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  5. Label Information: Glycopyrrolate

FDA Label for Glycopyrrolate

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    1. DESCRIPTION

Glycopyrrolate Product Label

The following document was submitted to the FDA by the labeler of this product Par Formulations Private Limited. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Description



Glycopyrrolate tablets contain the synthetic anticholinergic glycopyrrolate. Glycopyrrolate is a quaternary ammonium compound with the following chemical name: 3-[(cyclopentylhydroxyphenylacetyl)oxy]-1,1-

dimethylpyrrolidinium bromide. Its empirical formula is C19H28BrNO3, its molecular weight is 398.33, and its structural formula is:


glycopyrrolate - chemicalstructure

glycopyrrolate - chemicalstructure


Each 1 mg tablet contains: Glycopyrrolate, USP ................1 mg

Each 2 mg tablet contains: Glycopyrrolate, USP ................2 mg


Inactive Ingredients: Dibasic Calcium Phosphate, Lactose, Magnesium Stearate, Povidone, Sodium Starch Glycolate.


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