Acetaminophendrug info
acetaminophen 300 MG / hydrocodone bitartrate 7.5 MG Oral Tablet
What it is used for
Hydrocodone bitartrate and acetaminophen tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse, overdose and death, which can occur at any dosage or duration and persist over the course of therapy, reserve opioid analgesics, including hydrocodone bitartrate and acetaminophen tablets for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain..
Text above is quoted in full from the FDA-approved drug label published by openFDA, effective December 17, 2025. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.
Description
Hydrocodone bitartrate and acetaminophen are available in tablet form for oral administration. Hydrocodone bitartrate is an opioid analgesic and occurs as fine, white crystals or as a crystalline powder. It is affected by light. The chemical name is 4,5α-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It has the following structural formula: Acetaminophen, 4' -hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a nonopiate, non-salicylate analgesic and antipyretic. It has the following structural formula: Hydrocodone Bitartate and Acetaminophen Tablets USP is available in the following strengths: Acetaminophen USP…………………. 300 mg Hydrocodone Bitartrate USP………… 5 mg WARNING: May be habit-forming. Acetaminophen USP…………………. 300 mg Hydrocodone Bitartrate USP………… 7.5 mg WARNING: May be habit-forming. Acetaminophen USP…………………. 300 mg Hydrocodone Bitartrate USP………… 10 mg WARNING: May be habit-forming. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch (maize) and stearic acid. This product complies with USP Dissolution Test 1. Chemical Structure Chemical Structure
Text above is quoted in full from the FDA-approved drug label published by openFDA, effective December 17, 2025. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.
This page reproduces regulatory text for reference. It is not medical advice, and KenyRx is not a pharmacy or a prescriber. Talk to a doctor or pharmacist about whether a medicine is right for you.
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