hydrocodone bitartrate 10 mg acetaminophen 300 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.
aurolife pharma, llc
OVAL WHITE U116
U116 OVAL WHITE
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HOW SUPPLIED
HYDROCODONE BITARTRATE AND ACETAMINOPHEN Tablets USP are supplied as follows:
HYDROCODONE BITARTRATE AND ACETAMINOPHEN Tablets USP, 5 mg/300 mg are white to off-white, uncoated, capsule shaped tablets, debossed with “U114” on one side and “breakline” on the other side. Bottles of 30 NDC 13107-211-30 Bottles of 100 NDC 13107-211-01 Bottles of 500 NDC 13107-211-05 Bottles of 1,000 NDC 13107-211-99
HYDROCODONE BITARTRATE AND ACETAMINOPHEN Tablets USP, 7.5 mg/300 mg are white to off-white, uncoated, oval shaped tablets, debossed with “U115” on one side and “breakline” on the other side. Bottles of 30 NDC 13107-212-30 Bottles of 100 NDC 13107-212-01 Bottles of 500 NDC 13107-212-05 Bottles of 1,000 NDC 13107-212-99
HYDROCODONE BITARTRATE AND ACETAMINOPHEN Tablets USP, 10 mg/300 mg are white to off-white, uncoated, capsule shaped tablets, debossed with “U116” on one side and “breakline” on the other side. Bottles of 30 NDC 13107-213-30 Bottles of 100 NDC 13107-213-01 Bottles of 500 NDC 13107-213-05 Bottles of 1,000 NDC 13107-213-99 STORAGE: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Store
HYDROCODONE BITARTRATE AND ACETAMINOPHEN Tablets securely and dispose of properly [see PRECAUTIONS / Information for Patients ]. Dispense in a tight, light resistant container as defined in the USP with a child-resistant closure A Schedule II Narcotic Dispense with Medication Guide available at https://www.aurobindousa.com/medication-guides/ Distributed by: Aurobindo Pharma USA, Inc 279 Princeton-Hightstown Road East Windsor, NJ 08520 Revised: 08/2020
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