Fiorinal (ASA – Caffeine – Butalbital)

FIORINAL®

Novartis Pharmaceuticals

ASA – Caffeine – Butalbital

Analgesic – Sedative

Indications And Clinical Uses: For tension (or muscle contraction) headache and conditions where a simultaneous sedative and analgesic action is required, such as mixed migraine headaches, menstrual and postpartum tension and pain.

Contraindications, Precautions and Adverse Effects: See Fiorinal-C monograph.

A possible association between Reye’s syndrome and the use of salicylates has been suggested but not established. Reye’s syndrome has also occurred in many patients not exposed to salicylates. However, caution is advised when prescribing salicylate-containing medications for children, teenagers and young adults with influenza or chickenpox.

Note: Fiorinal products have the potential for being abused and should be avoided in chronic pain states leading to continuous daily use.

Symptoms And Treatment Of Overdose: Symptoms and Treatment: See Fiorinal-C monograph.

Dosage And Administration: Adults: 2 tablets or capsules at once, followed if necessary, by 1 tablet or capsule every 3 to 4 hours; up to 6 capsules or tablets daily, or as prescribed.

Children: 1 to 3 tablets or capsules a day, according to age.

Availability And Storage: Capsules: Each hard gelatin, oblong capsule, purple opaque with blue opaque cap, printed with FIORINAL and

in white ink contains: butalbital, USP 50 mg, caffeine, USP 40 mg and ASA, USP 330 mg. Nonmedicinal ingredients: cornstarch, microcrystalline cellulose, stearic acid and talc. Bottles of 100 and 500.

Tablets: Each white compressed tablet embossed FIORINAL on one side and

on the other contains: butalbital, USP 50 mg, caffeine, USP 40 mg, ASA, USP 330 mg. Nonmedicinal ingredients: cornstarch, microcrystalline cellulose, silicon dioxide, sodium lauryl sulfate and stearic acid. Bottles of 100 and 500.

FIORINAL® Novartis Pharmaceuticals ASA – Caffeine – Butalbital Analgesic – Sedative

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