Oxycodone 5 mg
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, which can occur at any dosage or duration [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 should not be used for an extended period of time unless the pain remains severe enough to require an opioid analgesic and for which alternative treatment options continue to be inadequate. 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: Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration, reserve oxycodone hydrochloride tablets for use in patients for whom alternative treatment options (e.g., non-opioidanalgesics 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. Oxycodone hydrochloride tablets should not be used for an extended period of time unless the pain remains severe enough to require an opioid analgesic and for which alternative treatment options continue to be inadequate.
Alvogen, Inc.
ROUND WHITE ALG 263
ALG 263 ROUND WHITE
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16 HOW SUPPLIED/STORAGE AND HANDLING
OXYCODONE HYDROCHLORIDE tablets, USP are available as follows: 5 mg tablets: white, round, biconvex tablets debossed “ALG 263” on one side and score line on the other side. Bottles of 500 tablets: NDC 47781-263-05 Bottles of 100 tablets: NDC 47781-263-01 15 mg tablets: green, round, biconvex tablets, debossed “ALG 264” on one side and score line on the other side. Bottles of 500 tablets: NDC 47781-264-05 Bottles of 100 tablets: NDC 47781-264-01 30 mg tablets: blue, round, biconvex tablets, debossed “ALG 265” on one side and score line on the other side. Bottles of 500 tablets: NDC 47781-265-05 Bottles of 100 tablets: NDC 47781-265-01 DEA Order Form Required Dispense in a tight, light-resistant container. Protect from moisture. Store at 25°C (77°F); excursions are permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. Store
OXYCODONE HYDROCHLORIDE tablets securely and dispose of properly [see Patient Counseling Information ( 17 )] .
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