Acetaminophen

Acetaminophen is an analgesic used to temporarily relieve minor aches and pains due to headache, muscular aches, backache, minor pain of arthritis, the common cold, toothache, and premenstrual and menstrual cramps. Acetaminophen is also used to temporarily reduce fever.

• Acetaminophen is available under the following different brand names: Tylenol, Tylenol Arthritis Pain, Tylenol Ext, Little Fevers Children's Fever/Pain Reliever, Little Fevers Infant Fever/Pain Reliever, and PediaCare Single Dose Acetaminophen Fever Reducer/Pain Reliever.

Adult Dosage Forms & Strengths

Tablets

• 325 mg
• 500 mg

Caplets

• 325 mg
• 500 mg
• 650 mg

Capsules

• 500 mg

Gelcaps/Geltabs

• 500 mg

Caplets, Extended Release

• 650 mg

Tablets, Chewable

• 80 mg

Oral solution/suspension

• 160 mg/5 mL
• 80mg/0.8mL (oral drops)

Liquid Oral

• 500mg/5mL
• 160mg/15mL
• 500mg/15mL

Oral Syrup

• 160mg/5mL

Elixir

• 160mg/5mL

Immediate release

• Regular strength: 325-650 mg orally/rectally once every 4 hours as needed; not to exceed 3250 mg/day; under supervision of healthcare professional, daily doses of up to 4 g/day may be used
• Extra Strength: 1000 mg orally once every 6-8 hours as needed; not to exceed 3000 mg/day; under supervision of healthcare professional, daily doses of up to 4 g/day may be used

Extended-release

• 2 capsules (1300 mg) orally once every 8 hours as needed; not to exceed 3.9 g/day

Maximum dose

• Acetaminophen containing products: Not to exceed a cumulative dose of 3.25 g/day of acetaminophen; under supervision of healthcare professional, daily doses of up to 4 g/day may be used
• Tylenol Extra-Strength (i.e., 500 mg/tab or cap): Not to exceed 3 g/day (6 tabs or caps); under supervision of a healthcare professional, daily doses of up to 4 g/day may be used

Longer dosing intervals and the reduced total dose may be warranted in patients with severe renal impairment (CrCl less than or equal to 30 mL/min)

Use caution with any type of liver disease.

Pediatric Pain & Fever Relief

Weight-based dosing

• Children under 12 years: 10-15 mg/kg/dose taken orally once every 4-6 hours; not to exceed 5 doses in 24 hours

Fixed dosing

• Children under 6 years: Ask a healthcare provider
• Children 6-12 years: 325 mg orally once every 4-6 hours; not to exceed 1.625 g/day for not more than 5 days unless directed by a healthcare provider
• Children under 12 years and older:
  • Regular strength: 650 mg once every 4-6 hours; not to exceed 3.25 g in 24 hours; under supervision of healthcare professional, doses of up to 4 g/day may be used
  • Extra strength: 1000 mg once every 6 hours; not to exceed 3 g in 24 hours; under supervision of healthcare professional, doses of up to 4 g/day may be used
  • Extended-release: 1.3 g once every 8 hours; not to exceed 3.9 g in 24 hours

Side effects of acetaminophen include:

• Skin swelling (angioedema)
• Disorientation
• Dizziness
• Rash (may itch)
• Hives
• Low levels of red blood cells, white blood cells, and/or platelets
• Shortness of breath/cough

Serious side effects of acetaminophen include:

• Toxic epidermal necrolysis
• Severe allergic reaction (anaphylaxis)
• Liver failure
• Stevens-Johnson syndrome
• Gastrointestinal hemorrhage
• Laryngeal edema
• Kidney toxicity
• Liver toxicity/liver failure
• Hyperammonemia
• Agranulocytosis
• Low white blood cell count (leukopenia, neutropenia)
• Low platelet count (thrombocytopenia)
• Low red and white blood cell count and low platelet count (pancytopenia)

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• There are no severe interactions with acetaminophen and other drugs.
• There are no serious interactions with acetaminophen and other drugs.
• Moderate Interactions of acetaminophen include:
  • axitinib
  • busulfan
  • daclizumab
  • dapsone topical
  • eltrombopag
  • exenatide injectable solution
  • exenatide injectable suspension
  • flibanserin
  • imatinib
  • isoniazid
  • ivacaftor
  • lixisenatide
  • lomitapide
  • mipomersen
  • tetracaine
  • warfarin
• Acetaminophen has mild interactions with at least 55 different drugs.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. Check with your physician if you have health questions or concerns.

Warnings

This medication contains acetaminophen. Do not take Tylenol, Tylenol Arthritis Pain, Tylenol Ext, Little Fevers Children's Fever/Pain Reliever, Little Fevers Infant Fever/Pain Reliever, or PediaCare Single Dose Acetaminophen Fever Reducer/Pain Reliever if you are allergic to acetaminophen or any ingredients contained in this drug.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

Contraindications

Hypersensitivity

Effects of Drug Abuse

There are no effects of drug abuse with the use of acetaminophen.

Short-term Effects

See “What Are Side Effects Associated with Using Acetaminophen?”

Long-term Effects

• The risk of hepatotoxicity is higher in chronic high dose
• See “What Are Side Effects Associated with Using Acetaminophen?”

Cautions

• Acetaminophen is available in many dosage forms and products, check labels carefully to avoid overdose.
• Repeated administration in patients with anemia or cardiac, pulmonary, or renal disease.
• The risk of hepatotoxicity is higher in alcoholics, chronic high dose, or use of more than one acetaminophen-containing product.
• Use caution in patients with G6PD deficiency.
• Use caution in patients with chronic malnutrition.
• Risk for rare, but serious skin reactions that can be fatal; these reactions include Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP); symptoms may include skin redness, blisters, and rash.

Pregnancy and Lactation

• Acetaminophen may be acceptable to use during pregnancy. Either animal studies show no risk but human studies are not available or animal studies showed minor risks and human studies are done and showed no risk. Acetaminophen crosses the placenta; it is safe to use in all stages of pregnancy short term.
• Acetaminophen is excreted in breast milk; it is compatible with breastfeeding.