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

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. 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.

TYLENOL® with Codeine (acetaminophen and codeine phosphate) tablets: are white, round, flat-faced, beveled edged tablets imprinted “McNEIL,” on one side and “TYLENOL CODEINE” and either “3” or “4” on the other side and are supplied as follows: No. 3 – NDC 0045-0513-60 bottles of 100, NDC 0045-0513-80 bottles of 1000, No. 4 – NDC 0045-0515-60 bottles of 100, NDC 0045-0515-70 bottles of 500.

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

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

OMP DIVISION. ORTHO-McNEIL PHARMACEUTICAL, INC. Raritan, New Jersey 08869. Revised October 2004. FDA rev date:

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