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.
SpecGx LLC
OVAL WHITE M376
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HOW SUPPLIED
HYDROCODONE BITARTRATE AND ACETAMINOPHEN Tablets USP are supplied as follows:
HYDROCODONE BITARTRATE AND ACETAMINOPHEN Tablets USP 5 mg/300 mg Modified white, oval tablet debossed “M376” on one side and a bisect on the other: Bottles of 100 ……………NDC 0406-0376-01 Bottles of 500 ……………NDC 0406-0376-05 Unit Dose (10 x 10) ……..NDC 0406-0376-62
HYDROCODONE BITARTRATE AND ACETAMINOPHEN Tablets USP 7.5 mg/300 mg Modified white, oval tablet debossed “M377” on one side and a bisect on the other: Bottles of 100 ……………NDC 0406-0377-01 Bottles of 500 ……………NDC 0406-0377-05 Unit Dose (10 x 10) ……..NDC 0406-0377-62
HYDROCODONE BITARTRATE AND ACETAMINOPHEN Tablets USP 10 mg/300 mg Modified white, oval tablet debossed “M378” on one side and a bisect on the other: Bottles of 100 ……………NDC 0406-0378-01 Bottles of 500 ……………NDC 0406-0378-05 Unit Dose (10 x 10) ……..NDC 0406-0378-62 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 the 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. Manufactured for: 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/MG20H30.pdf or by calling 1-800-778-7898 for alternate delivery options.
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