Acetaminophen 325 MG Oxycodone Hydrochloride 5 MG Oral Tablet

INDICATIONS AND USAGE Oxycodone Hydrochloride and Acetaminophen Tablets 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, AND MISUSE, with opioids, even at recommended doses [see WARNINGS ], reserve Oxycodone Hydrochloride and Acetaminophen Tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics] Have not been tolerated, or are not expected to be tolerated, Have not provided adequate analgesia, or are not expected to provide adequate analgesia

Par Pharmaceutical

FDA Reported Adverse Reactions
`[1] drug ineffective` `[2] pain` `[3] pyrexia` `[4] infusion related reaction` `[5] off label use` `[6] fatigue` `[7] rash` `[8] hypersensitivity` `[9] pruritus` `[10] hepatic enzyme increased`

5 years ago

ROUND WHITE 4839 V

5 years ago

4839 V ROUND WHITE

HOW SUPPLIED Oxycodone Hydrochloride and Acetaminophen Tablets, USP, 5 mg/325 mg, supplied as a white round tablet, with one face, scored debossed 4839 and V, and the other plain, are available as follows: Bottles of 100: NDC 0603-4998-21 Bottles of 500: NDC 0603-4998-28 Storage Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture. Dispense in a tight, light-resistant container as defined in the USP. DEA Order Form Required. Store Oxycodone Hydrochloride and Acetaminophen Tablets securely and dispose of properly [see PRECAUTIONS/Information for Patients ].

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