INDICATIONS
Fiorinal® with Codeine (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 Fiorinal® with Codeine (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: Fiorinal® with Codeine (Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, USP), codeine, Fiorinal® (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. Fiorinal® with Codeine (Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, USP) proved statistically significantly superior to each of its components (Fiorinal®, codeine) and to placebo on measures of pain relief.
Evidence supporting the efficacy and safety of Fiorinal® with Codeine (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
Fiorinal® with Codeine
(Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, USP)
Blue cap with a yellow body. Cap is imprinted twice with “FIORINAL” and “CODEINE” in red. Body is imprinted twice with “WATSON 956” in red.
Bottles of 100 are supplied with child-resistant closures. (NDC 52544-956-01)
Store and Dispense
Below 25°C (77°F); tight container. Protect from moisture.
Rx only
Watson Pharmaceuticals, Inc.
Corona, CA 92880 USA
Revised: January 2007
FIORNCOD01/07
S0107
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