Acetaminophen 325 mg Hydrocodone 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, which can occur at any dosage or duration [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. Hydrocodone bitartrate and acetaminophen tablets should not be used for an extended period of time unless the pain remains severe enough to require an opioid analgesic and for which alternative treatment options continue to be inadequate.
Aurolife Pharma LLC
ROUND WHITE U01
U01 ROUND WHITE
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HOW SUPPLIED
HYDROCODONE BITARTRATE AND ACETAMINOPHEN Tablets USP are available in the following strengths:
HYDROCODONE BITARTRATE AND ACETAMINOPHEN Tablet USP, 5 mg/325 mg is available as white to off-white, round tablets, debossed with “U01” on one side and break-line on the other side. Each tablet contains 5 mg hydrocodone bitartrate and 325 mg acetaminophen. Bottles of 30 NDC 13107-019-30 Bottles of 100 NDC 13107-019-01 Bottles of 500 NDC 13107-019-05 Bottles of 1000 NDC 13107-019-99
HYDROCODONE BITARTRATE AND ACETAMINOPHEN Tablet USP, 7.5 mg/325 mg is available as white to off-white, capsule shaped tablets, debossed with “U02” on one side and break-line on the other side. Each tablet contains 7.5 mg hydrocodone bitartrate and 325 mg acetaminophen. Bottles of 30 NDC 13107-020-30 Bottles of 100 NDC 13107-020-01 Bottles of 500 NDC 13107-020-05 Bottles of 1000 NDC 13107-020-99
HYDROCODONE BITARTRATE AND ACETAMINOPHEN Tablet USP, 10 mg/325 mg is available as white to off-white, oval shaped tablets, debossed with “U03” on one side and break-line on the other side. Each tablet contains 10 mg hydrocodone bitartrate and 325 mg acetaminophen. Bottles of 30 NDC 13107-021-30 Bottles of 100 NDC 13107-021-01 Bottles of 500 NDC 13107-021-05 Bottles of 1000 NDC 13107-021-99 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. Keep this and all medication out of the reach of children. A Schedule C-II controlled drug substance. 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: 05/2024
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