Oxycodone Hydrochloride 5 MG Oral Capsule
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. Oxycodone hydrochloride capsules 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 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
Mayne Pharma Inc.
CAPSULE WHITE 0145
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16 HOW SUPPLIED/STORAGE AND HANDLING
OXYCODONE HYDROCHLORIDE capsules 5 mg are hard gelatin white capsules imprinted with "0145" on the cap or body in black ink available in one strength as follows: NDC# 68308-145-01: Bottle of 100 capsules Dispense in a tight, light-resistant container. Protect from moisture and light. Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature.] Store
OXYCODONE HYDROCHLORIDE capsules securely and dispose of properly [see Patient Counseling Information 17 )].
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