Oxycodone Hydrochloride 5 MG Oral Capsule
1 INDICATIONS AND USAGE 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. 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 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 ) L imitations 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
lannett company, inc.
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16 HOW SUPPLIED/STORAGE AND HANDLING
OXYCODONE HYDROCHLORIDE capsule 5 mg is a hard gelatin size #4 ivory opaque/reddish orange opaque capsule, imprinted with logo “LANNETT” on the cap and “1774” on the body available in one strength as follows: NDC# 0527-1774-01: Bottle of 100 capsules Store at 20°C to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container. Protect from moisture and light. Store
OXYCODONE HYDROCHLORIDE capsules securely and dispose of properly [see Patient Counseling Information 17 )].
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