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NDC 31722-0997-01

Hydrocodone Bitartrate and Acetaminophen 325 mg/1, 10 mg/1 TABLET

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NDC
31722-0997-01
Generic Name
Hydrocodone Bitartrate and Acetaminophen
Brand Name
Hydrocodone Bitartrate and Acetaminophen
Strength
325 mg/1, 10 mg/1
Dosage Form
TABLET
Route
ORAL
Package Size
—
Labeler
Camber Pharmaceuticals, Inc.

FDA Drug Information

Indications & Usage

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, misuse, overdose, and death which can occur at any dosage or duration and persist over the course of therapy, reserve opioid analgesics, including hydrocodone bitartarate and acetaminophen tablets, for use in patients for whom a…

Important Warnings

WARNINGS Addiction, Abuse, and Misuse Hydrocodone bitartrate and acetaminophen tablets contain hydrocodone, a Schedule II controlled substance. As an opioid, hydrocodone bitartrate and acetaminophen tablets expose users to the risks of addiction, abuse, and misuse [see Drug Abuse and Dependence]. Although the risk of addiction in any individual is unknown, it can occur in patient’s appropriately p…

Source: FDA. For professional use only. Not a substitute for prescribing information.

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