oxycodone hydrochloride 5 mg
1 INDICATIONS AND USAGE Oxycodone Hydrochloride Capsules are an opioid agonist indicated in adults 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, which can occur at any dosage or duration, [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 Oxycodone Hydrochloride Capsules 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. Oxycodone Hydrochloride Capsules are an opioid agonist indicated in adults 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, which can occur at any dosage or duration, 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 Oxycodone Hydrochloride Capsules 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.
ANI Pharmaceuticals, Inc.
CAPSULE YELLOW ANI 167
ANI 167 CAPSULE YELLOW
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16 HOW SUPPLIED/STORAGE AND HANDLING
OXYCODONE HYDROCHLORIDE capsules 5 mg are hard gelatin capsules with an opaque yellow cap and an opaque white body imprinted with ‘ANI’ on the cap and ‘167’ on the body in black ink available as follows: NDC 62559-167-01: Bottle of 100 capsules Dispense in a tight, light-resistant container. Protect from moisture and light. Store at 20° to 25°C (68° to 77°F); excursions permitted at 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Store
OXYCODONE HYDROCHLORIDE capsules securely and dispose of properly [see Patient Counseling Information ( 17 )] .
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