Acetaminophen 500 mg hydrocodone bitartrate 5 mg
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
sun pharmaceutical industries, inc.
OVAL YELLOW 691
691 OVAL YELLOW
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How Supplied/Storage and Handling Hydrocodone Bitartrate and Acetaminophen Tablets, USP are supplied as: 5 mg/325 mg: white to off-white, capsule-shaped, biconvex, uncoated tablets debossed with ‘126’ on one side and scored on the other side. Each tablet contains 5 mg of hydrocodone bitartrate, USP and 325 mg of acetaminophen, USP. They are supplied as follows: NDC 57664-126-83 Bottles of 30 CRC NDC 57664-126-88 Bottles of 100 CRC NDC 57664-126-08 Bottles of 100 NDC 57664-126-13 Bottles of 500 NDC 57664-126-18 Bottles of 1000 7.5 mg/325 mg : yellow colored, oval-shaped, biconvex, uncoated tablets debossed with ‘170’ on one side and scored on the other side. Each tablet contains 7.5 mg of hydrocodone bitartrate, USP and 325 mg of acetaminophen, USP. They are supplied as follows: NDC 57664-170-83 Bottles of 30 CRC NDC 57664-170-88 Bottles of 100 CRC NDC 57664-170-08 Bottles of 100 NDC 57664-170-13 Bottles of 500 NDC 57664-170-18 Bottles of 1000 10 mg/325 mg: white to off-white, oval-shaped, biconvex, uncoated tablets debossed with ‘176’ on one side and scored on the other side. Each tablet contains 10 mg of hydrocodone bitartrate, USP and 325 mg of acetaminophen, USP. They are supplied as follows: NDC 57664-176-83 Bottles of 30 CRC NDC 57664-176-88 Bottles of 100 CRC NDC 57664-176-08 Bottles of 100 NDC 57664-176-13 Bottles of 500 NDC 57664-176-18 Bottles of 1000 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]. A Schedule CII Controlled Drug Substance. DEA ORDER FORM REQUIRED Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 Rev. 08/2020
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