Each Orphenadrine Citrate, Aspirin and Caffeine 25 mg/385 mg/30 mg Tablet intended for oral administration contains orphenadrine citrate 25 mg, aspirin 385 mg, and caffeine 30 mg. Each Orphenadrine Citrate, Aspirin and Caffeine 50 mg/770 mg/60 mg tablet intended for oral administration contains orphenadrine citrate 50 mg, aspirin 770 mg, and caffeine 60 mg.

Orphenadrine Citrate, Aspirin and Caffeine 25 mg/385 mg/30 mg and Orphenadrine Citrate, Aspirin and Caffeine 50 mg/770 mg/60 mg Tablets also contain the following inactive ingredients: corn starch, croscarmellose sodium, D&C Yellow No.10 aluminum lake, FD&C Blue No.1 aluminum lake, lactose monohydrate, magnesium stearate, povidone and silicon dioxide.

Orphenadrine citrate is the citrate salt of orphenadrine. It occurs as a white, crystalline powder having a bitter taste. It is practically odorless; sparingly soluble in water, slightly soluble in alcohol. The chemical name of orphenadrine citrate is (±)- N, N- Dimethyl- 2-[( o-methyl-a-phenylbenzyl)oxy] ethylamine citrate (1:1) having molecular formula C₁₈H₂₃NO.C₆H₈O₇ and molecular weight of 461.51.

Caffeine is a central nervous system stimulant which occurs as white powder as white-glistening needles. It is practically odorless and has a bitter taste. It is sparingly soluble in water, alcohol, and freely soluble in chloroform. The chemical name for caffeine is 1,3,7-trimethylxanthine, having a molecular formula C₈H₁₀N₄O₂ and molecular weight of 194.19.

Aspirin salicylic acid acetate, is a non-opiate analgesic, anti-inflammatory and antipyretic agent. It occurs as a white, crystalline tabular or needle and is odorless. The molecular formula for aspirin is C₉H₈O₄ having a molecular weight of 180.16

Orphenadrine Citrate, Aspirin and Caffeine 25 mg/385 mg/30 mg and Orphenadrine Citrate, Aspirin and Caffeine 50 mg/770 mg/60 mg Tablets are indicated in:

1. Symptomatic relief of mild to moderate pain of acute musculoskeletal disorders.

2. 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 25 mg/385 mg/30 mg and Orphenadrine Citrate, Aspirin and Caffeine 50 mg/770 mg/60 mg Tablets do not directly relax tense skeletal muscles in man.

Orphenadrine Citrate, Aspirin and Caffeine 25 mg/385 mg/30 mg Tablets: Adults 1 to 2 tablets 3 to 4 times daily.

Orphenadrine Citrate, Aspirin and Caffeine 50 mg/770 mg/60 mg Tablets: Adults ½ to 1 tablet 3 to 4 times daily.

Orphenadrine Citrate, Aspirin and Caffeine 25 mg/385 mg/30 mg Tablets are green/ white, round, bilayered, compressed, unscored, engraved INV over 265 on one side and are supplied as follows:

NDC 62269-265-24 in bottles of 100 tablets

NDC 62269-265-29 in bottles of 500 tablets

Orphenadrine Citrate, Aspirin and Caffeine 50 mg/770 mg/60 mg Tablets are green/white, capsule shaped, bi-layered, compressed, engraved INV to the left and 266 to the right of the bisect on one side and are supplied as follows:

NDC 62269-266-24 in bottles of 100 tablets

NDC 62269-266-29 in bottles of 500 tablets.

Store below 30°C (86°F). Protect from moisture.

Dispense in a tight, light-resistant container as defined in the USP.

CAUTION: Federal law prohibits dispensing without prescription.

Side effects of Orphenadrine Citrate, Aspirin and Caffeine 25 mg/385 mg/30 mg or Orphenadrine Citrate, Aspirin and Caffeine 50 mg/770 mg/60 mg Tablets are those seen with aspirin and caffeine or those usually associated with mild anticholinergic agents. These may include tachycardia, palpitation, urinary hesitancy or retention, dry mouth, blurred vision, dilatation of the pupil, increased intraocular tension, weakness, nausea, vomiting, headache, dizziness, constipation, drowsiness, and rarely, urticaria and other dermatoses. 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 25 mg/385 mg/30 mg Tablets 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 25 mg/385 mg/30 mg or Orphenadrine Citrate, Aspirin and Caffeine 50 mg/770 mg/60 mg Tablets. Some patients may experience transient episodes of lightheadedness, dizziness or syncope.

No information provided.

Reye's Syndrome may develop in individuals who have chicken pox, influenza, or flu symptoms. Some studies suggest a possible association between the development of Reye's Syndrome and the use of medicines containing salicylate or aspirin. Orphenadrine Citrate, Aspirin and Caffeine 25 mg/385 mg/30 mg and Orphenadrine Citrate, Aspirin and Caffeine 50 mg/770 mg/60 mg Tablets contain aspirin and therefore are not recommended for use in patients with chicken pox, influenza, or flu symptoms.

Orphenadrine Citrate, Aspirin and Caffeine 25 mg/385 mg/30 mg and Orphenadrine Citrate, Aspirin and Caffeine 50 mg/770 mg/60 mg Tablets may impair the ability of the patient to engage in potentially hazardous activities such as operating machinery or driving a motor vehicle; ambulatory patients should therefore be cautioned accordingly.

Aspirin should be used with extreme caution in the presence of peptic ulcers and coagulation abnormalities.

Usage in Pregnancy: Since safety of the use of this preparation in pregnancy, during lactation, or in the child bearing age has not been established, use of the drug in such patients requires that the potential benefits of the drug be weighed against the hazard to the mother and child.

Usage in Children: The safe and effective use of this drug in children has not been established. Usage of this drug in children under 12 years of age is not recommended.

Confusion, anxiety and tremors have been reported in a few patients receiving propoxyphene and orphenadrine concomitantly. As these symptoms may be simply due to an additive effect, reduction of dosage and/or discontinuation of one or both agents is recommended in such cases.

Safety of continuous long term therapy with Orphenadrine Citrate, Aspirin and Caffeine 25 mg/385 mg/30 mg and Orphenadrine Citrate, Aspirin and Caffeine 50 mg/770 mg/60 mg Tablets has not been established; therefore, if Orphenadrine Citrate, Aspirin and Caffeine 25 mg/385 mg/30 mg or Orphenadrine Citrate, Aspirin and Caffeine 50 mg/770 mg/60 mg Tablets is prescribed for prolonged use, periodic monitoring of blood, urine and liver function values is recommended.

No information provided.

Because of the mild anticholinergic effect of orphenadrine, Orphenadrine Citrate, Aspirin and Caffeine 25 mg/385 mg/30 mg or Orphenadrine Citrate, Aspirin and Caffeine 50 mg/770 mg/60 mg 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 25 mg/385 mg/30 mg or Orphenadrine Citrate, Aspirin and Caffeine 50 mg/770 mg/60 mg 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.

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 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 related to its analgesic properties. Orphenadrine citrate also possesses anticholinergic actions.

See WARNINGS, PRECAUTIONS and CONTRAINDICATIONS.