Oxycodone Hydrochloride 5 MG Oral Tablet

1 INDICATIONS AND USAGE Oxycodone Hydrochloride Tablets is 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 , 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 Tabletsis 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 usein 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 expectedto provide adequate analgesia.

Aurolife Pharma LLC

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

5 years ago

ROUND WHITE U22

5 years ago

U22 ROUND WHITE

16 HOW SUPPLIED/STORAGE AND HANDLING

OXYCODONE HYDROCHLORIDE tablets, USP are available as follows: 5 mg white to off white, round tablets, debossed with “U22” on one side and breakline on the other side. Bottles of 30 NDC 13107-055-30 Bottles of 100 NDC 13107-055-01 Bottles of 1000 NDC 13107-055-99 15 mg Light green to green, round tablets, debossed with “U23” on one side and breakline on the other side. Bottles of 30 NDC 13107-056-30 Bottles of 100 NDC 13107-056-01 Bottles of 1000 NDC 13107-056-99 30 mg Light blue to blue, round tablets, debossed with “U24” on one side and breakline on the other side. Bottles of 30 NDC13107-057-30 Bottles of 100 NDC13107-057-01 Bottles of 1000 NDC 13107-057-99 DEA Order Form Required Dispense in a tight, light-resistant container. 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 )].

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