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ACETAMINOPHEN (Systemic)

Some commonly used brand names are:

In the U.S.—

• Aceta Elixir ¹
• Aceta Tablets ¹
• Acetaminophen Uniserts ¹
• Actamin ¹
• Actamin Extra ¹
• Actamin Super ²
• Aminofen ¹
• Aminofen Max ¹
• Apacet Capsules ¹
• Apacet Elixir ¹
• Apacet Extra Strength Caplets ¹
• Apacet Extra Strength Tablets ¹
• Apacet, Infants" ¹
• Apacet Regular Strength Tablets ¹
• Aspirin Free Anacin Maximum Strength Caplets ¹
• Aspirin Free Anacin Maximum Strength Gel Caplets ¹
• Aspirin Free Anacin Maximum Strength Tablets ¹
• Aspirin-Free Excedrin Caplets ²
• Banesin ¹
• Bayer Select Maximum Strength Headache Pain Relief Formula ²
• Dapa ¹
• Dapa X-S ¹
• Datril Extra-Strength ¹
• Feverall, Children"s ¹
• Feverall, Infants" ¹
• Feverall Junior Strength ¹
• Feverall Sprinkle Caps, Children"s ¹
• Feverall Sprinkle Caps Junior Strength ¹
• Genapap Children"s Elixir ¹
• Genapap Children"s Tablets ¹
• Genapap Extra Strength Caplets ¹
• Genapap Extra Strength Tablets ¹
• Genapap, Infants" ¹
• Genapap Regular Strength Tablets ¹
• Genebs Extra Strength Caplets ¹
• Genebs Regular Strength Tablets ¹
• Genebs X-Tra ¹
• Liquiprin Children"s Elixir ¹
• Liquiprin Infants" Drops ¹
• Neopap ¹
• Oraphen-PD ¹
• Panadol, Children"s ¹
• Panadol, Infants" ¹
• Panadol Junior Strength Caplets ¹
• Panadol Maximum Strength Caplets ¹
• Panadol Maximum Strength Tablets ¹
• Phenaphen Caplets ¹
• Redutemp ¹
• Snaplets-FR ¹
• St. Joseph Aspirin-Free Fever Reducer for Children ¹
• Suppap-120 ¹
• Suppap-325 ¹
• Suppap-650 ¹
• Tapanol Extra Strength Caplets ¹
• Tapanol Extra Strength Tablets ¹
• Tempra ¹
• Tempra D.S ¹
• Tempra, Infants" ¹
• Tempra Syrup ¹
• Tylenol Arthritis Extended Relief
• Tylenol Children"s Chewable Tablets ¹
• Tylenol Children"s Elixir ¹
• Tylenol Children"s Suspension Liquid ¹
• Tylenol Extra-Strength Adult Liquid Pain Reliever ¹
• Tylenol Extra Strength Caplets ¹
• Tylenol Extra Strength Gelcaps ¹
• Tylenol Extra Strength Tablets ¹
• Tylenol Infants" Drops ¹
• Tylenol Infants" Suspension Drops ¹
• Tylenol Junior Strength Caplets ¹
• Tylenol Junior Strength Chewable Tablets ¹
• Tylenol Regular Strength Caplets ¹
• Tylenol Regular Strength Tablets ¹
• Valorin ¹
• Valorin Extra ¹

Some commonly used brand names are:

In Canada—

• Abenol ¹
• Actimol Chewable Tablets ¹
• Actimol Children"s Suspension ¹
• Actimol Infants" Suspension ¹
• Actimol Junior Strength Caplets ¹
• Anacin-3 ¹
• Anacin-3 Extra Strength ¹
• Apo-Acetaminophen ¹
• Atasol Caplets ¹
• Atasol Drops ¹
• Atasol Forte Caplets ¹
• Atasol Forte Tablets ¹
• Atasol Oral Solution ¹
• Atasol Tablets ¹
• Excedrin Caplets ²
• Excedrin Extra Strength Caplets ²
• Exdol ¹
• Exdol Strong ¹
• Panadol ¹
• Panadol Extra Strength ¹
• Robigesic ¹
• Rounox ¹
• Tempra Caplets ¹
• Tempra Chewable Tablets ¹
• Tempra Drops ¹
• Tempra Syrup ¹
• Tylenol Caplets ¹
• Tylenol Children"s Chewable Tablets ¹
• Tylenol Drops ¹
• Tylenol Elixir ¹
• Tylenol Gelcaps ¹
• Tylenol Junior Strength Caplets ¹
• Tylenol Tablets ¹

Other commonly used names are APAP and paracetamol .

Category

• Analgesic—Acetaminophen; Acetaminophen and Caffeine
• Antipyretic—Acetaminophen; Acetaminophen and Caffeine

Description

Acetaminophen is used to relieve pain and reduce fever. Unlike aspirin, it does not relieve the redness, stiffness, or swelling caused by rheumatoid arthritis. However, it may relieve the pain caused by mild forms of arthritis.

This medicine is available without a prescription; however, your medical doctor or dentist may have special instructions on the proper dose of acetaminophen for your medical condition.

Acetaminophen is available in the following dosage forms:

• Oral
• Acetaminophen
  • Capsules (U.S.)
  • Oral granules (in packets) (U.S.)
  • Oral liquid (drops) for babies (U.S. and Canada)
  • Oral liquid for children (U.S. and Canada)
  • Oral liquid for adults (U.S.)
  • Oral powders (in capsules) (U.S.)
  • Oral suspension (drops) for babies (U.S. and Canada)
  • Oral suspension (liquid) for children (U.S. and Canada)
  • Tablets (U.S. and Canada)
  • Chewable tablets (U.S. and Canada)
• Acetaminophen and Caffeine
  • Tablets (U.S. and Canada)

• Rectal
• Acetaminophen
  • Suppositories (U.S. and Canada)

Before Using This Medicine

If you are taking this medicine without a prescription, carefully read and follow any precautions on the label. For acetaminophen, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to acetaminophen or aspirin. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Although studies have not been done in pregnant women, acetaminophen has not been reported to cause birth defects or other problems.

Breast-feeding—Although acetaminophen passes into the breast milk in small amounts, it has not been reported to cause problems in nursing babies.

Children—This medicine has been tested in children and has not been shown to cause different side effects or problems than it does in adults. However, some children"s products containing acetaminophen also contain aspartame, which may be dangerous if it is given to children with phenylketonuria.

Older adults—Acetaminophen has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your health care professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other medical problems—The presence of other medical problems may affect the use of acetaminophen. Make sure you tell your doctor if you have any other medical problems, especially:

• Alcohol abuse or
• Kidney disease (severe) or
• Hepatitis or other liver disease—The chance of serious side effects may be increased

• Phenylketonuria—Some brands of acetaminophen contain aspartame, which can make your condition worse

Proper Use of This Medicine

Unless otherwise directed by your medical doctor or dentist :

• Do not take more of this medicine than is recommended on the package label . If too much is taken, liver and kidney damage may occur.
• Children up to 12 years of age should not take this medicine more than 5 times a day .

To use acetaminophen oral granules (e.g., Snaplets-FR):

• Just before the medicine is to be taken, open the number of packets needed for one dose. Mix the granules inside of the packets with a small amount of soft food, such as applesauce, ice cream, or jam. Eat the acetaminophen granules along with the food.

To use acetaminophen oral powders (e.g., Feverall Sprinkle Caps [Children"s or Junior Strength]):

• These capsules are not intended to be swallowed whole. Instead, just before the medicine is to be taken, open the number of capsules needed for one dose. Empty the powder from each capsule into 1 teaspoonful of water or other liquid. Drink the medicine along with the liquid. You may drink more liquid after taking the medicine. You may also mix the powder with a small amount of soft food, such as applesauce, ice cream, or jam. Eat the acetaminophen powder along with the food.

For patients using acetaminophen suppositories :

• If the suppository is too soft to insert, chill it in the refrigerator for 30 minutes or run cold water over it before removing the foil wrapper.
• To insert the suppository:
  • First remove the foil wrapper and moisten the suppository with cold water. Lie down on your side and use your finger to push the suppository well up into the rectum.

Dosing—The dose of acetaminophen will be different for different patients. Follow your doctor"s orders or the directions on the label . The following information includes only the average doses of acetaminophen. If your dose is different, do not change it unless your doctor tells you to.

The number of capsules, tablets, teaspoonfuls of oral solution or suspension that you take, the amount of oral granules or powders that you take, or the number of suppositories that you use, depends on the strength of the medicine. Also, the number of doses you use each day and the time allowed between doses depend on the strength of the medicine.

• For oral dosage forms (capsules, granules, powders, solution, suspension, or tablets) and rectal dosage forms (suppositories):
  • For pain or fever:
    • Adults and teenagers—325 or 500 milligrams (mg) every three or four hours, 650 mg every four to six hours, or 1000 mg every six hours as needed.The total dose should not be more than 4000 mg (for example, eight 500-mg tablets) a day.
    • Children—Acetaminophen dose is based on the child"s age.
      • Infants up to 3 months of age: 40 mg every four hours as needed.
      • Infants 4 to 12 months of age: 80 mg every four hours as needed.
      • Children 1 to 2 years of age: 120 mg every four hours as needed.
      • Children 2 to 4 years of age: 160 mg every four hours as needed.
      • Children 4 to 6 years of age: 240 mg every four hours as needed.
      • Children 6 to 9 years of age: 320 mg every four hours as needed.
      • Children 9 to 11 years of age: 320 to 400 mg every four hours as needed.
      • Children 11 to 12 years of age: 320 to 480 mg every four hours as needed.

Storage—To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store acetaminophen tablets (including caplets and gelcaps), capsules, or granules in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Keep the liquid and suppository forms of this medicine from freezing.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

Check with your medical doctor or dentist:

• If you are taking this medicine to relieve pain, including arthritis pain, and the pain lasts for more than 10 days for adults or 5 days for children or if the pain gets worse, new symptoms occur, or the painful area is red or swollen. These could be signs of a serious condition that needs medical or dental treatment.
• If you are taking this medicine to bring down a fever, and the fever lasts for more than 3 days or returns, the fever gets worse, new symptoms occur, or redness or swelling is present. These could be signs of a serious condition that needs treatment.
• If you are taking this medicine for a sore throat, and the sore throat is very painful, lasts for more than 2 days, or occurs together with or is followed by fever, headache, skin rash, nausea, or vomiting.

Check the labels of all prescription and nonprescription (over-the-counter [OTC]) medicines you now take. If any contain acetaminophen, check with your health care professional . Taking them together with this medicine may cause an overdose.

If you will be taking more than an occasional 1 or 2 doses of acetaminophen, do not drink alcoholic beverages . To do so may increase the chance of liver damage, especially if you drink large amounts of alcoholic beverages regularly, if you take more acetaminophen than is recommended on the package label, or if you take it regularly for a long time.

Taking certain other medicines together with acetaminophen may increase the chance of unwanted effects. The risk will depend on how much of each medicine you take every day, and on how long you take the medicines together. If your medical doctor or dentist directs you to take these medicines together on a regular basis, follow his or her directions carefully. However, do not take any of the following medicines together with acetaminophen for more than a few days unless your doctor has directed you to do so and is following your progress :

• Aspirin or other salicylates
• Diclofenac (e.g., Voltaren)
• Diflunisal (e.g., Dolobid)
• Etodolac (e.g., Lodine)
• Fenoprofen (e.g., Nalfon)
• Floctafenine (e.g., Idarac)
• Flurbiprofen, oral (e.g., Ansaid)
• Ibuprofen (e.g., Motrin)
• Indomethacin (e.g., Indocin)
• Ketoprofen (e.g., Orudis)
• Ketorolac (e.g., Toradol)
• Meclofenamate (e.g., Meclomen)
• Mefenamic acid (e.g., Ponstel)
• Nabumetone (e.g., Relafen)
• Naproxen (e.g., Naprosyn)
• Oxaprozin (e.g., Daypro)
• Phenylbutazone (e.g., Butazolidin)
• Piroxicam (e.g., Feldene)
• Sulindac (e.g., Clinoril)
• Tenoxicam (e.g., Apo-Tenoxicam)
• Tiaprofenic acid (e.g., Surgam)
• Tolmetin (e.g., Tolectin)

Acetaminophen may interfere with the results of some medical tests. Before you have any medical tests, tell the person in charge if you have taken acetaminophen within the past 3 or 4 days. If possible, it is best to call the laboratory where the test will be done about 4 days ahead of time, to find out whether this medicine may be taken during the 3 or 4 days before the test.

For diabetic patients :

• Acetaminophen may cause false results with some blood glucose (sugar) tests. If you notice any change in your test results, or if you have any questions about this possible problem, check with your health care professional. This is especially important if your diabetes is not well-controlled.

For patients taking one of the products that contain caffeine in addition to acetaminophen:

• Caffeine may interfere with the results of a test that uses adenosine (e.g., Adenocard) or dipyridamole (e.g., Persantine) to help find out how well your blood is flowing through certain blood vessels. Therefore, you should not have any caffeine for 8 to 12 hours before the test.

If you think that you or anyone else may have taken an overdose of acetaminophen, get emergency help at once, even if there are no signs of poisoning . Signs of severe poisoning may not appear for 2 to 4 days after the overdose is taken, but treatment to prevent liver damage or death must be started as soon as possible. Treatment started more than 24 hours after the overdose is taken may not be effective.

Side Effects of This Medicine

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Also, check with your doctor as soon as possible if any of the following side effects occur:

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

Revised: 11/07/2002

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