Acetaminophen 300 MG Hydrocodone Bitartrate 10 MG Oral Tablet
INDICATIONS AND USAGE Hydrocodone Bitartrate 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 Hydrocodone Bitartrate 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 Hydrocodone Bitartrate 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.
Amneal Pharmaceuticals LLC
OVAL WHITE AN 10
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HOW SUPPLIED
HYDROCODONE BITARTRATE AND ACETAMINOPHEN Tablets USP, 10 mg/300 mg, are supplied as white to off-white, scored, capsule-shaped tablets, debossed “AN 10” with bisect on one side and plain on the other side. They are available as follows: Bottles of 100: NDC 65162-696-10 Bottles of 500: NDC 65162-696-50 Bottles of 1,000: NDC 65162-696-11 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closure. A Schedule II Narcotic DEA Order Form Required. Store
HYDROCODONE BITARTRATE AND ACETAMINOPHEN Tablets securely and dispose of properly [see PRECAUTIONS; Information for Patients ]. Manufactured by: Amneal Pharmaceuticals of NY, LLC Brookhaven, NY 11719 Rev. 01-2024-09 Dispense with Medication Guide available at: documents.amneal.com/mg/hydrocodone-apap-10-300.pdf
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