July 26, 2016
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Fioricet

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Fioricet

Indications
Dosage
How Supplied

INDICATIONS

Esgic® Capsules (butalbital, acetaminophen and caffeine capsules USP 50 mg/325 mg/40 mg) are indicated for the relief of the symptom complex of tension (or muscle contraction) headache.

Evidence supporting the efficacy and safety of this combination product 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 two capsules every four 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

Esgic® Capsules, containing butalbital 50 mg (WARNING: May be habit-forming), acetaminophen 325 mg and caffeine 40 mg, are opaque white, body and cap, and are imprinted with logo on one side and “535- 12” in kelly green ink. They are supplied in bottles of 100 capsules, NDC 0535-0012-01.

Storage

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Dispense in a tight, light-resistant container with a child-resistant closure.

Manufactured by: MIKART, INC, Atlanta, GA 30318. For: GILBERT LABORATORIES, Affiliate of Forest Pharmaceuticals, Inc., St. Louis, Missouri 63045. Revised: Oct 2013

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 5/6/2016

Indications
Dosage
How Supplied

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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