Oxycodone Hydrochloride 15 MG Oral Tablet
1 INDICATIONS AND USAGE Oxycodone Hydrochloride Tablets, USP are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. 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: Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration, 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. Oxycodone hydrochloride tablets 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. 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 Tablets, USP 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 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.
Rhodes Pharmaceuticals L.P.
OVAL WHITE R P 15
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16 HOW SUPPLIED/STORAGE AND HANDLING
OXYCODONE HYDROCHLORIDE Tablets, USP are available as follows: 5 mg – white to off-white, round, flat faced, beveled edged tablets debossed with "R" above bisect and "P" below on one side and "5" on the other side NDC 42858-001-01: Bottles of 100 tablets NDC 42858-001-10: Unit Dose Packages of 100, 10 per Card, 10 cards per shipper 10 mg – white to off-white, round, biconvex tablets debossed with "R" above bisect and "P" below on one side and "10" on the other side NDC 42858-002-01 Bottles of 100 tablets NDC 42858-002-10: Unit Dose Packages of 100, 10 per Card, 10 cards per shipper 15 mg – white to off-white, oval tablets with "R" and "P" (with a center score) on one side and "15" on the other side NDC 42858-003-01: Bottles of 100 tablets 20 mg – white to off-white, round, biconvex tablets debossed with "R" above bisect and "P" below on one side and "20" on the other side NDC 42858-004-01: Bottles of 100 tablets 30 mg – white to off-white, round, biconvex tablets debossed with "R" above bisect and "P" below on one side and "30" on the other side NDC 42858-005-01: Bottles of 100 tablets Dispense in a tight, light-resistant container. Protect from moisture. Store at 25°C (77°F); excursions are permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Store
OXYCODONE HYDROCHLORIDE tablets securely and dispose of properly [see Patient Counseling Information (17) ] .
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