Butalbital, acetaminophen and caffeine tablets 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.
CONTRAINDICATIONS
This product is contraindicated under the following conditions: Hypersensitivity or intolerance to any component of this product Patients with porphyria.
Warnings
BOXED WARNING
CONTRAINDICATIONS
This product is contraindicated under the following conditions: Hypersensitivity or intolerance to any component of this product Patients with porphyria.
WARNINGS
Directions And Dosage
OVERDOSAGE
Following an acute overdosage of butalbital, acetaminophen and caffeine, toxicity may result from the barbiturate or the acetaminophen. Toxicity due to caffeine is less likely, due to the relatively small amounts in this formulation.
DOSAGE AND ADMINISTRATION
One or two tablets every four 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.
Butalbital, Acetaminophen and Caffeine Tablets, USP are supplied in tablet form for oral administration. Each tablet contains the following active ingredients: butalbital, USP 50 mg acetaminophen, USP 325 mg caffeine, USP 40 mg Inactive Ingredients: silicon dioxide, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, and stearic acid. Butalbital (5-allyl-5-isobutylbarbituric acid), is a short to intermediate-acting barbiturate. It has the following structural formula: Acetaminophen (4'-hydroxyacetanilide), is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula: Caffeine (1,3,7-trimethylxanthine), is a central nervous system stimulant. It has the following structural formula:
CLINICAL PHARMACOLOGY
CLINICAL PHARMACOLOGY SECTION
This combination drug product is intended as a treatment for tension headache. It consists of a fixed combination of butalbital, acetaminophen and caffeine. The role each component plays in the relief of the complex of symptoms known as tension headache is incompletely understood.
INDICATIONS AND USAGE
INDICATIONS & USAGE SECTION
Butalbital, acetaminophen and caffeine tablets 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.
CONTRAINDICATIONS
CONTRAINDICATIONS SECTION
This product is contraindicated under the following conditions: Hypersensitivity or intolerance to any component of this product Patients with porphyria.
WARNINGS
WARNINGS SECTION
PRECAUTIONS
PRECAUTIONS SECTION
ADVERSE REACTIONS
ADVERSE REACTIONS SECTION
DRUG ABUSE AND DEPENDENCE
DRUG ABUSE AND DEPENDENCE SECTION
OVERDOSAGE
OVERDOSAGE SECTION
Following an acute overdosage of butalbital, acetaminophen and caffeine, toxicity may result from the barbiturate or the acetaminophen. Toxicity due to caffeine is less likely, due to the relatively small amounts in this formulation.
DOSAGE AND ADMINISTRATION
DOSAGE & ADMINISTRATION SECTION
One or two tablets every four 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.
