Application Nr Approved Date Route Status External Links
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Indications and Purposes

1 Indications And Usage Ascomp With Codeine 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 And Butalbital, Even At Recommended Doses [See Warnings And Precautions (5.1)] , Reserve Ascomp With Codeine 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 (0 Total)

None

Active Ingredients ( 4 Total)

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