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oxycodone 5 mg

1 INDICATIONS AND USAGE Oxycodone hydrochloride tablets are 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, which can occur at any dosage or duration [see Warnings and Precautions ( 5.1 )] , reserve oxycodone hydrochloride tablets 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. 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.

Mallinckrodt, Inc.


5 years ago ROUND WHITE 05 52 M oxycodone 5 mg

ROUND WHITE 05 52 M

5 years ago ROUND WHITE 05 52 M oxycodone 5 mg

05 52 M ROUND WHITE

16 HOW SUPPLIED/STORAGE AND HANDLING

OXYCODONE HYDROCHLORIDE Tablet USP are available as follows: Each

OXYCODONE HYDROCHLORIDE Tablet USP 5 mg is available as a white round convex tablet with a on one side and “0552” with a vertical bisect between the fives on the other. Bottles of 100............................. NDC 0406-0552-01 Unit Dose (10 x 10)................... NDC 0406-0552-62 Each

OXYCODONE HYDROCHLORIDE Tablet USP 10 mg is available as a mottled pink round convex tablet with a on one side and “10” above a bisect on the other. Bottles of 100............................. NDC 0406-8510-01 Unit Dose (10 x 10)................... NDC 0406-8510-62 Each

OXYCODONE HYDROCHLORIDE Tablet USP 15 mg is available as a light green round convex tablet with a on one side and “15” above a bisect on the other. Bottles of 100............................. NDC 0406-8515-01 Unit Dose (10 x 10)................... NDC 0406-8515-62 Each

OXYCODONE HYDROCHLORIDE Tablet USP 20 mg is available as a mottled gray round convex tablet with a on one side and “20” above a bisect on the other. Bottles of 100............................. NDC 0406-8520-01 Unit Dose (10 x 10)................... NDC 0406-8520-62 Each

OXYCODONE HYDROCHLORIDE Tablet USP 30 mg is available as a light blue round convex tablet with a on one side and “30” above a bisect on the other. Bottles of 100............................. NDC 0406-8530-01 Unit Dose (10 x 10)................... NDC 0406-8530-62 Dispense in a tight, light-resistant container with child-resistant closure. Protect from moisture. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Store

OXYCODONE HYDROCHLORIDE tablets securely and dispose of properly [see Patient Counseling Information (17) ] . Boxed M Boxed M Boxed M Boxed M Boxed M


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