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oxymorphone hydrochloride tablet

1 INDICATIONS AND USAGE Oxymorphone hydrochloride is indicated for the management of acute 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 and Precautions ( 5.1 )] , reserve oxymorphone hydrochloride for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: • Have not been tolerated, or are not expected to be tolerated, • Have not provided adequate analgesia, or are not expected to provide adequate analgesia Oxymorphone hydrochloride is an opioid agonist indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. ( 1 ) Limitations of Use ( 1 ) Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve oxymorphone hydrochloride for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: • Have not been tolerated, or are not expected to be tolerated, • Have not provided adequate analgesia, or are not expected to provide adequate analgesia

west-ward pharmaceuticals corp.


2 years ago ROUND WHITE 54 956 oxymorphone hydrochloride tablet

ROUND WHITE 54 956

16 HOW SUPPLIED/STORAGE AND HANDLING

OXYMORPHONE HYDROCHLORIDE Tablets USP 5 mg tablet is supplied as a round, white to off-white, standard biconvex tablet debossed with product identification “54” over “956” on one side and plain on the other side. NDC 0054-0283-25: Bottle of 100 Tablets 10 mg tablet is supplied as a round, white to off-white, standard biconvex tablet debossed with product identification “54” over “814” on one side and plain on the other side. NDC 0054-0284-25: Bottle of 100 Tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant, child-resistant container as defined in the USP/NF. Store

OXYMORPHONE HYDROCHLORIDE Tablets USP securely and dispose of properly [see Patient Counseling Information ( 17 )].

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oxymorphone hydrochloride tablet

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