Get your patient on Orphenadrine Citrate Aspirin Caffeine - Orphenadrine Citrate, Aspirin, Caffeine tablet (Orphenadrine Citrate, Aspirin, Caffeine)

Medication interactionsSee all drug-to-drug interactions for this medication.
card icon

Orphenadrine Citrate Aspirin Caffeine - Orphenadrine Citrate, Aspirin, Caffeine tablet prescribing information

Indications & Usage

INDICATIONS:

  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.

Dosage & Administration

DOSAGE AND ADMINISTRATION:

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

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

Contraindications

CONTRAINDICATIONS:

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.

Adverse Reactions

ADVERSE REACTIONS:

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.

How Supplied/Storage & Handling

HOW SUPPLIED:

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. 07/24

MG # 11584

Data SourceWe receive information directly from the FDA and PrescriberPoint is updated as frequently as changes are made available
Interactions Banner
Check medication interactionsReview interactions as part of your prescribing workflow

Orphenadrine Citrate Aspirin Caffeine - Orphenadrine Citrate, Aspirin, Caffeine tablet PubMed™ news

No results.Review your filter criteria.
Show the latest PubMed™ articles for Orphenadrine Citrate Aspirin Caffeine - Orphenadrine Citrate, Aspirin, Caffeine tablet