What Is Prolate Used For? FDA-Approved Uses

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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Prolate, tablet

Indications and Usage, quoted from the label by Forte Bio-Pharma LLC (ANDA040608). 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 course of therapy, 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 9cbbfa94-37b9-9652-e053-2995a90a736b, version 9, effective May 19, 2026. NDC 72245-681, one of 3 listings for this product.

Prolate, solution

Indications and Usage, quoted from the label by Forte Bio-Pharma LLC (ANDA202142). Cross-references to other label sections are left out.

Oxycodone hydrochloride and acetaminophen oral solution is 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 oxycodone hydrochloride and acetaminophen oral solution, 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 9d75ad3b-bc9b-0c22-e053-2a95a90ac71e, version 8, effective July 28, 2026. NDC 72245-648, one of 1 listing for this product.

Questions

What is Prolate 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 Prolate?

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.