Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, USP
Revised: January 2007
Each capsule, for oral administration, contains:Codeine Phosphate, USP.
Butalbital, aspirin, caffeine, and codeine phosphate capsules are indicated for the relief of the symptom complex of tension (or muscle contraction) headache.
Evidence supporting the efficacy of butalbital, aspirin, caffeine, and codeine phosphate capsules is derived from 2 multi-clinic trials that compared patients with tension headache randomly assigned to 4 parallel treatments: butalbital, aspirin, caffeine, and codeine phosphate; codeine; butalbital, aspirin, and caffeine; and placebo. Response was assessed over the course of the first 4 hours of each of 2 distinct headaches, separated by at least 24 hours. The combination product of butalbital, aspirin, caffeine, and codeine phosphate, proved statistically significantly superior to each of its components and to placebo on measures of pain relief.
Evidence supporting the efficacy and safety of butalbital, aspirin, caffeine, and codeine phosphate capsules 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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Published Studies Related to Butalbital, Aspirin, Caffeine, and Codeine (Codeine / Butalbital / Caffeine / Aspirin)
Comparison of butorphanol nasal spray and fiorinal with codeine in the treatment of migraine. [1998.07]
Butorphanol tartrate is a synthetic mixed agonist-antagonist opioid analgesic. Its transnasal dosage form, which may be self-administered when the use of an opioid analgesic is appropriate, was previously shown to provide rapid relief of migraine pain... Butorphanol patients had more side effects, less improvement in digestive symptoms, and less improvement in functional ability than Fiorinal with Codeine patients.
Fiorinal with codeine in the treatment of tension headache--the contribution of components to the combination drug. 
The contribution of the Fiorinal and codeine phosphate components to the effectiveness of the Fiorinal with Codeine combination in the treatment of tension headache symptoms was evaluated in a randomized, placebo-controlled, multicenter double-blind study...
Page last updated: 2015-05-14