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**Acetaminophen + butalbital + caffeine + codeine** is an FDA-approved oral fixed-dose combination product used for the management of the symptom complex of tension or muscle contraction headache when non-opioid and other alternative treatments are inadequate. It combines **acetaminophen**, a non-opioid analgesic and antipyretic; **butalbital**, a barbiturate central nervous system depressant/sedative; **caffeine**, a methylxanthine central nervous system stimulant that can augment analgesic efficacy; and **codeine**, an opioid agonist analgesic. The exact mechanism by which the combination relieves tension headache is not fully established, but clinical effect is thought to arise from complementary analgesic, sedative, and adjuvant stimulant actions in the central nervous system. Because it contains both an opioid and a barbiturate, it carries important risks including addiction, abuse, misuse, overdose, medication-overuse headache, and acetaminophen-related hepatotoxicity.
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