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Indications And Usage 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: 1) Butalbital, Aspirin, Caffeine And Codeine; 2) Codeine; 3) Butalbital, Aspirin And Caffeine; 4) 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 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 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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