Country: United States
Language: English
Source: NLM (National Library of Medicine)
ORPHENADRINE CITRATE (UNII: X0A40N8I4S) (ORPHENADRINE - UNII:AL805O9OG9), ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E), CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)
Atland Pharmaceuticals, LLC
ORAL
PRESCRIPTION DRUG
Orphenadrine Citrate, Aspirin and Caffeine 50 mg/ 770 mg/ 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. Orphenadrine Citrate, Aspirin and Caffeine Tablets do not directly relax tense muscles in man. Because of the mild anticholinergic effect of orphenadrine, Orphenadrine Citrate, Aspirin and Caffeine Tablets should not be used in patients with glaucoma, pyloric or duodenal obstruction, achalasia, prostatic hypertrophy or obstructions at the bladder neck. Orphenadrine Citrate, Aspirin and Caffeine Tablets are also contraindicated in patients with myasthenia gravis and in patients known to be sensitive to aspirin or caffeine. The drug is contrai
Orphenadrine Citrate, Aspirin and Caffeine Tablets (Orphenadrine Citrate 50 mg, Aspirin 770 mg, and Caffeine 60 mg): 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 71993-307-60). Store below 30°C (86°F). Rx Only Manufactured for: ATLAND Pharmaceuticals Sylacauga, AL 35150 500501-03 Rev. 04/2021
Abbreviated New Drug Application
ORPHENADRINE CITRATE, ASPIRIN AND CAFFEINE - ORPHENADRINE CITRATE, ASPIRIN AND CAFFEINE TABLET ATLAND PHARMACEUTICALS, LLC ---------- ORPHENADRINE CITRATE, ASPIRIN AND CAFFEINE TABLETS 50 MG/ 770 MG/ 60 MG USP DESCRIPTION Each Orphenadrine Citrate, Aspirin and Caffeine Tablet, for oral administration contains Orphenadrine Citrate 50 mg, Aspirin 770 mg and Caffeine 60 mg. In addition, each tablet contains the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, D&C yellow #10, FD&C blue #1, zinc stearate, povidone, pregelatinized starch, and stearic acid. Orphenadrine citrate is (2-dimethylaminoethyl 2-methylbenzhydryl ether citrate). It is 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: CLINICAL PHARMACOLOGY Orphenadrine citrate is a centrally acting (brain stem) compound which in animals selectively blocks facilitatory functions of the reticular formation. Orphenadrine does not produce myoneural block, nor does it affect crossed extensor reflexes. Orphenadrine prevents nicotine-induced convulsions but not those produced by strychnine. Chronic administration of Orphenadrine Citrate, Aspirin and Caffeine to dogs and rats has revealed no drug-related toxicity. No blood or urine changes were observed, nor were there any macroscopic or microscopic patholog Read the complete document