Application Nr Approved Date Route Status External Links
ANDA040864 2008-12-01 Oral DISCN Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Butalbital, Acetaminophen And Caffeine Tablet 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. Magnesium Stearate MAGNESIUM STEARATE Molecular AF-Antifoaming (or defoaming) agent , MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
2. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
3. Povidones POVIDONES Unresolved

Active Ingredients ( 3 Total)

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