No additional ingredients (e.g., flavorings) should be added to the solution. COLYTE^® and COLYTE^®-FLAVORED should be used with caution in patients with severe ulcerative colitis.

General

Patients with impaired gag reflex, unconscious or semiconscious patients and patients prone to regurgitation or aspiration should be observed during the administration of COLYTE^® or COLYTE^®-FLAVORED, especially if it is administered via nasogastric tube. If gastrointestinal obstruction or perforation is suspected, appropriate studies should be performed to rule out these conditions before administration of COLYTE^® or COLYTE^®-FLAVORED.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Studies to evaluate carcinogenic or mutagenic potential or potential to adversely affect male or female fertility have not been performed.

Pregnancy

Category C. Animal reproduction studies have not been conducted with COLYTE^® (PEG-3350 & ELECTROLYTES For Oral Solution) or COLYTE^®-FLAVORED, and it is not known whether COLYTE^® or COLYTE^®-FLAVORED can affect reproductive capacity or harm the fetus when administered to a pregnant patient. COLYTE^® or COLYTE^®-FLAVORED should be given to a pregnant patient only if clearly needed.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

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