INDICATIONS
Fiorinal® with Codeine (butalbital, aspirin, caffeine, and codeine phosphate) 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) 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), codeine, Fiorinal® (butalbital, aspirin, and caffeine), 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) 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) in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because codeine and butalbital are habitforming and potentially abusable.
|
HOW SUPPLIED
Fiorinal ® with Codeine
(butalbital, aspirin, caffeine, and codeine phosphate)
Capsules, USP
Imprinted twice with “FIORINAL” and “CODEINE” on one half, and imprinted twice with “WATSON 956” on other half, color is blue and yellow.
Bottles of 100 (NDC 52544-956-01)
Store and Dispense
Below 25°C (77°F); tight container. Protect from moisture.
*Levophed is a registered Trademark of Sanofi Winthrop Pharmaceuticals.
**Trademark of Medical Economics Company, Inc.
Manufactured for:
Watson Pharma, Inc.
A subsidiary of Watson Pharmaceuticals, Inc.
Corona, CA 92880 USA
Manufactured by:
Novartis Pharmaceuticals Corporation
Suffern, New York 10901
REV: APRIL 2003
PRINTED IN USA
T2003-32
89020101
|
