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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, CIIIInitial 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, misuse, overdose, and death, which can occur at any dosage or duration, and persist over the course of therapy, [see Warnings and Precautions ( 5.1 )] , reserve opioid analgesics, including Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.
- generic_name
- butalbital, acetaminophen, caffeine and codeine phosphate
- product_names
- Butalbital, Acetaminophen, Caffeine and Codeine Phosphate
- ndc
- 0054-0650, 0054-3000, 0054-0650-25, 0054-3000-01
- group
- drugs
- license
- us-gov-pd
- attribution
- Courtesy of the National Library of Medicine
- reviewed
- 2026-09-18
- language
- en