Hydrocodone HCL bitartrate and acetaminophen are supplied in tablet form for oral administration.
Hydrocodone HCL 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: 4,5a- 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, odourless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula:
Hydrocodone bitartrate and acetaminophen tablets, USP for oral administration are available in the following strengths
|2.5 mg/500 mg||2.5 mg||500 mg|
|5 mg / 500 mg||5 mg||500 mg|
|7.5 mg / 325 mg||7.5 mg||325 mg|
|7.5 mg / 500 mg||7.5 mg||500 mg|
|7.5 mg / 650 mg||7.5 mg||650 mg|
|7.5 mg / 750 mg||7.5 mg||750 mg|
|10 mg / 325 mg||10 mg||325 mg|
|10 mg / 500 mg||10 mg||500 mg|
|10 mg / 650 mg||10 mg||650 mg|
|10 mg / 660 mg||10 mg||660 mg|
|10 mg / 750 mg||10 mg||750 mg|
In addition, each tablet contains the following inactive ingredients: anhydrous lactose, croscarmellose sodium, crospovidone, magnesium stearate,microcrystalline cellulose, povidone, starch, and stearic acid; except the 7.5mg/325mg, 10 mg/325 mg and 10 mg/500 mg tablets do not contain anhydrous lactose. The 7.5 mg/325 mg tablets include FD and C Yellow # 6 Aluminum Lake; the 7.5 mg/650 mg tablets include FD and C Red #40 Aluminum Lake; the 10 mg/325 mg and 10 mg/750 mg tablets include D and C Yellow # 10 Aluminum Lake; the 10 mg/500 mg tablets include FD and C Blue #2 Aluminum Lake; and the 10 mg/650mg tablets include FD and C Blue #1 Aluminum Lake and D and C Yellow #10 Aluminum Lake. Meets USP Dissolution Test 1.