Drug Info: A: Acetaminophen (Systemic)

In the U.S.—

In Canada—

Other commonly used names are APAP; paracetamol.

• Analgesic --Acetaminophen ; Acetaminophenand Caffeine
• Antipyretic --Acetaminophen; Acetaminophenand Caffeine

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 mayrelieve the pain caused by mild forms of arthritis.

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

Acetaminophen is available in the following dosageforms:

• 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. andCanada)
  • Oral suspension (liquid) for children (U.S. andCanada)
  • 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)

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

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

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

Breast-feeding—Although acetaminophenpasses into the breast milk in small amounts, it has not beenreported to cause problems in nursing babies.

Children—This medicine has been testedin children and has not been shown to cause different sideeffects or problems than it does in adults. However, somechildren's products containing acetaminophen also containaspartame, which may be dangerous if it is given to childrenwith phenylketonuria.

Older adults—Acetaminophen has beentested and has not been shown to cause different side effectsor problems in older people than it does in youngeradults.

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

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

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

Unless otherwise directed by your medical doctor ordentist :

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

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

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

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

• These capsules are not intended to be swallowed whole.Instead, just before the medicine is to be taken, open thenumber of capsules needed for one dose. Empty the powderfrom each capsule into 1 teaspoonful of water or otherliquid. Drink the medicine along with the liquid. You maydrink more liquid after taking the medicine. You may alsomix the powder with a small amount of soft food, such asapplesauce, ice cream, or jam. Eat the acetaminophen powderalong with the food.

For patients using acetaminophen suppositories:

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

Dosing—

The dose of acetaminophen will be different for differentpatients. Follow your doctor's orders or the directions on thelabel. The following information includes only theaverage doses of acetaminophen. If your dose is different, do not change it unlessyour doctor tells you to.

The number of capsules, tablets, teaspoonfuls of oralsolution or suspension that you take, the amount of oralgranules or powders that you take, or the number ofsuppositories that you use, depends on the strength of themedicine. Also, the number of doses you use each day and thetime allowed between doses depend on the strength of themedicine.

• 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 tosix hours, or 1000 mg every six hours as needed.Thetotal dose should not be more than 4000 mg (forexample, eight 500–mg tablets) a day.
    • Children—Acetaminophen dose is based on thechild's age.
      • Infants up to 3 months of age: 40 mg every fourhours as needed.
      • Infants 4 to 12 months of age: 80 mg every fourhours as needed.
      • Children 1 to 2 years of age: 120 mg every fourhours as needed.
      • Children 2 to 4 years of age: 160 mg every fourhours as needed.
      • Children 4 to 6 years of age: 240 mg every fourhours as needed.
      • Children 6 to 9 years of age: 320 mg every fourhours as needed.
      • Children 9 to 11 years of age: 320 to 400 mgevery four hours as needed.
      • Children 11 to 12 years of age: 320 to 480 mgevery 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 capletsand gelcaps), capsules, or granules in the bathroom, nearthe kitchen sink, or in other damp places. Heat or moisturemay cause the medicine to break down.
• Keep the liquid and suppository forms of this medicinefrom freezing.
• Do not keep outdated medicine or medicine no longerneeded. Be sure that any discarded medicine is out of thereach of children.

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 than10 days for adults or 5 days for children or if the paingets worse, new symptoms occur, or the painful area is redor swollen. These could be signs of a serious conditionthat 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, thefever gets worse, new symptoms occur, or redness orswelling is present. These could be signs of a seriouscondition that needs treatment.
• If you are taking this medicine for a sore throat, andthe sore throat is very painful, lasts for more than 2days, 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 anycontain acetaminophen, check with your health careprofessional. Taking them together with this medicinemay cause an overdose.

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

Taking certain other medicines together with acetaminophenmay increase the chance of unwanted effects. The risk willdepend on how much of each medicine you take every day, andon how long you take the medicines together. If your medicaldoctor or dentist directs you to take these medicinestogether on a regular basis, follow his or her directionscarefully. However, do not take any of the following medicines together withacetaminophen for more than a few days unless your doctor hasdirected you to do so and is following yourprogress:

• 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 somemedical tests. Before you have any medical tests, tell theperson in charge if you have taken acetaminophen within thepast 3 or 4 days. If possible, it is best to call thelaboratory where the test will be done about 4 days ahead oftime, to find out whether this medicine may be taken duringthe 3 or 4 days before the test.

For diabetic patients:

• Acetaminophen may cause false results with some bloodglucose (sugar) tests. If you notice any change in yourtest results, or if you have any questions about thispossible problem, check with your health care professional.This is especially important if your diabetes is notwell-controlled.

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

• Caffeine may interfere with the results of a test thatuses adenosine (e.g., Adenocard) or dipyridamole (e.g.,Persantine) to help find out how well your blood is flowingthrough certain blood vessels. Therefore, you should nothave any caffeine for 8 to 12 hours before the test.

If you think that you or anyone else may have taken anoverdose of acetaminophen, get emergency help at once, evenif there are no signs of poisoning. Signs of severepoisoning may not appear for 2 to 4 days after the overdoseis taken, but treatment to prevent liver damage or death mustbe started as soon as possible. Treatment started more than24 hours after the overdose is taken may not beeffective.

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

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

• Rare
  • Yellow eyes or skin
  
  

• Symptoms of overdose
  • Diarrhea; increased sweating; loss of appetite;nausea or vomiting ; stomach cramps or pain; swelling,pain, or tenderness in the upper abdomen or stomacharea
  
  

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

• Rare
  • Bloody or black, tarry stools; bloody or cloudyurine; fever with or without chills (not present beforetreatment and not caused by the condition beingtreated); pain in lower back and/or side (severe and/orsharp); pinpoint red spots on skin; skin rash, hives,or itching; sores, ulcers, or white spots on lips or inmouth; sore throat (not present before treatment andnot caused by the condition being treated); suddendecrease in amount of urine; unusual bleeding orbruising; unusual tiredness or weakness
  
  

Other side effects not listed above may also occur in somepatients. If you notice any other effects, check with yourdoctor.