Product manufactured by Mayne Pharma Inc.

Application Nr Approved Date Route Status External Links
ANDA089007 1986-03-17 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage ZebutalĀ® (butalbital, Acetaminophen And Caffeine Capsules) Usp 50 Mg/325 Mg/40 Mg Is 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.

All Formulated Excipients (3 Total)

Name Structure Kind Function Status
1. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
2. Croscarmellose Sodium CROSCARMELLOSE SODIUM Unresolved
3. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye

Active Ingredients ( 3 Total)