oxycodone hydrochloride capsule
1. INDICATIONS AND USAGE Oxycodone hydrochloride capsule is an opioid agonist indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Oxycodone hydrochloride capsule is 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 capsules 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 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 capsules 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
glenmark pharmaceuticals, inc
CAPSULE YELLOW LV 901
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16. HOW SUPPLIED/STORAGE AND HANDLING Oxycodone hydrochloride capsule 5 mg is a hard gelatin capsule with an opaque yellow cap imprinted in black ink with "LV" and an opaque white body imprinted in black ink with "901" supplied as: NDC# 68462-204-01: Bottle of 100 capsules Dispense in a tight, light-resistant container. Protect from moisture and light. Store at 25°C (77°F); excursions are permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
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