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, 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, inc.
OVAL WHITE P 36 01
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hydrocodone bitartrate and acetaminophen tablet
par pharmaceutical, inc.
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HOW SUPPLIED Hydrocodone Bitartrate and Acetaminophen Tablets, USP are supplied as follows: Hydrocodone Bitartrate and Acetaminophen Tablets, USP 5 mg/325 mg are supplied as white, capsule shaped tablets containing 5 mg hydrocodone bitartrate ( WARNING: May be habit-forming ) and 325 mg acetaminophen. Tablets are debossed “P” on one side and “36 04” on the other side, and are supplied in bottles of 100 tablets, NDC 0254-2034-01. Hydrocodone Bitartrate and Acetaminophen Tablets, USP 7.5 mg/325 mg are supplied as white, capsule shaped tablets containing 7.5 mg hydrocodone bitartrate ( WARNING: May be habit-forming ) and 325 mg acetaminophen. Tablets are debossed “P” on one side and “36 05” on the other side, and are supplied in bottles of 100 tablets, NDC 0254-2035-01. Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/325 mg are supplied as white, capsule shaped tablets containing 10 mg hydrocodone bitartrate ( WARNING: May be habit-forming ) and 325 mg acetaminophen. Tablets are debossed “P” on one side and “36 01” on the other side, and are supplied in bottles of 100 tablets, NDC 0254-2036-01. Storage and Handling Store at 20°-25°C (68°-77°F). [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container with a child-resistant closure. Store hydrocodone bitartrate and acetaminophen tablets securely and dispose of properly [see PRECAUTIONS; Information for Patients ]. Distributed by: Par Pharmaceutical Chestnut Ridge, NY 10977 Rev. 08/2019
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