DailyMed Label: Orphenadrine Citrate Aspirin Caffeine

DailyMed Label: Orphenadrine Citrate Aspirin Caffeine

2021

DailyMed Prescription

Orphenadrine Citrate Aspirin Caffeine

Orphenadrine Citrate, Aspirin, Caffeine

Jerome Stevens Pharmaceuticals, Inc.

NDC: 50564-554

NDC: 50564-554

NDC: 50564-555

NDC: 50564-555

NDC: 50564-554

NDC: 50564-554

NDC: 50564-555

NDC: 50564-555

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

REGULAR: Adults 1 to 2 tablets 3 to 4 times daily. FORTE: Adults ½ to 1 tablet 3 to 4 times daily.

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.

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. Inform pregnant women to avoid use of aspirin and other NSAIDs starting at 30 weeks gestation because of the risk of the premature closing of the fetal ductus arteriosus. If treatment with Orphenadrine Citrate Aspirin Caffeine Regular and Forte Tablets is needed for a pregnant woman between about 20 to 30 weeks gestation, advise her that she may need to be monitored for oligohydramnios, if treatment continues for longer than 48 hours [see WARNINGS; Fetal Toxicity , PRECAUTIONS; Pregnancy ]. Advise patients to stop taking Orphenadrine Citrate Aspirin Caffeine Regular and Forte Tablets immediately if they develop any type of rash or fever and to contact their healthcare provider as soon as possible [see Warnings ].

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.

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      100 tablets NDC 50564-554-01      500 tablets NDC 50564-554-05 Forte: Bottles of      100 tablets NDC 50564-555-01      500 tablets NDC 50564-555-05 Store below 30°C (86°F) Caution: Federal law prohibits dispensing without prescription. Manufactured by: Jerome Stevens Pharmaceuticals, Inc. Bohemia, NY 11716 Rev. 03/21 MG # 11584

JSP INC. NDC 50564-554-01 ORPHENADRINE CITRATE, ASPIRIN, CAFFEINE Caution: Federal law prohibits dispensing without prescription. 100 TABLETS Principal Display Panel - 25 mg Bottle Label