oxymorphone hydrochloride tablet
1 INDICATIONS AND USAGE Oxymorphone hydrochloride tablets are 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 , 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 are indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. 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.
kvk-tech, inc.
ROUND RED K 71
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oxymorphone hydrochloride tablet
kvk-tech, inc.
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16 HOW SUPPLIED/STORAGE AND HANDLING
OXYMORPHONE HYDROCHLORIDE tablets are supplied as follows: 5 mg Tablet: blue, round, biconvex tablets debossed with “K” above “70” on one side and plain on the other. Bottles of 60 tablets with child-resistant closure NDC 10702-070-06 Bottles of 100 tablets with child-resistant closure NDC 10702-070-01 10 mg Tablet: red, round, biconvex tablets debossed with “K” above “71” on one side and plain on the other. Bottles of 60 tablets with child-resistant closure NDC 10702-071-06 Bottles of 100 tablets with child-resistant closure NDC 10702-071-01 Store at 20° to 25°C (68° to 77°F), with excursions permitted between 15° to 30°C (59° to 86°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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