Label: ORPHENADRINE CITRATE ASPIRIN CAFFEINE- orphenadrine citrate, aspirin, caffeine tablet

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 the regular formula 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.

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. These products do not directly relax tense skeletal muscles in man.

Because of the mild anticholinergic effect of orphenadrine, these products should not be used in patients with glaucoma, pyloric or duodenal obstruction, achalasia, prostatic hypertrophy or obstructions at the bladder neck. These products 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.

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. These products contain aspirin and therefore are not recommended for use in patients with chicken pox, influenza, or flu symptoms.

These products 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 extra caution in the presence of peptic ulcers and coagulation abnormalities.

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 simple 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 these products has not been established; therefore, if they are prescribed for prolonged use, periodic monitoring of blood, urine and liver function values is recommended.

Side effects of these products 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, dilation 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 the regular formula has been reported. No causal relationship has been established. Rare G.I. hemorrhage due to aspirin content may be associated with the administration of these products. Some patients may experience transient episodes of lightheadedness, 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).

To report SUSPECTED ADVERSE REACTIONS, contact Jerome Stevens Pharmaceuticals Inc. at 1-844-686-1019 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

REGULAR: Adults 1 to 2 tablets 3 to 4 times daily.

FORTE: Adults ½ to 1 tablet 3 to 4 times daily.

Regular tablets can be identified as a round, multi-layered tablet embossed JSP 554 on one side, and contains orphenadrine citrate (2-dimethylaminoethyl 2-methylbenzhydryl ether citrate) 25 mg, aspirin 385 mg, and caffeine 30 mg.

Forte tablets are exactly twice the strength of the regular. They are identified by their scored capsule shape. Each multi-layered tablet is embossed JSP 555 on one side and contains orphenadrine citrate 50 mg, aspirin 770 mg, and caffeine 60 mg.

Products also contain: lactose, starch, D&C yellow #10 and FD&C blue #1.

Regular: Bottles of

Forte: Bottles of

Store below 30°C (86°F)

JSP INC.

NDC 50564-554-01

ORPHENADRINE CITRATE,
ASPIRIN, CAFFEINE

Caution: Federal law prohibits
dispensing without prescription.

100 TABLETS

JSP INC.

NDC 50564-555-01

ORPHENADRINE CITRATE,
ASPIRIN, CAFFEINE
FORTE

Caution: Federal law prohibits
dispensing without prescription.

100 TABLETS