ORPHENADRINE CITRATE, ASPIRIN AND CAFFEINE tablet, multilayer

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ORPHENADRINE CITRATE (UNII: X0A40N8I4S) (ORPHENADRINE - UNII:AL805O9OG9), ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E), CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)

Available from:

Rebel Distributors Corp

INN (International Name):

ORPHENADRINE CITRATE

Composition:

ORPHENADRINE CITRATE 50 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

- 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 skeletal muscles in man. 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 skeletal muscles in man. Because of the mild anti-cholinergic 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 Tab

Product summary:

Orphenadrine Citrate, Aspirin, and Caffeine Tablets, 50 mg/770 mg/60 mg are scored, capsule-shaped, layered tablets colored white and green, imprinted SZ 491 and are supplied as: NDC 21695-726-30 bottles of 30 NDC 21695-726-45 bottles of 45 Store at 20°-25°C (68°-77° F) (see USP Controlled Room Temperature). Protect from moisture.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ORPHENADRINE CITRATE, ASPIRIN AND CAFFEINE- ORPHENADRINE CITRATE,
ASPIRIN AND
CAFFEINE TABLET, MULTILAYER
REBEL DISTRIBUTORS CORP
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ORPHENADRINE CITRATE, ASPIRIN AND CAFFEINE TABLETS
DESCRIPTION
Each tablet, for oral administration, contains Orphenadrine Citrate
USP, 25 mg or 50 mg, Aspirin USP,
385 mg or 770 mg, Caffeine USP, 30 mg or 60 mg.
Orphenadrine citrate, _N_,
_N_-Dimethyl-2-[(o-methyl-α-phenylbenzyl)oxy]ethylamine citrate
(1:1), is a
centrally acting (brain stem) compound. It occurs as a white,
practically odorless, crystalline powder,
having a bitter taste. Its molecular formula is C
H NO.C H O with a molecular weight of 461.51.
The structural formula is shown below.
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. Its
molecular formula is C H O , with a molecular weight of 180.16. The
structural formula is shown
below.
Caffeine, 1,3,7-trimethylxanthine, is a central nervous system
stimulant which occurs as a white powder
or white glistening needles. It also has a bitter taste. Its molecular
formula is C H N O , with a
molecular weight of 194.19. The structural formula is shown below.
Each tablet contains the following inactive ingredients: colloidal
silicon dioxide, corn starch,
croscarmellose sodium, FD&C Blue No. 1, FD&C Yellow No. 10, anhydrous
lactose, microcrystalline
18
23
6
8
7
9
8
4
8
10
4
2
cellulose, povidone, pregelatinized starch, stearic acid, and sodium
lauryl sulfate.
CLINICAL PHARMACOLOGY
Orphenadrine citrate is a centrally acting (brain stem) compound which
in animals selectively blocks
facilitatory functions of the reticular formulation. 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-r