Acetaminophen 300 MG Hydrocodone Bitartrate 5 MG Oral 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

Novel Laboratories, Inc.

FDA Reported Adverse Reactions
`[1] drug dependence` `[2] pain` `[3] drug ineffective` `[4] overdose` `[5] fatigue` `[6] emotional distress` `[7] off label use` `[8] rash` `[9] nausea` `[10] headache`

4 years ago

CAPSULE WHITE n 351

4 years ago

n 351 CAPSULE WHITE

HOW SUPPLIED

HYDROCODONE BITARTRATE AND ACETAMINOPHEN Tablets, USP 5 mg/300 mg are available as white, capsule-shaped, bisected tablets, debossed "n" score "351" on one side and plain on the other side. They are supplied as follows: Bottles of 30 40032-351-03 Bottles of 100 40032-351-01 Bottles of 500 40032-351-05

HYDROCODONE BITARTRATE AND ACETAMINOPHEN Tablets USP, 7.5 mg/300 mg are available as white, capsule-shaped, bisected tablets, debossed "n" score "352" on one side and plain on the other side. They are supplied as follows: Bottles of 30 40032-352-03 Bottles of 100 40032-352-01 Bottles of 500 40032-352-05

HYDROCODONE BITARTRATE AND ACETAMINOPHEN Tablets USP, 10 mg/300 mg are available as white, capsule-shaped, bisected tablets, debossed "n" score "353" on one side and plain on the other side. They are supplied as follows: Bottles of 30 40032-353-03 Bottles of 100 40032-353-01 Bottles of 500 40032-353-05 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 ] Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 PI3530000109 Revised 09/2019

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