Butalbital, Aspirin, Caffeine, and Codeine (Codeine Phosphate / Butalbital / Caffeine / Aspirin) - Indications and Dosage

INDICATIONS

Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, USP is indicated for the relief of the symptom complex of tension (or muscle contraction) headache.

Evidence supporting the efficacy of butalbital, aspirin, caffeine, and codeine phosphate capsules is derived from 2 multi-clinic trials that compared patients with tension headache randomly assigned to 4 parallel treatments: butalbital, aspirin, caffeine, and codeine phosphate capsules; codeine; Butalbital, Aspirin, and Caffeine Capsules, USP; and placebo. Response was assessed over the course of the first 4 hours of each of 2 distinct headaches, separated by at least 24 hours. Butalbital, aspirin, caffeine, and codeine phosphate capsules proved statistically significantly superior to each of its components (Butalbital, Aspirin, and Caffeine Capsules, USP and codeine) and to placebo on measures of pain relief.

Evidence supporting the efficacy and safety of Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, USP in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because codeine and butalbital are habit-forming and potentially abusable.

DOSAGE AND ADMINISTRATION

One or 2 capsules every 4 hours. Total daily dosage should not exceed 6 capsules.

Extended and repeated use of this product is not recommended because of the potential for physical dependence.

HOW SUPPLIED

Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, USP
Blue cap with a yellow body. Cap is imprinted with “WATSON” in red. Body is imprinted with “3546” in red. Supplied in bottles of 100 and 500. Bottles of 100 are supplied with child-resistant closures.

Store and Dispense

Below 25°C (77°F); tight container. Protect from moisture.

Rx only

Watson Laboratories, Inc.
Corona, CA 92880 USA

Revised: January 2007

BASPCC01/07
S0107