Tylenol with Codeine (Codeine / Acetaminophen) - Indications and Dosage

INDICATIONS AND USAGE

TYLENOL with Codeine tablets (acetaminophen and codeine phosphate tablets) are indicated for the relief of mild to moderately severe pain.

TYLENOL with Codeine elixir (acetaminophen and codeine phosphate oral solution USP) is indicated for the relief of mild to moderate pain.

DOSAGE AND ADMINISTRATION

Dosage should be adjusted according to severity of pain and response of the patient.

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. Adult doses of codeine higher than 60 mg fail to give commensurate relief of pain but merely prolong analgesia and are associated with an appreciably increased incidence of undesirable side effects. Equivalently high doses in children would have similar effects.

The usual adult dosage for tablets is:

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.

For children, the dose of codeine phosphate is 0.5 mg/kg.

TYLENOL with Codeine elixir (acetaminophen and codeine phosphate oral solution USP) contains 120 mg of acetaminophen and 12 mg of codeine phosphate/5 mL and is given orally.

HOW SUPPLIED

TYLENOL with Codeine tablets (acetaminophen and codeine phosphate tablets): (round, white, imprinted "McNEIL," "TYLENOL CODEINE" and either "3" or "4"): No. 3--NDC 0045-0513-60 bottles of 100, NDC 0045-0513-70 bottles of 500, NDC 0045-0513-80 bottles of 1000, NDC 0045-0513-72 unit dose (20 × 25); No. 4--NDC 0045-0515-60 bottles of 100, NDC 0045-0515-70 bottles of 500.

TYLENOL with Codeine elixir (acetaminophen and codeine phosphate oral solution USP) contains 120 mg acetaminophen and 12 mg codeine phosphate/5 mL (colored amber, cherry flavored) -- NDC 0045-0508-16, bottles of 1 pint.

Store TYLENOL with Codeine tablets at controlled room temperature (15-30°C, 59-86°F).

Store TYLENOL with Codeine elixir at controlled room temperature (15-30°C, 59-86°F). Protect from light. Do not refrigerate. Do not freeze.

Dispense in tight, light-resistant container as defined in the official compendium.

OMP DIVISION

ORTHO-MCNEIL

PHARMACEUTICAL, INC.

RARITAN, NEW JERSEY 08869

633-10-057-3 Revised July 2000

© OMP 2000