Acetaminophen 325 MG Hydrocodone Bitartrate 10 MG Oral Tablet
INDICATIONS AND USAGE Hydrocodone Bitartrate and Acetaminophen Tablets, USP are indicated for the management of moderate to moderately severe 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, USP 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
sun pharmaceutical industries, inc.
ROUND WHITE RX 497
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HOW SUPPLIED
HYDROCODONE BITARTRATE AND ACETAMINOPHEN Tablets, USP 10 mg/325 mg are available as white to off-white round, uncoated tablets, debossed with “RX” above the bisect and “497” below the bisect on one side and plain on the other side. They are supplied as: NDC 63304-497-03 Bottles of 10 NDC 63304-497-01 Bottles of 100 NDC 63304-497-05 Bottles of 500 NDC 63304-497-10 Bottles of 1000 NDC 63304-497-69 Unit-dose pack of 10 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. To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . Manufactured for Ranbaxy Pharmaceuticals Inc. Jacksonville, FL 32257 USA July 2018 FDA-14
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