oxymorphone hydrochloride tablet
1 INDICATIONS & USAGE Oxymorphone Hydrochloride Tablets 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, which can occur at any dosage or duration [see Warnings and Precautions (5.1)], reserve Oxymorphone Hydrochloride Tablets 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 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. Oxymorphone Hydrochloride Tablets 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, which can occur at any dosage or duration, reserve Oxymorphone Hydrochloride Tablets 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, (1) • Have not provided adequate analgesia or are not expected to provide adequate analgesia (1) Oxymorphone Hydrochloride 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.
aurolife pharma, llc
ROUND PINK U86
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16 HOW SUPPLIED/STORAGE AND HANDLING
OXYMORPHONE HYDROCHLORIDE Tablets are supplied as follows:
OXYMORPHONE HYDROCHLORIDE Tablets, 5 mg are light blue to blue colored, mottled, round, uncoated tablets, debossed with 'U85' on one side and plain on the other side. Bottles of 30 NDC 13107-103-30 Bottles of 100 NDC 13107-103-01 Bottles of 1000 NDC 13107-103-99
OXYMORPHONE HYDROCHLORIDE Tablets, 10 mg are light peach to peach colored, mottled, round, uncoated tablets, debossed with 'U86' on one side and plain on the other side. Bottles of 30 NDC 13107-104-30 Bottles of 100 NDC 13107-104-01 Bottles of 1000 NDC 13107-104-99 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in tight container as defined in the USP, with a child-resistant closure (as required). Store
OXYMORPHONE HYDROCHLORIDE Tablets securely and dispose of properly [see Patient Counseling Information (17)].
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