tablets 25 mg/ 385 mg/ 30 mg · Atland Pharmaceuticals, LLC
Dosage Form
tablets 25 mg/ 385 mg/ 30 mg
Manufacturer
Atland Pharmaceuticals, LLC
This medication contains important usage instructions, warnings, and side effect information that you should review before use.
Orphenadrine Citrate, Aspirin and Caffeine 25 mg/ 385 mg/ 30 mg Tablets are indicated in:
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.
Orphenadrine Citrate, Aspirin and Caffeine Tablets: Adults 1 to 2 tablet 3 to 4 times daily.
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 contraindicated in patients who have demonstrated a previous hypersensitivity to the drug.
Side effects of Orphenadrine Citrate, Aspirin and Caffeine Tablets are those seen with aspirin and caffeine or those usually associated with mild anti-cholinergic agents. These may include tachycardia, palpitation, urinary hesitancy or retention, dry mouth, blurred vision, dilation of the pupil, increased intraocular tension, weakness, nausea, vomiting, headache, dizziness, constipation, drowsiness, and rarely, urticaria and other dermatosis. Infrequently, an elderly patient may experience some degree of confusion. Mild central excitation and occasional hallucinations may be observed. These mild side effects can usually be eliminated by reduction in dosage. One case of aplastic anemia associated with the use of orphenadrine citrate, aspirin and caffeine has been reported. No causal relationship has been established. Rare G.I. hemorrhage due to aspirin content may be associated with the administration of Orphenadrine Citrate, Aspirin and Caffeine Tablets. Some patients may experience transient episodes of light-headedness, dizziness or syncope.
Orphenadrine Citrate, Aspirin and Caffeine Tablets may also cause exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), toxic epidermal necrosis (TEN), and fixed drug eruption (FDE) ( see WARNINGS ).
Each Orphenadrine Citrate, Aspirin and Caffeine Tablet, for oral administration contains Orphenadrine Citrate 25 mg, Aspirin 385 mg and Caffeine 30 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:
[image: MM2]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:
[image: MM3]Orphenadrine Citrate, Aspirin, and Caffeine Tablets (Orphenadrine Citrate 25 mg, Aspirin 385 mg, and Caffeine 30 mg): Two-layered, white/green round flat faced beveled edge tablet debossed “OAC” over “472” on the white side and plain on the green side. They are available in bottles of 60 tablets (NDC 71993-304-60).
Store below 30°C (86°F)
Rx Only
Manufactured for:
ATLAND Pharmaceuticals, LLC
Sylacauga, AL 35150
201132-01
Rev. 09/2025
Photos of the product and/or packaging supplied by the manufacturer.
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 pathological changes detected. Extensive experience with combinations containing aspirin and caffeine has established them as safe agents. The addition of orphenadrine citrate does not alter the toxicity of aspirin and caffeine.
The mode of therapeutic action of orphenadrine has not been clearly identified, but may be relegated to its analgesic properties. Orphenadrine citrate also possesses anti-cholinergic actions.
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