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These highlights do not include all the information needed to use FIORICET with CODEINE safely and effectively. See full prescribing information for FIORICET with CODEINE. FIORICET® with CODEINE (butalbital, acetaminophen, caffeine, and codeine phosphate) Capsules, for oral use, CIII Initial U.S. Approval: 1992
Medication labelWhy this: Advisory · dailymed-prescription
FIORICET with CODEINE is indicated for the management of the symptom complex of tension (or muscle contraction) headache when non-opioid analgesic 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 FIORICET 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.
- generic_name
- butalbital, acetaminophen, caffeine, and codeine phosphate
- product_names
- Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate
- ndc
- 52544-082, 52544-082-01
- group
- drugs
- license
- us-gov-pd
- attribution
- Courtesy of the National Library of Medicine
- reviewed
- 2026-09-18
- language
- en