Oxycodone Hydrochloride 5 MG Oral Tablet
1 INDICATIONS AND USAGE Oxycodone hydrochloride (HCl) 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 HCl 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 HCl tablets are an opioid agonist indicated for the management of pain sever 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 HCl 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.
zydus pharmaceuticals (usa) inc.
ROUND ORANGE N P 11
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16 HOW SUPPLIED/STORAGE AND HANDLING Oxycodone HCl tablets, USP are available as follows: 5 mg: orange round, flat face, bevel edge tablets, debossed "NP" (closed P) with a partial bisect on one side and "11" on the other. NDC 68382-793-01 – Bottle of 100 Tablets 10 mg: pink round, flat face, bevel edge tablets, debossed "NP" (closed P) with a partial bisect on one side and "12" on the other. NDC 68382-794-01 – Bottle of 100 Tablets 15 mg: yellow round, flat face, bevel edge tablets, debossed "NP" (closed P) with a partial bisect on one side and "13" on the other. NDC 68382-795-01 – Bottle of 100 Tablets 20 mg: gray round, flat face, bevel edge tablets, debossed "NP" (closed P) with a partial bisect on one side and "14" on the other. NDC 68382-796-01 – Bottle of 100 Tablets 30 mg: white round, flat face, bevel edge tablets, debossed "NP" (closed P) with a partial bisect on one side and "15" on the other. NDC 68382-797-01 – Bottle of 100 Tablets DEA Order Form Required Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure. Protect from moisture. Store at 25°C (77°F); excursions are permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Store oxycodone HCl securely and dispose of properly [see Patient Counseling Information (17)] .
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