Oxycodone Hydrochloride 15 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 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 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.

camber pharmaceuticals inc

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

4 years ago

ROUND YELLOW T 188

16 HOW SUPPLIED/STORAGE AND HANDLING

OXYCODONE HYDROCHLORIDE tablets USP are available as follows: 15 mg light yellow, round, biconvex, beveled edge tablets de-bossed with ‘T’ and break line on one side and ‘188’ on the other side. NDC 31722-917-01: Bottles of 100 tablets NDC 31722-917-05: Bottles of 500 tablets 30 mg light yellow, round, flat faced beveled edge tablets, de-bossed with ‘T’ and ‘189’ with a break line on one side and plain on the other side. NDC 31722-918-01: Bottles of 100 tablets NDC 31722-918-05: Bottles of 500 tablets 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 securely and dispose of properly [see Patient Counseling Information (17)] .

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camber pharmaceuticals inc

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