Gelcaps, Tylenol Extra Strength PM Vanilla Caplet, Tylenol PM, Tylenol Sore Throat Nighttime, Unisom with Pain Relief)?
• What are the possible side effects of acetaminophen and diphenhydramine?
• What is the most important information I should know about acetaminophen and diphenhydramine?
• What should I discuss with my healthcare provider before taking acetaminophen and diphenhydramine?
• How should I take acetaminophen and diphenhydramine?
• What happens if I miss a dose?
• What happens if I overdose?
• What should I avoid while taking acetaminophen and diphenhydramine?
• What other drugs will affect acetaminophen and diphenhydramine?
• Where can I get more information?

What is acetaminophen and diphenhydramine (Anacin P.M. Aspirin Free, Coricidin Night Time Cold Relief, Excedrin PM, Excedrin PM Caplet, Excedrin PM Express Gels, Headache Relief PM, Legatrin PM, Mapap PM, Midol PM, Night Time Pain, Percogesic Extra Strength, Percogesic Original Strength, Tylenol Cold Relief Caplet, Tylenol Cold Relief Nighttime, Tylenol Cold Relief Nighttime Caplet, Tylenol Extra Strength PM, Tylenol Extra Strength PM Rapid Release Gelcaps, Tylenol Extra Strength PM Vanilla Caplet, Tylenol PM, Tylenol Sore Throat Nighttime, Unisom with Pain Relief)?

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 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 your 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 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 take this medication without a doctor's advice if you have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3 alcoholic beverages per day. You may not be able to take medicine that contains acetaminophen.

Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death.

Avoid drinking alcohol. It may increase your risk of liver damage while taking acetaminophen.

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 which can lead to a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP.

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.

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