Acetaminophendrug info
acetaminophen 300 MG / hydrocodone bitartrate 10 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, 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 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 March 23, 2026. 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 is 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 4,5-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 non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula: Each Hydrocodone Bitartrate and Acetaminophen Tablet, 5 mg/300 mg contains: Hydrocodone Bitartrate.................................................................................................................5 mg Acetaminophen...........................................................................................................................300 mg Each Hydrocodone Bitartrate and Acetaminophen Tablet, 7.5 mg/300 mg contains: Hydrocodone Bitartrate............................................................................................................7.5 mg Acetaminophen........................................................................................................................300 mg Each Hydrocodone Bitartrate and Acetaminophen Tablets, 10 mg/300 mg contains: Hydrocodone Bitartrate.............................................................................................................10 mg Acetaminophen.........................................................................................................................300 mg In addition, each tablet contains the following inactive ingredients: pregelatinized starch, colloidal silicon dioxide, povidone, crospovidone, croscarmellose sodium, stearic acid, microcrystalline cellulose, magnesium stearate, and FD&C Yellow # 6 Aluminum Lake (5 mg/300 mg only), and FD&C Blue # 1 Aluminum Lake (10 mg/300 mg only). This product complies with USP dissolution test 2.
Text above is quoted in full from the FDA-approved drug label published by openFDA, effective March 23, 2026. 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.
See what it costs — price without insurance