oxycodone hydrochloride 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.
Caraco Pharmaceutical Laboratories, Ltd.
ROUND PINK 370
370 ROUND PINK
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16 HOW SUPPLIED/STORAGE AND HANDLING
OXYCODONE HYDROCHLORIDE tablets, USP are available as follows: 5 mg: white colored, round-shaped, biconvex, beveled edge, uncoated tablets, debossed with ‘223’ on one side and scored on the other side. NDC 57664-223-88 Bottles of 100 CRC 10 mg: pink colored, round-shaped, biconvex, beveled edge, uncoated tablets, debossed with ‘370’ on one side and scored on the other side. NDC 57664-370-88 Bottles of 100 CRC 15 mg: green colored, round-shaped, biconvex, beveled edge, uncoated tablets, debossed with ‘187’ on one side and scored on the other side. NDC 57664-187-88 Bottles of 100 CRC 20 mg: gray colored, round-shaped, biconvex, beveled edge, uncoated tablets, debossed with ‘371’ on one side and scored on the other side. NDC 57664-371-88 Bottles of 100 CRC 30 mg: blue colored, round-shaped, biconvex, beveled edge, uncoated tablets, debossed with ‘224’ on one side and scored on the other side. NDC 57664-224-88 Bottles of 100 CRC Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure. Store at 20° to 25°C (68° to 77°F). (See USP for Controlled Room Temperature). Protect from moisture.
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