Acetaminophen 300 MG Hydrocodone Bitartrate 5 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 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 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.
Lannett Company, Inc.
OVAL WHITE LCI 16 46
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HOW SUPPLIED
HYDROCODONE BITARTRATE AND ACETAMINOPHEN Tablets, USP are supplied as: 5 mg/300 mg white, capsule-shaped, bisected tablets debossed with “1646” on one side and “LCI” on the other side. Bottle of 100 NDC 0527-1646-01 Bottle of 500 NDC 0527-1646-05 7.5 mg/300 mg white, capsule-shaped, bisected tablets debossed with “1647” on one side and “LCI” on the other side. Bottle of 100 NDC 0527-1647-01 Bottle of 500 NDC 0527-1647-05 10 mg/300 mg white, oval-shaped, bisected tablets debossed with “1648” on one side and “LCI” on the other side. Bottle of 100 NDC 0527-1648-01 Bottle of 500 NDC 0527-1648-05 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. Store
HYDROCODONE BITARTRATE AND ACETAMINOPHEN Tablets securely and dispose of properly [see PRECAUTIONS; Information for Patients ]. Distributed by: Lannett Company, Inc. Philadelphia, PA 19136 CIB71712C Rev. 01/24
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