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These highlights do not include all the information needed to use Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules safely and effectively. See full prescribing information for Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules. Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules for oral use, CIII Initial U.S. Approval: 1992
Medication labelWhy this: Advisory · dailymed-prescription
Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules are 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 Butalbital, Acetaminophen, 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.
- generic_name
- butalbital, acetaminophen, caffeine, and codeine phosphate
- product_names
- Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate
- ndc
- 79739-6670, 79739-6670-1, 79739-6670-5
- group
- drugs
- license
- us-gov-pd
- attribution
- Courtesy of the National Library of Medicine
- reviewed
- 2026-09-18
- language
- en