Application Nr Approved Date Route Status External Links
ANDA213321 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications & Usage Butalbital, Acetaminophen And Caffeine Capsules Are 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 (0 Total)

None

Active Ingredients ( 3 Total)

Name Structure ZINC ID(s)
1. Acetaminophen ACETAMINOPHEN ZINC13550868
2. Butalbital BUTALBITAL ZINC3830347
3. Caffeine CAFFEINE ZINC1084

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