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,USP 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, USP; 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, USP 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.
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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
Keep out of reach of children.
For all medical inquiries contact:
ACTAVIS
Medical Communications
Parsippany, NJ 07054
1-800-272-5525
Distributed By:
Actavis Pharma, Inc.
Parsippany, NJ 07054 USA
Content Updated: February 2014
191097-2
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