oxycodone hydrochloride 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. 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 tablet is 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.

epic pharma, llc

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

5 years ago

ROUND GREEN E 7

16 HOW SUPPLIED/STORAGE AND HANDLING

OXYCODONE HYDROCHLORIDE Tablets USP, 5 mg are white, round biconvex tablets debossed the “ϵ” to the left of bisect and “5” to the right of bisect on one side and plain on the other side. NDC 42806-005-01 Bottles of 100

OXYCODONE HYDROCHLORIDE Tablets USP, 10 mg are yellow, round biconvex tablets debossed “ϵ” to the left of bisect and “6” to the right of bisect on one side and plain on the other side. NDC 42806-006-01 Bottles of 100

OXYCODONE HYDROCHLORIDE Tablets USP, 15 mg are green, round biconvex tablets debossed “ϵ” to the left of bisect and “7” to the right of bisect on one side and plain on the other side. NDC 42806-007-01 Bottles of 100

OXYCODONE HYDROCHLORIDE Tablets USP, 20 mg are gray, round biconvex tablets, debossed ”ϵ” to the left of bisect and “9” to the right of bisect on one side and plain on the other side. NDC 42806-009-01 Bottles of 100

OXYCODONE HYDROCHLORIDE Tablets USP, 30 mg are blue, round biconvex tablets debossed “ϵ” to the left of bisect and “8” to the right of bisect on one side and plain on the other side. NDC 42806-008-01 Bottles of 100 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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