Application Nr Approved Date Route Status External Links
ANDA203335 2015-10-30 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Butalbital, Aspirin, Caffeine, And Codeine Phosphate Capsules Is Indicated For The Management Of The Symptom Complex Of Tension (or Muscle Contraction) Headache, When Non-Opioid Analgesic And Alternative Treatments Are Inadequate. Butalbital, Aspirin, Caffeine, And Codeine Phosphate Capsules Is A Combination Of Butalbital, A Barbiturate, Aspirin, A Nonsteroidal Anti-Inflammatory Drug, Caffeine, A Methylxanthine, And Codeine Phosphate, An Opioid Agonist, And Is Indicated For The Management Of The Symptom Complex Of Tension (or Muscle Contraction) Headache, When Other Non-Opioid Analgesics And Alternative Treatments Are Inadequate. Limitations Of Use Because Of The Risks Of Addiction, Abuse, And Misuse With Opioids, Even At Recommended Doses, Reserve Butalbital, Aspirin, Caffeine, And Codeine Phosphate Capsules For Use In Patients For Whom Alternative Treatment Options (e.g., Non-Opioid Analgesics) (5.1): Have Not Been Tolerated, Or Are Not Expected To Be Tolerated, Have Not Provided Adequate Analgesia, Or Are Not Expected To Provide Adequate Analgesia Limitations Of Use Because Of The Risks Of Addiction, Abuse, And Misuse With Opioids And Butalbital, Even At Recommended Doses [see Warnings And Precautions (5.1)], Reserve Butalbital, Aspirin, Caffeine, And Codeine Phosphate Capsules For Use In Patients For Whom Alternative Treatment Options (e.g., Non-Opioid, Non-Barbiturate Analgesics): Have Not Been Tolerated, Or Are Not Expected To Be Tolerated, Have Not Provided Adequate Analgesia, Or Are Not Expected To Provide Adequate Analgesia

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. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
3. Stearic Acid STEARIC ACID Molecular MISC-Miscellaneous GRAS-Generally recognized as safe.

Active Ingredients ( 4 Total)

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