Oxycodone 5 mg Acetaminophen 325 mg
INDICATIONS AND USAGE Oxycodone and acetaminophen 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], reserve oxycodone and acetaminophen tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics] · 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 and acetaminophen 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.
Aurolife Pharma LLC
OVAL WHITE U15
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HOW SUPPLIED
OXYCODONE AND ACETAMINOPHEN Tablets, USP are supplied as follows: 2.5 mg/325 mg white to off-white, round tablets, debossed with “U14” on one side and plain on the other side. Bottles of 30 NDC 13107-043-30 Bottles of 100 NDC 13107-043-01 Bottles of 500 NDC 13107-043-05 Bottles of 1000 NDC 13107-043-99 5 mg/325 mg white to off-white, capsule-shaped tablets, debossed with “U15” on one side and break line on the other side. Bottles of 30 NDC 13107-044-30 Bottles of 100 NDC 13107-044-01 Bottles of 500 NDC 13107-044-05 Bottles of 1000 NDC 13107-044-99 7.5 mg/325 mg white to off-white, oval-shaped tablets, debossed with “U16” on one side and plain on the other side. Bottles of 30 NDC 13107-045-30 Bottles of 100 NDC 13107-045-01 Bottles of 500 NDC 13107-045-05 Bottles of 1000 NDC 13107-045-99 10 mg/325 mg white to off-white, capsule-shaped tablets, debossed with “U17” on one side and plain on the other side. Bottles of 30 NDC 13107-046-30 Bottles of 100 NDC 13107-046-01 Bottles of 500 NDC 13107-046-05 Bottles of 1000 NDC 13107-046-99 Store at 20° to 25°C (68° to 77°F). [see USP Controlled Room Temperature]. Store
OXYCODONE AND ACETAMINOPHEN Tablets securely and dispose of properly [see PRECAUTIONS/ Information for Patients]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). DEA Order Form Required. Dispense with Medication Guide available at https://www.aurobindousa.com/medication-guides/ Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Revised: 03/2024
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