Label: BENZTROPINE MESYLATE tablet

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated April 22, 2025

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  • SPL UNCLASSIFIED SECTION
    Rx only
  • DESCRIPTION
    Benztropine mesylate is a synthetic compound containing structural features found in atropine and diphenhydramine. It is a crystalline white powder, very soluble in water, designated as ...
  • CLINICAL PHARMACOLOGY
    Benztropine mesylate possesses both anticholinergic and antihistaminic effects, although only the former have been established as therapeutically significant in the management of parkinsonism. In ...
  • INDICATIONS AND USAGE
    For use as an adjunct in the therapy of all forms of parkinsonism. Useful also in the control of extrapyramidal disorders (except tardive dyskinesia – see - PRECAUTIONS) due to ...
  • CONTRAINDICATIONS
    Hypersensitivity to benztropine mesylate tablets. Because of its atropine-like side effects, this drug is contraindicated in pediatric patients under three years of age, and should be used with ...
  • WARNINGS
    Safe use in pregnancy has not been established. Benztropine mesylate may impair mental and/or physical abilities required for performance of hazardous tasks, such as operating machinery or driving ...
  • PRECAUTIONS
    General - Since benztropine mesylate has cumulative action, continued supervision is advisable. Patients with a tendency to tachycardia and patients with prostatic hypertrophy should be observed ...
  • ADVERSE REACTIONS
    The adverse reactions below, most of which are anticholinergic in nature, have been reported and within each category are listed in order of decreasing severity. Cardiovascular Tachycardia ...
  • OVERDOSAGE
    Manifestations - May be any of those seen in atropine poisoning or antihistamine overdosage; CNS depression, preceded or followed by stimulation; confusion; nervousness; listlessness ...
  • DOSAGE AND ADMINISTRATION
    Benztropine mesylate tablets should be used when patients are able to take oral medication. Because of cumulative action, therapy should be initiated with a low dose which is increased gradually ...
  • HOW SUPPLIED
    Benztropine Mesylate Tablets, USP are available as follows: 1 mg: white, oval, scored tablets, debossed "2326" on one side and debossed "V" on the reverse side, supplied in - NDC: 70518-0132-00 - NDC ...
  • SPL UNCLASSIFIED SECTION
    Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762
  • PRINCIPAL DISPLAY PANEL
    DRUG: Benztropine Mesylate - GENERIC: benztropine mesylate - DOSAGE: TABLET - ADMINSTRATION: ORAL - NDC: 70518-0132-0 - NDC: 70518-0132-1 - COLOR: white - SHAPE: OVAL - SCORE: Two even pieces - SIZE: 10 mm - IMPRINT ...
  • INGREDIENTS AND APPEARANCE
    Product Information