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| Other drug names: | A B C D E F G H I J K L M N O P Q R S T U V W X Y Z 0-9 |
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[Posted 10/09/2008] FDA notified healthcare professionals and consumers that the Consumer Healthcare Products Association (CHPA) is voluntarily modifying the product labels for consumers of over the counter (OTC) cough and cold medicines to state do not use in children under 4 years of age. FDA supports CHPA members to help prevent and reduce misuse and to better inform consumers about the safe and effective use of these products for children. FDA continues to assess the safety and efficacy of these products and to revise its OTC list of approved ingredients and amounts for these medicines. Parents and care givers should adhere to the dosage instructions and warnings on the label that accompanies OTC cough and cold medications before giving the product to children, and should consult their healthcare professionals if they have any questions or concerns. For more information visit the FDA website at: http://www.fda.gov/Safety/MedWatch and http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements. |
Acetaminophen is used to relieve mild to moderate pain from headaches, muscle aches, menstrual periods, colds and sore throats, toothaches, backaches, and 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 (pain relievers) and antipyretics (fever reducers). It works by changing the way the body senses pain and by cooling the body.
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
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, read the package label carefully to make sure that it is the right product for the age of the child. Do not give children acetaminophen products that are made for adults. Some products for adults and older children may contain too much acetaminophen for a younger child. Drops made for infants are more concentrated (much more medication in each drop) than liquids made for older children. Check the package label 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. Ask your child's doctor if you don't know how much medication to give your child.
Acetaminophen comes in combination with other medications to treat cough and cold symptoms. Ask your doctor or pharmacist for advice on which product is best for your symptoms. Check nonprescription cough and cold product labels carefully before using two or more products at the same time. These products may contain the same active ingredient(s) and taking them together could cause you to receive an overdose. This is especially important if you will be giving cough and cold medications to a child.
Swallow the extended-release tablets whole; do not split, chew, crush, or dissolve them.
Place the orally disintegrating tablet ('Meltaways') 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:
Stop taking acetaminophen and call your doctor if your symptoms get worse, you develop new or unexpected symptoms, including redness or swelling, 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, 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 occurs 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.
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.
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
Before taking acetaminophen,
Unless your doctor tells you otherwise, continue your normal diet.
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.
Acetaminophen may cause side effects.
Some side effects can be serious. If you experience any of the following symptoms, call your doctor immediately:
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 [at http://www.fda.gov/Safety/MedWatch] or by phone [1-800-332-1088].
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 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:
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
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.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
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Last Reviewed - 02/01/2009

AHFS® Consumer Medication Information. © Copyright, 2009. The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.
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Page last updated: 18 November 2009 |