Drug Catalog - Product Detail
NORGESIC FORTE TAB 50-770-60 MG 60 EA
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 50991-0999-60 | POLY PHARMACEUTICALS | 60 | 50-770-60MG | TABLET |
PACKAGE FILES
Generic Name
ORPHENADRINE CITRATE, ASPIRIN AND CAFFEINE
Substance Name
ASPIRIN
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA075141
Description
DESCRIPTION Each Norgesic Forte tablet, for oral administration, contains Orphenadrine Citrate 50 mg, Aspirin 770 mg, Caffeine 60 mg. In addition, each tablet contains the following inactive ingredients, anhydrous lactous, colloidal silicon dioxide, D&C yellow #10, FD&C blue #1, zinc stearate, providone, pregetanized starch, and stearic acid. Orphenadrine citrate, (2-dimethylaminoethyl 2-methybenzhydryl ether citrate). It is as a white, practically odorless, crystalline powder, having a bitter taste. It is sparingly soluble in water, slightly soluble in alcohol. It has the following structural formula: Aspirin, salicylic acid acetate, is a non-opiate analgesic, anti-inflammatory and antipyretic agent. It occurs as a white, crystalline tabular or needle like powder and is odorless or has a faint odor. It is sparingly soluble in water, freely soluble in alcohol and chloroform. It has the following structural formula: Caffeine is a central nervous system stimulant which occurs as a white powder or white glistening needles, usually matted together. It is sparingly soluble in alcohol, and freely soluble in chloroform. The chemical name for caffeine is 1,3,7-Trimethylxanthine. It has the following structural formula: formula1 formula2 formula3
How Supplied
HOW SUPPLIED Norgesic Forte Tablets (Orphenadrine Citrate 50mg, Aspirin 770mg, and Caffeine 60mg) Two-layered, white/green capsule shaped, bisected tablets debossed "GA" and "473" with bisect on the white side and plain on the green side are available in bottles of 60 tablets (NDC 50991-999-60). Store below 30°C (86°F) Rx Only Storage Store at 20°-25°C (68°-77° F) (see USP Controlled Room Temperature). Protect from moisture.
Indications & Usage
INDICATIONS AND USAGE Norgesic Forte 50 mg/770mg/60 mg Tablets are indicated in: Symptomatic relief of mild to moderate pain of acute musculoskeletal disorders. The orphenadrine component is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute painful musculoskeletal conditions. The mode of action of orphenadrine has not been clearly identified, but may be related to its analgesic properties. Norgesic Forte Tablets do not directly relax tense skeletal muscles in man.
Dosage and Administration
DOSAGE AND ADMINISTRATION Norgesic Forte Tablets: Adults 1/2 to 1 tablet 3 to 4 times daily.