DESCRIPTION
Hydrocodone bitartrate and acetaminophen is supplied in tablet form for oral administration. WARNING: May be habit forming (see PRECAUTIONS, Information for Patients, and DRUG ABUSE AND DEPENDENCE).
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(alpha)-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It has the following structural formula:
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:
EACH LORTAB 2.5/500 TABLET CONTAINS:
Hydrocodone Bitartrate.........................2.5 mg
Acetaminophen.....................................500 mg
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 Red #3. Meets USP dissolution test 1.
EACH LORTAB 5/500 TABLET CONTAINS:
Hydrocodone Bitartrate..........................5 mg
Acetaminophen...................................500 mg
In addition, each tablet contains the following inactive ingredients: cornstarch, FD&C Blue # 1 Lake, gelatin, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, sodium starch glycolate, and sugar spheres. Meets USP dissolution test 1.
EACH LORTAB 7.5/500 TABLET CONTAINS:
Hydrocodone Bitartrate........................7.5 mg
Acetaminophen....................................500 mg
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, FD&C Blue #1 and D&C Yellow #10. Meets USP dissolution test 1.
EACH LORTAB 10/500 TABLET CONTAINS:
Hydrocodone Bitartrate..........................10 mg
Acetaminophen....................................500 mg
In addition, each tablet contains the following inactive ingredients: D&C Red No. 27 Aluminum Lake, D&C Red No. 30 Aluminum Lake, colloidal silicon dioxide, croscarmellose sodium, crospovidone, microcrystalline cellulose, povidone, pregelatinized starch, starch (corn), and stearic acid. Meets USP dissolution test 1.
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