Migraine and headache:

Indications for: Butalbital/Aspirin/Caffeine

Tension (or muscle contraction) headache.

Adult Dosage:

Use lowest effective dose for shortest duration. Not recommended for extended or repeated use. 1–2 caps every 4hrs, as needed; max 6 caps/day. 

Children Dosage:

Not established.

Butalbital/Aspirin/Caffeine Contraindications:

Hemorrhagic diathesis (eg, hemophilia, hypoprothrombinemia, von Willebrand's disease, the thrombocytopenias, thrombasthenia and other ill-defined hereditary platelet dysfunctions, severe vitamin K deficiency, severe liver damage). Syndrome of nasal polyps, angioedema and bronchospastic reactivity to aspirin or other nonsteroidal anti-inflammatory drugs. Peptic ulcer or other serious GI lesions. Porphyria.

Butalbital/Aspirin/Caffeine Warnings/Precautions:

Abuse potential. Bleeding disorders. Coagulation disorders. Head injuries. Elevated intracranial pressure. Acute abdominal conditions. Hypothyroidism. Urethral stricture. Addison's disease. Prostatic hypertrophy. Underlying hemostatic defects. Reye's syndrome. Children/teenagers with chicken pox or flu. Asthma. Aspirin allergy. Severe renal or hepatic impairment. Elderly. Debilitated. Embryo-fetal toxicity. Pregnancy (avoid during ≥30 weeks gestation): increased risk of premature closure of the fetal ductus arteriosus; (20–30 weeks gestation): may cause fetal renal dysfunction/oligohydramnios; if treatment needed, limit dose and duration of use. Risk of neonatal opioid withdrawal syndrome during prolonged use. Labor & delivery, nursing mothers: not recommended.

Butalbital/Aspirin/Caffeine Classification:

Barbiturate + salicylate + methylxanthine.

Butalbital/Aspirin/Caffeine Interactions:

Additive effects of CNS depression with alcohol and other CNS depressants (eg, narcotic analgesics, general anesthetics, tranquilizers, chlordiazepoxide, sedative-hypnotics); avoid. Concomitant MAOIs may enhance CNS effects. Increased risk of bleeding with concomitant NSAIDs (avoid), oral anticoagulants. Increased hypoglycemia with oral antidiabetic agents, insulin. Withdrawal of corticosteroids may result in salicylism in those receiving concomitant corticosteroids and chronic use of aspirin. May potentiate 6-mercaptopurine, methotrexate. Antagonizes uricosuric agents (eg, probenecid, sulfinpyrazone). May interfere with lab tests in blood or urine (eg, serum amylase, fasting blood glucose, cholesterol, protein, SGOT, uric acid, prothrombin time, bleeding time, glucose, 5- hydroxyindoleacetic acid, Gerhardt ketone, VMA, uric acid, diacetic acid, and spectrophotometric detection of barbiturates).

Adverse Reactions:

Drowsiness, dizziness, lightheadedness, nausea, vomiting, flatulence; hypersensitivity reactions, DRESS (discontinue if occurs), erythema multiforme, TEN.


Formerly known under the brand name Fiorinal.

How Supplied:

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