FDA label
What is oxycodone and acetaminophen used for?
The FDA-approved uses of oxycodone and acetaminophen, quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label says: “Oxycodone and acetaminophen tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.”
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Oxycodone Hydrochloride and Acetaminophen, tablet
Indications and Usage, quoted from the label by SpecGx LLC (ANDA087463). Cross-references to other label sections are left out.
Oxycodone 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 (see WARNINGS ), reserve opioid analgesics, including oxycodone 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.
Source: DailyMed label, set id f2137f1a-b49a-40bd-97ac-cd6b36e295f4, version 48, effective July 27, 2026. NDC 0406-0512, one of 125 listings for this product.
Oxycodone and Acetaminophen, tablet
Indications and Usage, quoted from the label by KVK-Tech, Inc. (ANDA210644). Cross-references to other label sections are left out.
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 [see Warnings], reserve opioid analgesics, including oxycodone hydrochloride, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.
Source: DailyMed label, set id f9cf218c-af5e-4249-aa3b-a8555ed02278, version 21, effective May 4, 2026. NDC 10702-184, one of 4 listings for this product.
Oxycodone and Acetaminophen, tablet
Indications and Usage, quoted from the label by Granules Pharmaceuticals Inc. (ANDA211708). Cross-references to other label sections are left out.
Oxycodone 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
Source: DailyMed label, set id cc966d57-7cdc-4de3-bbcf-718e2fce9cb7, version 19, effective October 8, 2026. NDC 70010-667, one of 4 listings for this product.
Questions
What is oxycodone and acetaminophen used for?
The FDA label says: “Oxycodone and acetaminophen tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.”
What drug class is oxycodone and acetaminophen?
FDA lists oxycodone and acetaminophen in the Opioid Agonist established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.
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- NDC 0406-0512Oxycodone and Acetaminophen NDC record
- NDC 0406-0522Oxycodone and Acetaminophen NDC record
- NDC 0406-0523Oxycodone and Acetaminophen NDC record
- Schedule II drugs listDEA schedule