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Acetaminophen; Codeine Indications and Dosage


  • arthralgia
  • bone pain
  • cough
  • dental pain
  • headache
  • migraine
  • mild pain
  • moderate pain
  • myalgia

non-FDA-approved indication

Acetaminophen; Codeine Indications and Dosage

For the treatment of mild pain to moderate pain including the relief of dental pain (e.g., toothache), headache , migraine , back pain , bone pain , arthralgia and myalgia :

Oral dosage (tablets or capsules):
Adults: 1 - 2 tablets PO every 4 hours as needed. Maximum single dose of codeine is 60 mg/dose. Maximum dose of acetaminophen is 4 g/day.

Children: 0.5 - 1 mg codeine/kg PO every 4 - 6 hours. Dosage should be titrated to appropriate analgesic effect. Maximum acetaminophen dose is 75 mg/kg/day PO or 4 g/day PO, whichever is less.

Oral dosage (elixir or suspension):
Adults and children >= 12 years: 15 ml PO every 4 hours as needed. Maximum single dose of codeine is 60 mg/dose. Maximum dose of acetaminophen is 4 g/day.

Children 7 - 11 years: 10 ml PO three to four times per day as needed. Maximum acetaminophen dose is 75 mg/kg/day PO or 4 g/day PO, whichever is less.

Children 4 - 6 years: 5 ml PO three to four times per day as needed. Maximum acetaminophen dose is 75 mg/kg/day PO or 4 g/day PO, whichever is less.

Children >= 3 years: Dosage not established.

For the treatment of non-productive cough :
Oral dosage:

Adults: 10 - 20 mg codeine PO every 4 - 6 hours as needed. Maximum codeine dose should not exceed 120 mg/24 hours when used as an antitussive and maximum acetaminophen dose is 4 g/day.

Children: 1 - 1.5 mg/kg/day codeine PO in divided doses every 4 - 6 hours as needed. Maximum acetaminophen dose is 75 mg/kg/day PO or 4 g/day PO, whichever is less. Alternatively, children 2 - 5 years of age can receive 2.5 - 5 mg codeine PO every 4 - 6 hours as needed (maximum codeine dose 30 mg/day when used as an antitussive) and children 6 - 12 years of age can receive 5 - 10 mg codeine PO every 4 - 6 hours as needed (maximum codeine dose 60 mg/day when used as an antitussive).

Maximum Dosage Limits:
NOTE: For combination products containing acetaminophen, total daily intake of acetaminophen from all sources should be considered and may be the dose-limiting consideration for acetaminophen; codeine products.


  • Adults: Acetaminophen 4 g/day PO; codeine 60 mg/dose PO; some clinicians have recommended the following maximum dosages: for pain, codeine 360 mg/24 hours PO; as an antitussive, codeine 120 mg/day PO.
  • Elderly: Acetaminophen 4 g/day PO; codeine 60 mg/dose PO; some clinicians have recommended the following maximum dosages: for pain, codeine 360 mg/24 hours PO; as an antitussive, codeine 120 mg/day PO.
  • Adolescents: Acetaminophen 4 g/day PO; codeine 60 mg/dose PO; some clinicians have recommended the following maximum dosages: for pain, codeine 360 mg/24 hours PO; as an antitussive, codeine 120 mg/day PO.
  • Children 6 - 12 years: Acetaminophen 75 mg/kg/day PO or 4 g/day PO, whichever is less; codeine 60 mg/dose PO; some clinicians have recommended a maximum dosage for codeine as an antitussive of 60 mg/day PO.
  • Children < 5 years: Acetaminophen 75 mg/kg/day PO or 4 g/day PO, whichever is less; as an antitussive, some clinicians have recommended a maximum dosage for codeine as an antitussive of 30 mg/day PO.

Patients with hepatic impairment:
Dosage should be modified depending upon the clinical response and degree of hepatic impairment. No quantitative recommendations are available.

Patients with renal impairment:
Dosage should be modified depending upon the clinical response and degree of renal impairment. No quantitative recommendations are available.

non-FDA approved indication

[ Last revised: 10/29/2003 4:55:00 PM ]

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