hydrocodone bitartrate and acetaminophen 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.
kvk-tech, inc.
OVAL WHITE A 38
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HOW SUPPLIED
HYDROCODONE BITARTRATE AND ACETAMINOPHEN Tablets, USP are supplied as: 5 mg/300 mg white to off-white, capsule shaped, biconvex tablets, debossed ‘A 41’ with break line on one side and plain on the other side. Bottles of 30 tablets NDC 10702-192-03 Bottles of 100 tablets NDC 10702-192-01 Bottles of 500 tablets NDC 10702-192-50 Bottles of 1000 tablets NDC 10702-192-10 7.5 mg/300 mg white to off-white, capsule shaped, biconvex tablets, debossed ‘A 42’ with break line on one side and plain on the other side. Bottles of 30 tablets NDC 10702-193-03 Bottles of 100 tablets NDC 10702-193-01 Bottles of 500 tablets NDC 10702-193-50 Bottles of 1000 tablets NDC 10702-193-10 10 mg/300 mg white to off-white, capsule shaped, biconvex tablets, debossed ‘A 43’ with break line on one side and plain on the other side. Bottles of 30 tablets NDC 10702-194-03 Bottles of 100 tablets NDC 10702-194-01 Bottles of 500 tablets NDC 10702-194-50 Bottles of 1000 tablets NDC 10702-194-10 5 mg/325 mg white to off-white, capsule shaped, biconvex tablets, debossed ‘A 38’ with break line on one side and plain on the other side. Bottles of 30 tablets NDC 10702-189-03 Bottles of 100 tablets NDC 10702-189-01 Bottles of 500 tablets NDC 10702-189-50 Bottles of 1000 tablets NDC 10702-189-10 7.5 mg/325 mg white to off-white, capsule shaped, biconvex tablets, debossed ‘A 39’ with break line on one side and plain on the other side. Bottles of 30 tablets NDC 10702-190-03 Bottles of 100 tablets NDC 10702-190-01 Bottles of 500 tablets NDC 10702-190-50 Bottles of 1000 tablets NDC 10702-190-10 10 mg/325 mg white to off-white, capsule shaped, biconvex tablets, debossed ‘A 40’ with break line on one side and plain on the other side. Bottles of 30 tablets NDC 10702-191-03 Bottles of 100 tablets NDC 10702-191-01 Bottles of 500 tablets NDC 10702-191-50 Bottles of 1000 tablets NDC 10702-191-10 Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. Store
HYDROCODONE BITARTRATE 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. Manufactured by: KVK-Tech, Inc. 110 Terry Drive Newtown, PA 18940 Item ID #: 6283/11 Rev.: 01/2024 logo
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