Description

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NORCO® 10/325 mg:(hydrocodone bitartrate and acetaminophen) Tablets USP 10/325 mg

DESCRIPTION
NORCO® (Hydrocodone bitartrate and acetaminophen) is supplied in tablet form for oral administration.

Hydrocodone bitartrate is an opioid analgesic and antitussive 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).

Hydrocodone bitartrate – Structural Formula Illustration
Acetaminophen, 4´-Hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non opiate, non-salicylate analgesic and antipyretic.

Acetaminophen – Structural Formula Illustration
Each NORCO® 10/325 tablet contains:

Hydrocodone Bitartrate……10 mg
Acetaminophen…………..325 mg

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In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, crospovidone, microcrystalline cellulose, povidone, pregelatinized starch, stearic acid and sugar spheres which are composed of starch derived from corn, sucrose, and FD&C Yellow #6.

INDICATIONS
NORCO is indicated for the relief of moderate to moderately severe pain.

DOSAGE AND ADMINISTRATION
Dosage should be adjusted according to the severity of the pain and the response of the patient. However, it should be kept in mind that tolerance to hydrocodone can develop with continued use and that the incidence of untoward effects is dose related.

The usual adult dosage is one or two tablets every four to six hours as needed for pain. The total daily dosage should not exceed 8 tablets.

HOW SUPPLIED
NORCO® 10/325 tablets (Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/325 mg) contain hydrocodone bitartrate 10 mg and acetaminophen 325 mg. They are supplied as white with orange specks, capsule-shaped, bisected tablets, debossed WATSON on one side and 913 on the other side,

Storage
Store at controlled room temperature 15°-30°C (59°-86°F).
Dispense in a tight, light-resistant container with a *****-resistant closure.