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Fioricet Indications, Dosage, Storage, Stability - Butalbital, Acetaminophen and Caffeine

Fioricet Indications, Dosage, Storage, Stability - Butalbital, Acetaminophen and Caffeine

INDICATIONS

Fioricet® (Butalbital, Acetaminophen, and Caffeine Tablets) is 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 2 tablets every 4 hours as needed. Total daily dosage should not exceed 6 tablets.

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

HOW SUPPLIED

Floricet ® (Butalbital, Acetaminophen, and Caffeine Tablets, USP)

Containing 50 mg butalbital, 325 mg acetaminophen, and 40 mg caffeine. Available as light-blue, round compressed tablets, engraved “FIORICET” on one side, three-head profile on other side.

Bottles of 100 (NDC 0078-0084-05) and 500 (NDC 0078-0084-08).
SandoPak® (unit-dose) packages of 100, 10 blister strips of 10 tablets (NDC 0078-0084-06).

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

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