1 INDICATIONS AND USAGE Glycopyrrolate Tablets, USP are indicated in adults to reduce symptoms of a peptic ulcer as an adjunct to treatment of peptic ulcer.

Limitations of Use Glycopyrrolate Tablets, USP are not indicated as monotherapy for the treatment of peptic ulcer because effectiveness in peptic ulcer healing has not been established.

Glycopyrrolate tablets, USP are anticholinergics indicated in adults to reduce symptoms of a peptic ulcer as an adjunct to treatment of peptic ulcer.

(1) Limitations of Use: Not indicated as monotherapy for the treatment of peptic ulcer because effectiveness in peptic ulcer healing has not been established.

(1)

6 ADVERSE REACTIONS The following serious or otherwise important adverse reactions are discussed elsewhere in the labeling: Precipitation of Acute Glaucoma [see Warnings and Precautions (5.1) ] Partial or Complete Mechanical Intestinal Obstruction [see Warnings and Precautions (5.2) ] Gastrointestinal Adverse Reactions due to Decreased Gastrointestinal Motility [see Warnings and Precautions (5.3) ] Cognitive and Visual Adverse Reactions [see Warnings and Precautions (5.4) ] Heat Prostration at High Environmental Temperatures [see Warnings and Precautions (5.5) ] Other Conditions Exacerbated by Anticholinergic Adverse Reactions [see Warnings and Precautions (5.6) ] Increased Risk of Anticholinergic Adverse Reactions in Geriatric Patients [see Warnings and Precautions (5.7) ] The following adverse reactions associated with the use of glycopyrrolate, or other anticholinergic drugs, were identified in clinical studies or post marketing reports.

Because some of these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Cardiac Disorders: chest, pain, hypertension, tachycardia Endocrine Disorders: decreased sweating Eye Disorders: blurred vision, cycloplegia, dilatation of the pupil, increased ocular tension Gastrointestinal Disorders: bloated feeling, constipation, dry mouth, dysgeusia, nausea, vomiting Immune System Disorders : anaphylaxis [see Contraindications (4) ] Nervous System Disorders : agitation, dizziness, drowsiness, headache, insomnia, mental confusion, nervousness, weakness Respiratory Disorders: respiratory depression, throat irritation Renal and Urinary Disorders: urinary hesitancy, urinary retention Reproductive System and Breast Disorders: impotence, suppression of lactation Vascular Disorders: flushing Adverse reactions include blurred vision, drowsiness, decreased sweating, flushing, vomiting, constipation, dry mouth, tachycardia, and urinary retention.

(6) To report SUSPECTED ADVERSE REACTIONS, contact Leading Pharma, LLC at 1-844-740-7500 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.