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

INDICATIONS

Fiorinal with Codeine is indicated for the relief of the symptom complex of tension (or muscle contraction) headache.

Evidence supporting the efficacy of Fiorinal with Codeine is derived from 2 multi-clinic trials that compared patients with tension headache randomly assigned to 4 parallel treatments: Fiorinal with Codeine, 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 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 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.

Rx only

Keep out of reach of children.

For all medical inquiries contact:
WATSON
Medical Communications
Parsippany, NJ 07054
800-272-5525

Distributed By:
Watson Pharma, Inc.
Parsippany, NJ 07054

Content Updated: May 2013

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