Acetaminophen 325 MG Oxycodone Hydrochloride 5 MG Oral Tablet
INDICATIONS AND USAGE Oxycodone 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 oxycodone 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. Oxycodone 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
ROUND WHITE 512
512 ROUND WHITE
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HOW SUPPLIED Each oxycodone and acetaminophen tablet USP 5 mg/325 mg contains oxycodone hydrochloride 5 mg (equivalent to 4.4815 mg oxycodone) and acetaminophen 325 mg. It is available as a round, white scored tablet debossed with a 512 identification number. Bottles of 100.................................... NDC 0406-0512-01 Bottles of 500.................................... NDC 0406-0512-05 Unit Dose (10 x 10).......................... NDC 0406-0512-62 Each oxycodone and acetaminophen tablet USP 7.5 mg/325 mg contains oxycodone hydrochloride 7.5 mg (equivalent to 6.7228 mg oxycodone) and acetaminophen 325 mg. It is available as a white to off-white caplet shaped tablet debossed with “M522” on one side and “7.5/325” on the other side. Bottles of 100.................................... NDC 0406-0522-01 Bottles of 500.................................... NDC 0406-0522-05 Unit Dose (10 x 10).......................... NDC 0406-0522-62 Each oxycodone and acetaminophen tablet USP 10 mg/325 mg contains oxycodone hydrochloride 10 mg (equivalent to 8.9637 mg oxycodone) and acetaminophen 325 mg. It is available as a white to off-white caplet shaped tablet debossed with “M523” on one side and “10/325” on the other side. Bottles of 100.................................... NDC 0406-0523-01 Bottles of 500.................................... NDC 0406-0523-05 Unit Dose (10 x 10).......................... NDC 0406-0523-62 Storage Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Store oxycodone 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 03/2024 Mallinckrodt™ Pharmaceuticals An electronic copy of this medication guide can be obtained from www.mallinckrodt.com/Medguide/MG20O10.pdf or by calling 1-800-778-7898 for alternate delivery options.
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