oxycodone 10 mg acetaminophen 325 mg
INDICATIONS AND USAGE Oxycodone 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, which can occur at any dosage or duration [see WARNINGS ] , reserve oxycodone 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 Oxycodone and Acetaminophen Tablets should not be used for an extended period of time unless the pain remains severe enough to require an opioid analgesic and for which alternative treatment options continue to be inadequate.
lupin pharmaceuticals,inc.
ROUND WHITE n 493
n 493 ROUND WHITE
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HOW SUPPLIED
OXYCODONE AND ACETAMINOPHEN Tablets, USP is supplied as follows: 2.5 mg/325 mg white, round, flat face tablet debossed with "n" and "490" on one side and plain on the other side. Bottles of 100 NDC 43386-490-01 Bottles of 500 NDC 43386-490-05 Bottles of 1000 NDC 43386-490-10 5 mg/325 mg white, round, flat face tablet debossed with "n" and "491" on one side and bisect on the other side. Bottles of 100 NDC 43386-491-01 Bottles of 500 NDC 43386-491-05 Bottles of 1000 NDC 43386-491-10 7.5 mg/325 mg white, round, flat face tablet debossed with "n" and "492" on one side and plain on the other side. Bottles of 100 NDC 43386-492-01 Bottles of 500 NDC 43386-492-05 Bottles of 1000 NDC 43386-492-10 10 mg/325 mg white, round, flat face tablet debossed with "n" and "493" on one side and plain on the other side. Bottles of 100 NDC 43386-493-01 Bottles of 500 NDC 43386-493-05 Bottles of 1000 NDC 43386-493-10 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. Store
OXYCODONE AND ACETAMINOPHEN Tablets securely and dispose of properly [see PRECAUTIONS/Information for Patients ]. Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 SAP Code: 275918 Rev. 02/2024
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