Fiorinal with Codeine
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Fiorinal with Codeine
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.
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
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.
Watson Pharmaceuticals, Inc. Corona, CA 92880, USA. Revised: January 2007. FDA Rev date: 4/6/2002
Last reviewed on RxList: 4/11/2008
This monograph has been modified to include the generic and brand name in many instances.
Additional Fiorinal with Codeine Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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