oxycodone and acetaminophen tablet
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
epic pharma, llc
ROUND BLUE E 114
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How Supplied
OXYCODONE AND ACETAMINOPHEN tablets, USP are supplied as follows: The 5 mg/325 mg tablets are blue, round, biconvex tablets debossed “Є114” on one side and bisected on the other side. They are available as follows: Bottles of 100 tablets NDC 42806-114-01 The 7.5 mg/325 mg tablets are orange, oval-shaped, flat-faced beveled edge tablets, debossed “Є115” on one side and plain on the other side. They are available as follows: Bottles of 100 tablets NDC 42806-115-01 The 10 mg/325 mg tablets are yellow, capsule-shaped tablets, debossed “Є116” on one side and plain on the other side. They are available as follows: Bottles of 100 tablets NDC 42806-116-01 Storage Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture, dispense in a tight, light-resistant container as defined in the USP. DEA Order Form Required. Store
OXYCODONE AND ACETAMINOPHEN tablets securely and dispose of properly [see PRECAUTIONS; Information for Patients/Caregivers ]. Dispense with Medication Guide available at: www.epic-pharma.com/medguide/Oxycodone-Acetaminophen-Tablet.pdf Distributed by: Epic Pharma, LLC Laurelton, NY 11413 Rev. 10-2021-00 MF114REV10/21 OE1336
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