oxycodone hydrochloride tablet
1 INDICATIONS AND USAGE Oxycodone hydrochloride tablets are 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 and Precautions (5.1) ] , reserve oxycodone 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. Oxycodone hydrochloride tablets are an opioid agonist indicated for the management of 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 oxycodone hydrochloride tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or non-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.
par pharmaceutical
ROUND GREEN V 48 11
V 48 11 ROUND GREEN
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16 HOW SUPPLIED/STORAGE AND HANDLING Oxycodone Hydrochloride Tablets, USP 5 mg: white, round, convex, scored tablets, debossed “4810” on one side and debossed “V” on the reverse side, are supplied as follows: Bottles of 100: NDC 0603-4990-21 Bottles of 500: NDC 0603-4990-28 10 mg: pink, round, convex, scored tablets, debossed “4993” on one side and debossed “V” on the reverse side, are supplied as follows: Bottles of 100: NDC 0603-4993-21 15 mg: light green, round, convex, scored tablets, debossed “4811” on one side and debossed “V” on the reverse side, are supplied as follows: Bottles of 100: NDC 0603-4991-21 Bottles of 500: NDC 0603-4991-28 20 mg: gray, round, convex, scored tablets, debossed “4994” on one side and debossed “V” on the reverse side, are supplied as follows: Bottles of 100: NDC 0603-4994-21 30 mg: light blue, round, convex, scored tablets, debossed “4812” on one side and debossed “V” on the reverse side, are supplied as follows: Bottles of 100: NDC 0603-4992-21 Bottles of 500: NDC 0603-4992-28 DEA Order Form Required Dispense in a tight, light-resistant container. Protect from moisture. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
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