Acetaminophen / Codeine Phosphate

Indications

Acetaminophen and Codeine Phosphate Tablets, USP are indicated for the relief of mild to moderately severe pain.

Dosage and administration (summary)

Dosage should be adjusted according to severity of pain and response of the patient. The usual adult dosage is: Single Doses Maximum Range 24-Hour Dose Codeine Phosphate 15mg to 60mg 360 mg Acetaminophen 300 mg to 1000 mg 4000 mg The usual dose of codeine phosphate in children is 0.5 mg/kg. Doses may be repeated up to every 4 hours. The prescriber must determine the number of tablets per dose, and the maximum number of tablets per 24 hours, based upon the above dosage guidance. This information should be conveyed in the prescription. It should be kept in mind, however, that tolerance to codeine can develop with continued use and that the incidence of untoward effects is dose related.

Contraindications

Codeine-containing products are contraindicated for post-operative pain management in children who have undergone tonsillectomy and/or adenoidectomy. Acetaminophen and Codeine Phosphate Tablets should not be administered to patients who have previously exhibited hypersensitivity to codeine or acetaminophen.

Storage and supply

Acetaminophen and Codeine Phosphate Tablets, USP 300 mg /30 mg are white, round, flat, beveled edged tablets debossed “IP 33” on obverse and “3” on reverse. They are available as follows: Bottles of 20: NDC 63187-491-20 Bottles of 30: NDC 63187-491-30 Bottles of 60 : NDC 63187-491-60 Bottles of 90 : NDC 63187-491-90 Store Acetaminophen and Codeine …

Source: Acetaminophen And Codeine (Acetaminophen And Codeine) — US FDA prescribing information, 2021-01-01, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.