Acetaminophen 325 MG Hydrocodone Bitartrate 5 MG
INDICATIONS AND USAGE Hydrocodone bitartrate and acetaminophen tablets, USP 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, even at recommended doses [see WARNINGS ], reserve hydrocodone bitartrate and acetaminophen tablets, USP 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
camber pharmaceuticals, inc.
OVAL WHITE T257
T257 OVAL WHITE
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HOW SUPPLIED
HYDROCODONE BITARTRATE AND ACETAMINOPHEN Tablets, USP are supplied as 2.5 mg/325 mg containing 2.5 mg hydrocodone bitartrate and 325 mg acetaminophen. Off white/white capsule shaped tablet debossed ‘T 256’ on one side and plain on other side. NDC 31722-940-01, Bottles of 100 Tablets 5 mg/325 mg containing 5 mg hydrocodone bitartrate and 325 mg acetaminophen. Off white, with orange specks, capsule shaped tablet debossed ‘T 257’ on one side and plain on other side with bisect line. NDC 31722-941-01, Bottles of 100 Tablets NDC 31722-941-05, Bottles of 500 Tablets 7.5 mg/325 mg containing 7.5 mg hydrocodone bitartrate and 325 mg acetaminophen. Off white/white capsule shaped tablet debossed ‘T 258’ on one side and plain on other side with bisect line. NDC 31722-942-01, Bottles of 100 Tablets NDC 31722-942-05, Bottles of 500 Tablets 10 mg/325 mg containing 10 mg hydrocodone bitartrate and 325 mg acetaminophen. Light yellow to yellow color capsule shaped tablet debossed ‘T 259’ on one side and plain on other side with bisect line. NDC 31722-943-01, Bottles of 100 Tablets NDC 31722-943-05, Bottles of 500 Tablets 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 ]. Manufactured by: Ascent Pharmaceuticals, Inc. Central Islip, NY 11722 Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854 Revised: 05/21
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