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 ReliefFormula 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 torelieve pain and reduce fever. Unlike aspirin, it does not relieve the redness,stiffness, or swelling caused by rheumatoid arthritis. However, it may relievethe pain caused by mild forms of arthritis.

This medicine is available without a prescription; however, your medicaldoctor or dentist may have special instructions on the proper dose of acetaminophenfor 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 medicinewithout 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 orallergic reaction to acetaminophen or aspirin. Also tell your health careprofessional 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 milkin small amounts, it has not been reported to cause problems in nursing babies.

Children?This medicine has been tested in children and hasnot been shown to cause different side effects or problems than it does inadults. However, some children's products containing acetaminophen also containaspartame, which may be dangerous if it is given to children with phenylketonuria.

Older adults?Acetaminophen has been tested and has not been shownto cause different side effects or problems in older people than it does inyounger adults.

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

Other medical problems?The presence of other medicalproblems may affect the use of acetaminophen. Make sure you tell your doctorif you have any other medical problems, especially:

• Alcohol abuse or
• Kidney disease (severe) or
• Hepatitis or other liver disease?The chance of serious sideeffects 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 recommendedon the package label. If too much is taken, liver and kidney damagemay occur.
• Children up to 12 years of age should not takethis 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 packetsneeded for one dose. Mix the granules inside of the packets with a small amountof soft food, such as applesauce, ice cream, or jam. Eat the acetaminophengranules along with the food.

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

• These capsules are not intended to be swallowed whole. Instead, justbefore the medicine is to be taken, open the number of capsules needed forone dose. Empty the powder from each capsule into 1 teaspoonful of water orother liquid. Drink the medicine along with the liquid. You may drink moreliquid after taking the medicine. You may also mix the powder with a smallamount of soft food, such as applesauce, ice cream, or jam. Eat the acetaminophenpowder along with the food.

For patients using acetaminophen suppositories:

• If the suppository is too soft to insert, chill it in the refrigeratorfor 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 coldwater. Lie down on your side and use your finger to push the suppository wellup into the rectum.

Dosing?The dose of acetaminophen will be differentfor different patients. Follow your doctor's orders orthe directions on the label. The following information includes onlythe 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 suspensionthat you take, the amount of oral granules or powders that you take, or thenumber 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 dosesdepend 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 threeor four hours, 650 mg every four to six hours, or 1000 mg every six hoursas needed.The total dose should not be more than 4000 mg (for example, eight500-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 asneeded.
      • Children 11 to 12 years of age: 320 to 480 mg every four hours asneeded.

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 otherdamp 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 surethat 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 arthritispain, and the pain lasts for more than 10 days for adults or 5 days for childrenor if the pain gets worse, new symptoms occur, or the painful area is redor swollen. These could be signs of a serious condition that needs medicalor dental treatment.
• If you are taking this medicine to bring down a fever, and the feverlasts for more than 3 days or returns, the fever gets worse, new symptomsoccur, or redness or swelling is present. These could be signs of a seriouscondition that needs treatment.
• If you are taking this medicine for a sore throat, and the sore throatis very painful, lasts for more than 2 days, or occurs together with or isfollowed 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 withthis 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 mayincrease the chance of liver damage, especially if you drink large amountsof alcoholic beverages regularly, if you take more acetaminophen than is recommendedon the package label, or if you take it regularly for a long time.

Taking certain other medicines together with acetaminophen may increasethe chance of unwanted effects. The risk will depend on how much of each medicineyou take every day, and on how long you take the medicines together. If yourmedical doctor or dentist directs you to take these medicines together ona regular basis, follow his or her directions carefully. However, do not take any of the following medicines together with acetaminophen formore than a few days unless your doctor has directed you to do so and is followingyour 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. Beforeyou have any medical tests, tell the person in charge if you have taken acetaminophenwithin the past 3 or 4 days. If possible, it is best to call the laboratorywhere the test will be done about 4 days ahead of time, to find out whetherthis 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 questionsabout this possible problem, check with your health care professional. Thisis 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 howwell your blood is flowing through certain blood vessels. Therefore, you shouldnot have any caffeine for 8 to 12 hours before the test.

If you think that you or anyone else may have takenan overdose of acetaminophen, get emergency help at once, even if there areno signs of poisoning. Signs of severe poisoning may not appear for2 to 4 days after the overdose is taken, but treatment to prevent liver damageor death must be started as soon as possible. Treatment started more than24 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 sideeffects may occur, if they do occur they may need medical attention.

Check with your doctorimmediately if any of the following 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 stomach area

Also, checkwith your doctor as soon as possible if any of the following side effectsoccur:

Rare

Bloody or black, tarry stools; bloodyor cloudy urine; fever with or without chills (notpresent before treatment and not caused by the condition being treated); pain in lower back and/or side (severe and/or sharp); pinpoint red spots on skin; skin rash,hives, or itching; sores, ulcers, or white spotson lips or in mouth; sore throat (not present beforetreatment and not caused by the condition being treated); sudden decrease in amount of urine; unusual bleedingor bruising; unusual tiredness or weakness

Other side effects not listed abovemay also occur in some patients. If you notice any other effects, check withyour doctor.