Acetaminophen/Diphenhydramine, Oral

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KEY POINTS

• This medicine is taken by mouth to relieve pain and help you fall asleep. Take it exactly as directed. Taking too much may cause liver damage. Read the labels of other products to find out which may contain acetaminophen.
• This medicine may cause severe skin reactions, liver damage, or other unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: antihistamine; analgesic (pain reliever)

Generic and brand names: acetaminophen/diphenhydramine, oral; Acetaminophen PM; Excedrin PM; Legatrin PM; Mapap PM; Tylenol PM; (There may be other brand names for this medicine.)

What is this medicine used for?

This medicine combines a pain reliever with an antihistamine that causes drowsiness. It is taken by mouth to relieve nighttime pain and to help you fall asleep.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• A stomach ulcer
• Glaucoma
• Heart disease
• Kidney disease
• Liver disease
• Lung problems such as asthma or COPD
• Thyroid problems
• Trouble urinating or an enlarged prostate gland

To avoid the risk of taking an overdose, tell your provider or pharmacist about all of the other medicines you take. This includes nonprescription products.

If you drink more than 3 alcoholic drinks per day, ask your healthcare provider if you should take this medicine.

Females of childbearing age: Tell your healthcare provider if you are pregnant. Do not breast-feed while you are taking this medicine without your healthcare provider's approval.

How do I take it?

You can buy some forms of this medicine without a prescription. Check the label on the medicine for directions about your specific dose. Follow the directions on the package or take this medicine exactly as prescribed. Do not take more of it or take it more often than recommended. Taking too much can make you very drowsy and can damage your liver.

Check with your healthcare provider before using this medicine in children under age 12.

You may take this medicine with or without food.

If you have the liquid form of this medicine, use the measuring spoon, cup, dropper, or oral syringe that comes with the medicine, or ask your pharmacist for one. Do not use a kitchen spoon because the dose may not be correct.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: nausea, vomiting, diarrhea, stomach pain, dizziness, drowsiness, dry mouth, sweating, seizures, confusion, irregular heartbeat, dark urine, yellowing of the skin or eyes, hallucinations, coma, restlessness, trouble urinating.

What should I watch out for?

This medicine may cause severe liver damage if:

• An adult takes more than 3000-4000 mg in 24 hours
• A child takes more than 5 doses in 24 hours
• You take this medicine with other drugs that contain acetaminophen
• An adult has 3 or more alcoholic drinks every day while using this product

Many prescription and nonprescription medicines for pain, headache, and sinus congestion contain acetaminophen. If you cannot tell if you are taking more than the recommended dosage per day, ask your healthcare provider and pharmacist to review all of your medicines.

Do not drink alcohol while taking this medicine. Ask your healthcare provider about this.

Do not take this medicine for more than 2 weeks. If you still have trouble sleeping after 2 weeks, contact your healthcare provider. If pain gets worse or lasts for more than 10 days, or if fever gets worse or lasts more than 3 days, contact your healthcare provider.

When taken at bedtime, this medicine may make you drowsy the next day. Do not drive or operate machinery unless you are fully alert.

Adults over the age of 65 may be at greater risk for side effects. Talk with your healthcare provider about this.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat); seizures.

Serious (Report these to your healthcare provider right away.): Severe tiredness, weakness, fever, yellowing of the skin or eyes, nausea, stomach pain, unusual bruising or bleeding, trouble urinating, irregular or pounding heartbeat, chest pain, confusion, nervousness, vision problems.

Other: Drowsiness, heavier phlegm, sore throat, dry mouth, constipation.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Antianxiety medicines such as alprazolam (Xanax), chlordiazepoxide, clonazepam (Klonopin), clorazepate (Gen-Xene, Tranxene), diazepam (Valium), lorazepam (Ativan), and oxazepam
• Anticholinergic medicines such as amantadine (Symmetrel), atropine/diphenoxylate (Lomotil), belladonna, benztropine (Cogentin), dicyclomine (Bentyl), hyoscyamine (HyoMax, Levbid, Levsin), methscopolamine (Pamine), propantheline, and trihexyphenidyl
• Antidepressants such as amitriptyline, amoxapine, citalopram (Celexa), clomipramine, desipramine (Norpramin), desvenlafaxine (Pristiq), duloxetine (Cymbalta), escitalopram (Lexapro), fluoxetine (Prozac), fluvoxamine (Luvox), imipramine (Tofranil), nortriptyline (Pamelor), sertraline (Zoloft), and venlafaxine (Effexor)
• Antihistamines such as azelastine (Astelin, Astepro), brompheniramine, chlorpheniramine (Chlor-Trimeton), clemastine (Tavist), diphenhydramine (Benadryl), hydroxyzine (Vistaril), and meclizine (Dramamine)
• Antipsychotic medicines such as aripiprazole (Abilify), asenapine (Saphris), chlorpromazine, clozapine (Clozaril, FazaClo), fluphenazine, haloperidol (Haldol), iloperidone (Fanapt), olanzapine (Zyprexa), paliperidone (Invega), perphenazine, pimozide (Orap), quetiapine (Seroquel), risperidone (Risperdal), thioridazine, trifluoperazine, and ziprasidone (Geodon)
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), felbamate (Felbatol), gabapentin (Neurontin), lamotrigine (Lamictal), levetiracetam (Keppra), oxcarbazepine (Trileptal), phenytoin (Dilantin, Phenytek), primidone (Mysoline), tiagabine (Gabitril), topiramate (Qudexy, Topamax, Trokendi), and valproic acid (Depacon, Depakene, Depakote)
• Cholestyramine (Prevalite)
• Diflunisal
• Doxepin (Silenor)
• Isoniazid
• MAO inhibitors such as isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate) (Do not take this medicine and an MAO inhibitor within 14 days of each other.)
• Medicines to treat breathing or lung problems such as ipratropium (Atrovent) and tiotropium (Spiriva)
• Muscle relaxants such as baclofen (Gablofen, Lioresal), carisoprodol (Soma), cyclobenzaprine (Amrix), dantrolene (Dantrium), methocarbamol (Robaxin), and tizanidine (Zanaflex)
• Narcotic pain medicines such as codeine, fentanyl (Abstral, Actiq, Duragesic, Fentora, Sublimaze), hydrocodone/acetaminophen (Norco, Vicodin), hydromorphone (Dilaudid, Exalgo), meperidine (Demerol), methadone (Dolophine, Methadose), morphine (Kadian, MS Contin), oxycodone (OxyContin, Roxicodone), and oxycodone/acetaminophen (Percocet, Roxicet)
• Natural remedies such as gotu kola, kava, St. John's wort, and valerian
• Nausea medicines such as prochlorperazine (Compro) and promethazine
• Other allergy, cold, or cough medicines that contain an antihistamine, including products used on the skin
• Other medicines that contain acetaminophen
• Paroxetine (Brisdelle, Paxil, Pexeva)
• Rifampin (Rifadin)
• Sleeping pills such as butabarbital (Butisol), eszopiclone (Lunesta), flurazepam, phenobarbital, temazepam (Restoril), triazolam (Halcion), zaleplon (Sonata), and zolpidem (Ambien, Edluar, Intermezzo)
• Warfarin (Coumadin)

Do not drink alcohol while taking this medicine.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicines in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.