oxaydo oxycodone hydrochloride 5 mg

1 INDICATIONS AND USAGE OXAYDO is indicated for the management of acute and chronic 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 OXAYDO 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. OXAYDO is an opioid agonist indicated for the management of acute and chronic 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 OXAYDO 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.

zyla life sciences us inc.

FDA Reported Adverse Reactions
`[1] pain` `[2] drug dependence` `[3] overdose` `[4] toxicity to various agents` `[5] drug ineffective` `[6] death` `[7] emotional distress` `[8] nausea` `[9] fatigue` `[10] headache`

2 months ago

ROUND WHITE 0 5

16 HOW SUPPLIED/STORAGE AND HANDLING OXAYDO (oxycodone HCl) 5 mg tablets are round, convex, white tablets debossed with the strength “5” on one side and the letter “O” on the other side and supplied as: NDC 69344-113-11 Bottles of 100 tablets OXAYDO 7.5 mg tablets are round, convex, white tablets debossed with the strength “7.5” on one side and the letter “O” on the other side and supplied as: NDC 69344-213-11 Bottles of 100 tablets Dispense in tight container as defined in the USP, with a child-resistant closure. Store at 25°C (77°F); with excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature]. Protect from moisture. Store OXAYDO securely and dispose of properly [ see Patient Counseling Information ( 17 ) ].

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