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, even at recommended doses [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 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 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.
specgx llc
FDA Reported Adverse Reactions
[1] pain [2] fatigue [3] death [4] drug ineffective [5] nausea [6] diarrhoea [7] dyspnoea [8] headache [9] off label use [10] dizziness
4 years ago
ROUND WHITE M 05 52
4 years ago
M 05 52 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 â0552â 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 â10â 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 â15â 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 â20â 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 â30â 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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