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

INDICATIONS AND USAGE

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

DOSAGE AND ADMINISTRATION

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

The usual adult dosage is:

	Single Doses (Range)	Maximum 24-Hour Dose
Codeine Phosphate	15 mg to 60 mg	360 mg
Acetaminophen	300 mg to 1,000 mg	4,000 mg

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. 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.

HOW SUPPLIED

TYLENOL^® with Codeine (acetaminophen and codeine phosphate) No. 3 Tablets contain acetaminophen 300 mg and codeine phosphate 30 mg. The tablets are white, round, flat-faced, beveled-edged tablet, imprinted "McNEIL" on one side and "TYLENOL CODEINE" and "3" on the other side.

TYLENOL^® with Codeine No. 4 Tablets contain acetaminophen 300 mg and codeine phosphate 60 mg. The tablets are white, round, flat-faced, beveled-edged tablet, imprinted "McNEIL" on one side and "TYLENOL CODEINE" and "4" on the other side.

TYLENOL^® with Codeine Tablets are supplied as follows:

TYLENOL^® with Codeine No. 3 bottle of 100 tablets – NDC 50458-513-60

TYLENOL^® with Codeine No. 3 bottle of 1000 tablets – NDC 50458-513-80

TYLENOL^® with Codeine No. 4 bottle of 100 tablets – NDC 50458-515-60

TYLENOL^® with Codeine No. 4 bottle of 500 tablets – NDC 50458-515-70

Store TYLENOL^® with Codeine Tablets at 20° to 25°C (68° to 77°F). (See USP Controlled Room Temperature.)

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

Manufactured by:
Janssen Ortho, LLC
Gurabo, Puerto Rico 00778

Manufactured for:
Janssen Pharmaceuticals, Inc.
Titusville, NJ 08560

10186602

Revised December 2011

© Janssen Pharmaceuticals, Inc. 2000