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, even at recommended doses [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
Par Pharmaceutical
OVAL WHITE 3604 V
3604 V OVAL WHITE
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HOW SUPPLIED Hydrocodone Bitartrate and Acetaminophen Tablets, USP are supplied as: Hydrocodone Bitartrate and Acetaminophen Tablets, USP 5 mg/325 mg are supplied as white with orange specks, capsule-shaped, scored tablets, debossed “3604” on one side and debossed “V” on the reverse side; and supplied as follows: Bottles of 100: NDC 0603-3890-21 Bottles of 120: NDC 0603-3890-22 Bottles of 500: NDC 0603-3890-28 Bottles of 1000: NDC 0603-3890-32 Hydrocodone Bitartrate and Acetaminophen Tablets, USP 7.5 mg/325 mg are supplied as light orange, oval-shaped, scored tablets, debossed “3605” on one side and debossed “V” on the reverse side; and supplied as follows: Bottles of 100: NDC 0603-3891-21 Bottles of 120: NDC 0603-3891-22 Bottles of 500: NDC 0603-3891-28 Bottles of 1000: NDC 0603-3891-32 Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/325 mg are supplied as light yellow, modified capsule-shaped, scored tablets, debossed “3601” on one side and debossed “V” on the reverse side; and supplied as follows: Bottles of 100: NDC 0603-3887-21 Bottles of 120: NDC 0603-3887-22 Bottles of 500: NDC 0603-3887-28 Bottles of 1000: NDC 0603-3887-32 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 ].
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