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Hydrocodone and acetaminophen is a prescription combination analgesic for pain severe enough to require an opioid when alternative treatments are inadequate. Current tablets include hydrocodone bitartrate strengths of 5 mg, 7.5 mg, or 10 mg combined with 325 mg of acetaminophen. The product is a Schedule II controlled substance.
read more about hydrocodone and acetaminophen ...Hydrocodone is a mu-opioid receptor agonist that changes pain perception in the central nervous system. Acetaminophen is a nonopioid analgesic and antipyretic with a pain-relieving mechanism that is not fully defined. Combining the two ingredients produces analgesia through different pharmacologic actions.
The combination is used for pain severe enough to require an opioid when nonopioid treatments or other alternatives are inadequate. Dose selection reflects prior opioid exposure, pain severity, response, and risk factors for opioid-related adverse reactions.
The 5 mg/325 mg strength starts at one to two tablets every four to six hours as needed, with no more than eight tablets daily. The 7.5 mg/325 mg and 10 mg/325 mg strengths start at one tablet every four to six hours as needed, with no more than six tablets daily. Total acetaminophen from all sources stays below 4,000 mg daily.
The boxed warning covers serious opioid risks and acetaminophen-associated liver toxicity. Hydrocodone can cause addiction, misuse, life-threatening respiratory depression, accidental ingestion, neonatal opioid withdrawal, and dangerous interactions with central nervous system depressants. Acetaminophen overdose can cause acute liver failure, liver transplant, or death.
Current labeled tablets contain 5 mg/325 mg, 7.5 mg/325 mg, or 10 mg/325 mg of hydrocodone bitartrate and acetaminophen.
The labeled maximum is eight tablets in 24 hours.
The labeled maximum is six tablets in 24 hours.
Excess acetaminophen can cause severe liver injury, including acute liver failure.
Acetaminophen; Hydrocodone Bitartrate. PubChem. https://pubchem.ncbi.nlm.nih.gov/compound/5748525. Date Accessed October 1, 2026.
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Definition of Hydrocodone/Acetaminophen. National Cancer Institute. https://www.cancer.gov/publications/dictionaries/cancer-drug/def/hydrocodone-acetaminophen. Date Accessed October 1, 2026.
Hydrocodone and Acetaminophen. StatPearls. https://www.ncbi.nlm.nih.gov/books/NBK538530/. Date Accessed October 1, 2026.
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