Application Nr Approved Date Route Status External Links
ANDA200243 2012-09-13 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Butalbital, Acetaminophen, And Caffeine Tablets, Usp 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 (6 Total)

Name Structure Kind Function Status
1. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
2. Croscarmellose Sodium CROSCARMELLOSE SODIUM Unresolved
3. Starch, Corn STARCH, CORN Unresolved
4. Stearic Acid STEARIC ACID Molecular MISC-Miscellaneous GRAS-Generally recognized as safe.
5. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
6. 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.

Active Ingredients ( 3 Total)