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FIORICET

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

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Description

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Fioricet with Codeine: (butalbital, acetaminophen, caffeine, and also codeine phosphate) Capsules

DESCRIPTION
Fioricet with Codeine is supplied in capsule form for oral administration.

Each capsule contains:

Butalbital, USP ………………. 50 mg
Acetaminophen, USP ……………….300 mg
Caffeine, USP ……………….40 mg, also
Codeine Phosphate, USP ……………….30 mg

Active Ingredients: Butalbital, USP, Caffeine, USP, Acetaminophen, USP, and also Codeine Phosphate, USP.

Inactive Ingredients: FD&C blue #1, FD&C yellow #6, FD&C red #40, gelatin, microcrystalline cellulose, stearic acid, sodium lauryl sulfate, talc, and also titanium dioxide

INDICATIONS

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

Evidence supporting the efficacy and also safety of Fioricet 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.

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DOSAGE AND ADMINISTRATION

One or 2 capsules every 4 hours. The total daily dosage should not exceed 6 capsules.

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

HOW SUPPLIED

Fioricet with Codeine Capsules 50 mg/300 mg/40 mg/30 mg with a gray opaque body and also a navy blue opaque cap. Cap is imprinted with this medicine and “CODEINE” in blue and the body is imprinted with the four-head profile in red.

Bottles of 100 (NDC 52544-082-01)

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

Therefore, always dispense in a tight container.

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