Oxycodone Hydrochloride 10 MG Oral Tablet

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.

American Health Packaging

FDA Reported Adverse Reactions
`[1] fatigue` `[2] dyspnoea` `[3] nausea` `[4] drug ineffective` `[5] diarrhoea` `[6] off label use` `[7] pain` `[8] vomiting` `[9] arthralgia` `[10] headache`

5 years ago

ROUND PINK K 56

16 HOW SUPPLIED/STORAGE AND HANDLING

OXYCODONE HYDROCHLORIDE tablets, USP are available as follows:

OXYCODONE HYDROCHLORIDE tablets, USP 5 mg are supplied as white round biconvex tablets debossed "K" on left and "18" on right of the bisect on one side and plain on the other side. Unit dose packages of 100 (10 x 10) NDC 68084-354-01

OXYCODONE HYDROCHLORIDE tablets, USP 10 mg are supplied as pink round biconvex tablets debossed "K" on left and "56" on right of the bisect on one side and plain on the other side. Unit dose packages of 100 (10 x 10) NDC 68084-968-01

OXYCODONE HYDROCHLORIDE tablets, USP 15 mg are supplied as green round biconvex tablets debossed "K" on left and "8" on right of the bisect on one side and plain on the other side. Unit dose packages of 100 (10 x 10) NDC 68084-975-01

OXYCODONE HYDROCHLORIDE tablets, USP 30 mg are supplied as blue round biconvex tablets debossed "K" on left and "9" on right of the bisect on one side and plain on the other side. Unit dose packages of 100 (10 x 10) NDC 68084-983-01 Protect from moisture. Store at 20° to 25°C (68° to 77°F) with excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. FOR YOUR PROTECTION: Do not use if blister is torn or broken.

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