Polyethylene Glycol 3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Ascorbic Acid, Sodium Ascorbate

1 INDICATIONS AND USAGE MoviPrep® is an osmotic laxative indicated for cleansing of the colon as a preparation for colonoscopy in adults. MoviPrep is an osmotic laxative indicated for cleansing of the colon as a preparation for colonoscopy in adults. ( 1 )

6 ADVERSE REACTIONS The following serious or otherwise important adverse reactions for bowel preparations are described elsewhere in the labeling: • Serious Fluid and Electrolyte Abnormalities [see Warnings and Precautions (5.1) ] • Cardiac Arrhythmias [see Warnings and Precautions (5.2) ] • Seizures [see Warnings and Precautions (5.3)] • Patients with Renal Impairment [see Warnings and Precautions (5.4)] • Colonic Mucosal Ulceration, Ischemic Colitis and Ulcerative Colitis [see Warnings and Precautions (5.5)] • Patients with Significant Gastrointestinal Disease [see Warnings and Precautions (5.6)] • Aspiration [see Warnings and Precautions (5.7)] • Glucose-6-Phosphate Dehydrogenase (G6PD) Deficiency [see Warnings and Precautions (5.8)] • Risks in Patients with Phenylketonuria [see Warning...

8.1 Pregnancy Risk Summary There are no available data on MoviPrep in pregnant women to inform a drug-associated risk for adverse developmental outcomes. Animal reproduction studies have not been conducted with MoviPrep. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

5 WARNINGS AND PRECAUTIONS • Risk of fluid and electrolyte abnormalities: Encourage adequate hydration, assess concurrent medications, and consider laboratory assessments prior to and after use. ( 5.1 , 7.1 ) • Cardiac arrhythmias: Consider pre-dose and post-colonoscopy ECGs in patients at increased risk. ( 5.2 ) • Seizures : Use caution in patients with a history of seizures and patients at increased risk of seizure, including medications that lower the seizure threshold. ( 5.3 , 7.1 ) • Patients with renal impairment or taking concomitant medications that affect renal function: Use caution, ensure adequate hydration and consider laboratory testing. 4 CONTRAINDICATIONS MoviPrep is contraindicated in the following conditions: • Gastrointestinal (GI) obstruction [see Warnings and Precautions (5.6) ] • Bowel perforation [see Warnings and Precautions (5.6) ] • Gastric retention • Ileus • Toxic colitis or toxic megacolon • Hypersensitivity to any ingredient in MoviPrep [see Warnings and Precautions (5.10) and Description (11) ] • Gastrointestinal...