acetaminophen (OTC)

Brand and Other Names:Tylenol, Tylenol Arthritis Pain, more...Tylenol Ext, Little Fevers Children's Fever/Pain Reliever, Little Fevers Infant Fever/Pain Reliever, PediaCare Single Dose Acetaminophen Fever Reducer/Pain Reliever
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet

  • 325mg
  • 500mg

caplet

  • 325mg
  • 500mg
  • 650mg

capsule

  • 500mg

gelcap/geltab

  • 500mg

caplet, extended-release

  • 650mg

tablet, chewable

  • 80mg

tablet, oral-disintegrating

  • 80mg
  • 160mg

oral solution/suspension

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

liquid oral

  • 500mg/5mL
  • 160mg/15mL
  • 500mg/15mL

syrup oral

  • 160mg5mL

elixir

  • 160mg/5mL
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Analgesia & Fever

immediate-release

  • Regular strength: 325-650 mg PO/PR q4hr PRN; 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 PO q6-8hr PRN; 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) PO q8hr PRN; 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 (ie, 500 mg/tab or cap): Not to exceed 3 g/day (6 tabs or caps); under supervision of healthcare professional, daily doses of up to 4 g/day may be used

Renal Impairment

Longer dosing intervals and reduced total dose may be warranted in patients with severe renal impairment (CrCl ≤30 mL/min)

Hepatic Impairment

Use with caution with any type of liver disease

Dosage Forms & Strengths

tablet

  • 325mg500mg

caplet

  • 325mg
  • 500mg
  • 650mg

capsule

  • 500mg

gelcap/geltab

  • 500mg

caplet, extended-release

  • 650mg

tablet, chewable

  • 80mg

tablet, oral-disintegrating

  • 80mg
  • 160mg

oral solution/suspension

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

liquid oral

  • 500mg/5mL
  • 160mg/15mL
  • 500mg/15mL

syrup oral

  • 160mg5mL

elixir

  • 160mg/5mL
more...

Pain & Fever Relief

Weight-based dosing

  • <12 years: 10-15 mg/kg/dose PO q4-6hr; not to exceed 5 doses/24hr 

Fixed dosing

  • <6 years: Ask a healthcare provider
  • 6-12 years: 325 mg PO q4-6hr; not to exceed 1.625 g/day for not more than 5 days unless directed by healthcare provider
  • >12 years
    • Regular strength: 650 mg q4-6hr; not to exceed 3.25 g/24hr; under supervision of healthcare professional, doses of up to 4 g/day may be used
    • Extra strength: 1000 mg q6hr; not to exceed 3 g/24hr; under supervision of healthcare professional, doses of up to 4 g/day may be used
    • Extended release: 1.3 g q8hr; not to exceed 3.9 g/24hr
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Interactions

Interaction Checker

and acetaminophen

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      Serious - Use Alternative

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            Adverse Effects

            Frequency Not Defined

            Angioedema

            Disorientation

            Dizziness

            Pruritic maculopapular rash

            Rash

            Hyperammonemia

            Stevens-Johnson syndrome

            Toxic epidermal necrolysis

            Urticaria

            Gastrointestinal hemorrhage

            Laryngeal edema

            Agranulocytosis

            Leukopenia

            Neutropenia

            Pancytopenia

            Thrombocytopenia

            Thrombocytopenic purpura

            Hepatotoxicity

            Liver failure

            Nephrotoxicity

            Pneumonitis

            Anaphylactoid

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            Warnings

            Contraindications

            Hypersensitivity

            Severe active liver disease

            Cautions

            Acetaminophen is available in many dosage forms and products, check label carefully to avoid overdose

            Repeated administration in patients with anemia or cardiac, pulmonary, or renal disease

            Risk of hepatotoxicity is higher in alcoholics, chronic high dose, or use of more than one acetaminophen-containing product

            Use with 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

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            Pregnancy & Lactation

            Pregnancy Category: B

            Crosses placenta, safe to use in all stages of pregnancy short term

            Lactation: Excreted in breast milk; compatible with breastfeeding

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Acts on hypothalamus to produce antipyresis

            May work peripherally to block pain impulse generation; may also inhibit prostaglandin synthesis in CNS

            Pharmacokinetics

            Peak Plasma Time: 10-60 min (PO immediate-release); 60-120 min (PO extended-release); 6 hr (PO 500 mg, conventional tablet); 8 hr (PO 650 mg, extended-release tablet)

            Peak Plasma Concentration: 2.1 mcg/mL (PO 500 mg, conventional tablet); 1.8 mcg/mL (PO 650 mg, extended-release tablet)

            Onset: 1 hr

            Distribution: 1 L/kg

            Protein Bound: 10 to 25%

            Metabolism: Liver (microsomal enzyme systems); conjugation (glucuronic/sulfuric acid)

            Metabolites: N-acetyl-p-benzoquinoneimine, N-acetylimidoquinone, NAPQI; further metabolized via conjugation with glutathione

            Half-life elimination: 1.25-3 hr (adolescents); 2-5 hr (children); 4 hr (infants); 7 hr (neonates); 2-3 hr (adults)

            Excretion: urine (principally as acetaminophen glucuronide with acetaminophen sulfate/mercaptate)

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            Images

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