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10/650 Lorcet Hydrocodone Acetaminophen

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Hydrocodone acetaminophen and bitartrate are supplied in tablet form for oral administration. It is an opioid analgesic and antitussive and occurs as fine, white crystals or as a crystalline powder. It is affected by light.

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Description

Hydrocodone Acetaminophen

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

It 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: 4,5 a-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 also antipyretic.

Acetaminophen Structural Formula Illustration
Each Lorcet® 10/650 tablet for oral administration contains:

Hydrocodone Bitartrate – 10 mg

WARNING: It may be habit-forming.

Acetaminophen – 650 mg

In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, crospovidone, microcrystalline cellulose, povidone, pregelatinized starch, stearic acid, and also FD&C Blue #1 Lake.

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INDICATIONS

Lorcet® 10/650 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 tablet every four to six hours as needed for pain. The total daily dosage should not exceed 6 tablets.

HOW SUPPLIED

Lorcet® 10/650, Hydrocodone Bitartrate and Acetaminophen Tablets, each tablet of which contains hydrocodone bitartrate 10 mg (WARNING: May be habit-forming) and acetaminophen 650 mg, are light-blue, capsule-shaped, scored tablets, debossed “UAD” on one side and “63 50” on the other side

Storage
Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature].

Dispense in a tight, light-resistant container, with a child-resistant closure.

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