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

INDICATIONS AND USAGE

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 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. 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

Acetaminophen and Codeine Phosphate Tablets 300 mg/15 mg are white, round, flat-faced, beveled edge, scored (bisect bar) tablets, debossed "2063" and "V" on one side and debossed "2" on the reverse side. They are supplied in bottles of 100's, 500's and 1000's.

Dispense in a tight, light resistant container as defined in the USP/NF.

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Manufactured for:
QUALITEST PHARMACEUTICALS
Huntsville, AL 35811

8182437
R11/07-R2