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Fioricet (Butalbital / Acetaminophen / Caffeine) - Indications and Dosage

 
 



INDICATIONS AND USAGE

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

Evidence supporting the efficacy and safety of Fioricet in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because butalbital is habit-forming and potentially abusable.

DOSAGE AND ADMINISTRATION

One or 2 tablets every 4 hours as needed. Total daily dosage should not exceed 6 tablets.

Extended and repeated use of Fioricet is not recommended because of the potential for physical dependence.

HOW SUPPLIED

Fioricet Tablets

Containing 50 mg butalbital, 325 mg acetaminophen, and 40 mg caffeine.

Available as light-blue, speckled, round uncoated tablets, engraved "FIORICET" on one side, and a three-head profile

 on other side. Bottles of 100 (NDC 52544-957-01) and 500 (NDC 52544-957-05). Bottles of 100 are supplied with child-resistant closures.

Store below 30°C (86°F); dispense in a tight container.

Keep out of reach of children.

Rx only

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

Distributed By:
Actavis Pharma, Inc.
Parsippany, NJ 07054 USA

Revised: April 2014

174240-4

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