Description

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VICODIN®
VICODIN ES®
VICODIN HP®
(Hydrocodone Bitartrate and Acetaminophen) tablets

DESCRIPTION
Hydrocodone bitartrate and acetaminophen are available in tablet form for oral administration.

Hydrocodone bitartrate is an opioid analgesic and occurs as fine, white crystals or as a crystalline powder. It is affected by light. The chemical name is 4,5α-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It has the following structural formula:

Hydrocodone bitartrate – Structural Formula Illustration
Acetaminophen, 4’ -hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula:

Acetaminophen – Structural Formula Illustration
Each VICODIN® (Hydrocodone Bitartrate and Acetaminophen Tablets, USP 5 mg/300 mg) contains:

Hydrocodone Bitartrate…………5 mg
Acetaminophen………………….300 mg

Also, each tablet contains the following inactive ingredients: colloidal silicon dioxide, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, and stearic acid.

INDICATIONS
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.

Initial Dosage
Initiating Treatment With Hydrocodone Bitartrate And Acetaminophen Tablets
VICODIN®5 mg/300 mg:
The usual adult dosage is one or two tablets every four to six hours as needed for
pain.

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HOW SUPPLIED
VICODIN®, VICODIN ES®, and VICODIN HP® (Hydrocodone Bitartrate and Acetaminophen) Tablets, USP are supplied as:
VICODIN® 5 mg/300 mg
White, capsule-shaped, bisected tablets debossed “5” score “300” on one side and “VICODIN” on the other side in bottles of 100 and 500 tablets:

Limitations Of Use
Because of the risks of addiction, *****, 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