Acetaminophen (patient information)

# IMPORTANT WARNING
 The Centers for Disease Control and Prevention (CDC) issued a Morbidity and Mortality Weekly Report (MMWR) article describing three deaths in U.S. infants aged less than 12 months associated with cough and cold medications. These medications were determined by medical examiners or coroners to be the underlying cause of death. The cases described in this report underscore the need for clinicians to use caution when prescribing and caregivers to use caution when administering cough and cold medications to children aged less than 2 years. For more information visit the FDA website at: #coughcold and .

# Why this medication is prescribed
Acetaminophen is used to relieve mild to moderate pain from headaches, muscle aches, menstrual periods, colds and sore throats, toothaches, backaches, reactions to vaccinations (shots), and to reduce fever. 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 and antipyretics. It works by changing the way the body senses pain and by cooling the body.

# How this medication should be used
Acetaminophen comes as a tablet, chewable tablet, capsule, suspension or solution (liquid), drops (concentrated 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. Take acetaminophen exactly as directed. Do not take more or less of it or take it more often than directed on the package label or prescribed by your doctor. Taking more than the recommended amount may cause damage to your liver.
If you are giving acetaminophen to your child, check the chart on the package 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. Do not give children acetaminophen products that are made for adults. Ask your child's doctor if you don't know how much medication to give your child.
Swallow the extended-release tablets whole; do not split, chew, crush, or dissolve them.
Place the orally disintegrating tablet in your mouth and allow to dissolve or chew it before swallowing.
Shake the suspension and drops well before each use to mix the medication evenly. Use the measuring cup provided by the manufacturer to measure each dose of the solution or suspension, and use the dosing device provided to measure each dose of the drops. Use the dosing device to slowly release the drops directly into the child's mouth near the inner cheek. Do not mix the drops with baby formula.
To insert an acetaminophen suppository into the rectum, follow these steps:
- Remove the wrapper.
- Dip the tip of the suppository in water.
- Lie down on your left side and raise your right knee to your chest. (A left-handed person should lie on the right side and raise the left knee.)
- Using your finger, insert the suppository into the rectum, about 12 to 1 inch in infants and children and 1 inch in adults. Hold it in place for a few moments.
- Stand up after about 15 minutes. Wash your hands thoroughly and resume your normal activities.
Stop taking acetaminophen 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 gets worse or lasts more than 3 days. Also stop giving acetaminophen 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 your child's pain lasts for longer than 5 days or fever get worse or lasts longer than 3 days.
Do not give acetaminophen to a child who has a sore throat that is severe or does not go away, or that comes along with fever, headache, rash, nausea, or vomiting. Call the child's doctor right away, because these symptoms may be signs of a more serious condition.

# Other uses for this medicine
Acetaminophen may also be used in combination with aspirin and caffeine to relieve the pain associated with migraine headache.
This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

# Special precautions
Before taking acetaminophen:
- tell your doctor and pharmacist if you are allergic to acetaminophen, any other medications, or any of the ingredients in the product.
- do not take more two or more products that contain acetaminophen at the same time. Many prescription and nonprescription medications contain acetaminophen in combination with other medications. Read the package labels or ask your doctor or pharmacist to be sure that you do not take more than one product that contains acetaminophen at a time.
- 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 any serious medical condition.
- 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, ask your doctor if you should take acetaminophen. Ask your doctor or pharmacist about the safe use of alcoholic beverages while taking acetaminophen.
- if you have phenylketonuria (PKU, a inherited condition in which a special diet must be followed to prevent mental retardation), you should know that some brands of the chewable tablets may contain phenylalanine.

# Special dietary instructions
Unless your doctor tells you otherwise, continue your normal diet.

# What to do if you forget a dose
This medication is usually taken as needed. If your doctor has told you to take acetaminophen 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.

# Side Effects
Acetaminophen may cause side effects.
Some side effects can be serious. If you experience any of the following symptoms, call your doctor immediately:
- rash
- hives
- itching
- swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
- hoarseness
- difficulty breathing or swallowing
Acetaminophen may cause other side effects. Call your doctor if you have 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  or by phone .

# Storage conditions needed for this medication
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

# In case of emergency/overdose   Return to top
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
If someone takes more than the recommended dose of acetaminophen, get medical help immediately, even if the person does not have any symptoms. Symptoms of overdose may include:
- nausea
- vomiting
- loss of appetite
- sweating
- extreme tiredness
- unusual bleeding or bruising
- pain in the upper right part of the stomach
- yellowing of the skin or eyes
- flu-like symptoms

# Other information
Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking acetaminophen.
Ask your pharmacist any questions you have about acetaminophen.

# Brand names
- Acephen
- Anacin Aspirin Free Maximum Strength Tablets
- Capital and Codeine
- Endocet
- Excedrin P.M. Caplets
- Excedrin P.M. Geltabs
- Excedrin P.M. Tablets
- Excedrin Extra-Strength Caplets
- Excedrin Extra-Strength Tablets
- Excedrin Migraine Caplets
- Excedrin Migraine Geltabs
- Excedrin Migraine Tablets
- FeverAll Children's
- FeverAll Infants'
- FeverAll Junior Strength
- Gelpirin
- Genapap
- Genapap Children's
- Genapap Drops Infant's
- Genapap Extra Strength Caplets
- Genapap Extra Strength Tablets
- Genapap Gel-Coat Caplets
- Genebs
- Genebs Extra Strength Caplets
- Genebs Extra Strength Tablets
- Goody's Extra Strength Tablets
- Goody's Fast Pain Relief Tablets
- Goody's Headache Powders
- Liquiprin Drops
- Roxicet
- Supac
- Tylenol
- Tylenol Arthritis Pain Extended Relief Caplets
- Tylenol Meltaways Children's
- Tylenol Concentrated Drops Infant's
- Tylenol Extra Strength Adult
- Tylenol Extra Strength Caplets
- Tylenol Extra Strength Gelcaps
- Tylenol Extra Strength Geltabs
- Tylenol Extra Strength Tablets
- Tylenol Meltaways Junior Strength
- Tylenol Suspension Children's
- Tylenol with Codeine Elixir
- Tylenol with Codeine No. 3
- Tylenol with Codeine No. 4
- Tylox
- Vanquish Caplets
- Wygesic

# Brand names of combination products
- Allerest No Drowsiness containing Acetaminophen and Pseudoephedrine Hydrochloride
- Axocet containing Acetaminophen and Butalbital
- Benadryl Severe Allergy and Sinus Headache Maximum Strength Caplets containing Acetaminophen, Diphenhydramine Hydrochloride, and Pseudoephedrine Hydrochloride
- Bupap containing Acetaminophen and Butalbital
- Dristan Cold No Drowsiness Formula Maximum Strength Caplets containing Acetaminophen and Pseudoephedrine Hydrochloride
- Duradrin containing Acetaminophen, Dichloralphenazone, and Isometheptene Mucate
- Excedrin Aspirin-Free Caplets containing Acetaminophen and Caffeine
- Excedrin Aspirin-Free Geltabs containing Acetaminophen and Caffeine
- Excedrin Quicktabs containing Acetaminophen and Caffeine
- I.D.A. containing Acetaminophen, Dichloralphenazone, and Isometheptene Mucate
- Midol Menstrual Formula Maximum Strength Caplets containing Acetaminophen, Caffeine, and Pyrilamine Maleate
- Midol Menstrual Formula Maximum Strength Gelcaps containing Acetaminophen, Caffeine, and Pyrilamine Maleate
- Midol PMS Maximum Strength Caplets containing Acetaminophen, Pamabrom, and Pyrilamine Maleate
- Midol PMS Maximum Strength Gelcaps containing Acetaminophen, Pamabrom, and Pyrilamine Maleate
- Midol Teen Menstrual Formula Caplets containing Acetaminophen and Pamabrom
- Midrin containing Acetaminophen, Dichloralphenazone, and Isometheptene Mucate
- Ornex Caplets containing Acetaminophen and Pseudoephedrine Hydrochloride
- Ornex Maximum Strength Caplets containing Acetaminophen and Pseudoephedrine Hydrochloride
- Pamprin Maximum Pain Relief Caplets containing Acetaminophen, Magnesium Salicylate, and Pamabrom
- Pamprin Multi-Symptom containing Acetaminophen, Pamabrom, and Pyrilamine Maleate
- Percogesic containing Acetaminophen and Phenyltoloxamine Citrate
- Percogesic Extra Strength Caplets containing Acetaminophen and Diphenhydramine Hydrochloride
- Phrenilin containing Acetaminophen and Butalbital
- Phrenilin Forte containing Acetaminophen and Butalbital
- Premsyn PMS Caplets containing Acetaminophen, Pamabrom, and Pyrilamine Maleate
- Sedapap containing Acetaminophen and Butalbital
- Sinarest No Drowsiness Tablets containing Acetaminophen and Pseudoephedrine Hydrochloride
- Sine-Off Maximum Strength No Drowsiness Formula Caplets containing Acetaminophen and Pseudoephedrine Hydrochloride
- Sinutab containing Acetaminophen and Pseudoephedrine Hydrochloride
- Sinutab Sinus Medication Maximum Strength Without Drowsiness Tablets containing Acetaminophen and Pseudoephedrine Hydrochloride
- Sominex Pain Relief Formula containing Acetaminophen and Diphenhydramine Hydrochloride
- St. Joseph Cold Tablets for Children containing Acetaminophen and Phenylpropanolamine Hydrochloride
- Sudafed Sinus & Headache Caplets containing Acetaminophen and Pseudoephedrine Hydrochloride
- Sudafed Sinus & Headache Maximum Strength Tablets containing Acetaminophen and Pseudoephedrine Hydrochloride
- Tylenol Allergy Sinus NightTime Maximum Strength Caplets containing Acetaminophen, Diphenhydramine Hydrochloride, and Pseudoephedrine Hydrochloride
- Tylenol Cold Decongestant and Fever Reducer Concentrated Drops Infant's containing Acetaminophen and Pseudoephedrine Hydrochloride
- Tylenol Flu NightTime Maximum Strength Gelcaps containing Acetaminophen, Diphenhydramine Hydrochloride, and Pseudoephedrine Hydrochloride
- Tylenol PM Extra Strength Caplets containing Acetaminophen and Diphenhydramine Hydrochloride
- Tylenol PM Extra Strength Gelcaps containing Acetaminophen and Diphenhydramine Hydrochloride
- Tylenol PM Extra Strength Geltabs containing Acetaminophen and Diphenhydramine Hydrochloride
- Tylenol Sinus Geltabs Maximum Strength Tablets containing Acetaminophen and Pseudoephedrine Hydrochloride
- Tylenol Sinus Medication Maximum Strength Geltabs containing Acetaminophen and Pseudoephedrine Hydrochloride
- Tylenol Sinus Medication Maximum-Strength Caplets containing Acetaminophen and Pseudoephedrine Hydrochloride
- Tylenol Sinus Medication Maximum-Strength Gelcaps containing Acetaminophen and Pseudoephedrine Hydrochloride
- Tylenol Women's Caplets containing Acetaminophen and Pamabrom
- Ultracet containing Acetaminophen and Tramadol Hydrochloride
- Women's Tylenol Menstrual Relief Caplets containing Acetaminophen and Pamabrom