Product manufactured by Cardinal Health

Application Nr Approved Date Route Status External Links
ANDA088616 1984-11-09 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Fioricet (butalbital, Acetaminophen, And Caffeine Tablets, Usp) Is Indicated For The Relief Of The Symptom Complex Of Tension (or Muscle Contraction) Headache. Evidence Supporting The Efficacy And Safety Of Fioricet 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)