Butalbital, Acetaminophen, Caffeine, and Codeine (Codeine Phosphate / Butalbital / Caffeine / Acetaminophen) - Summary

SUMMARY

BUTALBITAL, ACETAMINOPHEN, CAFFEINE,
AND CODEINE PHOSPHATE CAPSULES

Butalbital, acetaminophen, caffeine, and codeine phosphate is supplied in capsule form for oral administration. Each capsule contains: codeine phosphate USP, 30 mg; butalbital USP, 50 mg; caffeine USP, 40 mg; acetaminophen USP, 325 mg.

Codeine phosphate [morphine-3-methyl ether phosphate (1:1) (salt) hemihydrate, C₁₈H₂₄NO₇P, anhydrous M.W. 397.37], is a narcotic analgesic and antitussive.

Butalbital (5-allyl-5-isobutylbarbituric acid, C₁₁H₁₆N₂O₃, M.W. 224.26), is a short- to intermediate-acting barbiturate.

Caffeine (1,3,7-trimethylxanthine, C₈H₁₀N₄O₂, M.W. 194.19), is a central nervous system stimulant.

Acetaminophen (4´-hydroxyacetanilide, C₈H₉NO₂, M.W. 151.16), is a non-opiate, non-salicylate analgesic and antipyretic.

Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules are indicated for the relief of the symptom complex of tension (or muscle contraction) headache.

Evidence supporting the efficacy and safety of butalbital, acetaminophen, caffeine, and 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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