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LORCET: (hydrocodone bitartrate and acetaminophen) Tablets
Hydrocodone bitartrate and acetaminophen are 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: 4,5 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 antipyretic.
Acetaminophen Structural Formula Illustration
Each Lorcet® 10/650 tablet for oral administration contains:
Hydrocodone Bitartrate………………………….10 mg
WARNING: May be habit-forming.
In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, crospovidone, microcrystalline cellulose, povidone, pregelatinized starch, stearic acid and FD&C Blue #1 Lake.
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.
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
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.