HYDROCODONE BITARTRATE AND ACETAMINOPHEN Acetaminophen 325 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): 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.
Mallinckrodt, Inc.
OVAL WHITE M365
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HOW SUPPLIED
HYDROCODONE BITARTRATE AND ACETAMINOPHEN Tablets USP are supplied as follows: Strength How Supplied Each tablet contains: Description of tablet Hydrocodone Bitartrate Acetaminophen 5 mg/325 mg Bottles of 20 …………..… NDC 0406-0123-20 Bottles of 30 …………..… NDC 0406-0123-30 Bottles of 60 …………..… NDC 0406-0123-60 Bottles of 90 …………..… NDC 0406-0123-90 Bottles of 100 …………… NDC 0406-0123-01 Bottles of 120 ..………..… NDC 0406-0123-12 Bottles of 500 …………… NDC 0406-0123-05 Bottles of 1000 ………..… NDC 0406-0123-10 Unit Dose (10 x 10) …….. NDC 0406-0123-62 5 mg 325 mg It is available as a capsule-shaped white tablet debossed with M365 on one side and bisected on the other side. 7.5 mg/325 mg Bottles of 20 …………..… NDC 0406-0124-20 Bottles of 30 …………..… NDC 0406-0124-30 Bottles of 60 …………..… NDC 0406-0124-60 Bottles of 90 …………..… NDC 0406-0124-90 Bottles of 100 …………… NDC 0406-0124-01 Bottles of 120 ..………..… NDC 0406-0124-12 Bottles of 500 …………… NDC 0406-0124-05 Bottles of 1000 ………..… NDC 0406-0124-10 Unit Dose (10 x 10) …….. NDC 0406-0124-62 7.5 mg 325 mg It is available as an unscored oval-shaped white tablet debossed with M366 on one side. 10 mg/325 mg Bottles of 20 …………..… NDC 0406-0125-20 Bottles of 30 …………..… NDC 0406-0125-30 Bottles of 60 …………..… NDC 0406-0125-60 Bottles of 90 …………..… NDC 0406-0125-90 Bottles of 100 …………… NDC 0406-0125-01 Bottles of 120 ..………..… NDC 0406-0125-12 Bottles of 500 …………… NDC 0406-0125-05 Bottles of 1000 ………..… NDC 0406-0125-10 Unit Dose (10 x 10) …….. NDC 0406-0125-62 10 mg 325 mg It is available as a capsule-shaped white tablet debossed with M367 on one side and bisected on the other side. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light. Dispense in a tight, light-resistant container (as defined in USP) with a child-resistant closure. Store
HYDROCODONE BITARTRATE AND ACETAMINOPHEN tablets securely and dispose of properly ( see PRECAUTIONS, Information for Patients ). Mallinckrodt, the “M” brand mark and the Mallinckrodt Pharmaceuticals logo are trademarks of a Mallinckrodt company. © 2024 Mallinckrodt. SpecGx LLC Webster Groves, MO 63119 USA Rev 01/2024 Mallinckrodt™ Pharmaceuticals An electronic copy of this medication guide can be obtained from www.mallinckrodt.com/Medguide/MG20H32.pdf or by calling 1-800-778-7898 for alternate delivery options.
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