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acetaminophen/butalbital/caffeine/codeine
acetaminophen/butalbital/caffeine/codeine
Last updated: Apr. 7, 2026
- RCRA: Disposal
- RCRA: Management of Pharmaceutical Waste Policy
- Black Box Warning: Acetaminophen: Hepatotoxicity
- Black Box Warning: Codeine in children: death due to ultra-rapid metabolism
- Black Box Warning: Addiction, abuse, and misuse; risk evaluation and mitigation strategy (rems); life-threatening respiratory depression; accidental ingestion; risks from concomitant use with benzodiazepines or other cns depressants; ultra-rapid metabolism of codeine...
- REMS: Opioid Analgesic REMS-FDA REMS Info
- REMS: Legacy Health REMS Requirements-Opioid Analgesics
Class III
Non-formulary agent
For additional information regarding pediatric use, see FDA Drug Safety Communication
The Opioid Analgesic REMS program includes health care provider and patient related requirements for prescribing, see Legacy Health REMS Requirements for detail.