Product Label Information

• Information not available.

• Polyethylene Glycol minor side effects: cramps, nausea, bloating, diarrhea, gas formation, increased thirst.
• Major: excessive diarrhea, severe weakness, severe dehydration. Always take with at least 8 ounces of water.
• Contact your physician if constipation persists for more than a week after starting this drug or if rectal bleeding occurs.
• There are no known food, beverage or drug interactions with Polyethylene Glycol.
• However, since a laxative effect may occur, other medications should not be taken at the same time because they may be swept down the intestine before they are dissolved and absorbed.
• Miralax can be used periodically long-term.
• It should only be used for 14 days with a 2-4 week period of abstinence between use. ¹³.
• Side effects indicating need for medical attention: allergic reaction (skin rash).
• Side effects indicating need for medical attention, if they continue or are bothersome: bloating, nausea, abdominal or stomach cramps; anal irritation; vomiting.
• Hypothermia was reported in one patient after ingestion of 5 liters of chilled PEG-electrolyte solution.
• One patient experienced cardiac asystole after a large bowel movement following administration of PEG-electrolyte solution.
• Further studies are required to establish a causal relationship.
• A higher incidence of diarrhea occurred in elderly patients when given the recommended dose of 17 grams.
• Discontinue use if diarrhea occurs. Hives or welts, itching, redness of skin, or rash suggests an allergic reaction ²⁶.

• Safety in children has not been established.
• Safety during pregnancy has not been demonstrated.
• Except under special circumstances, this medication should not be used when the following medical problems exist: Intestinal obstruction, paralytic ileus, perforated bowel, toxic colitis, toxic megacolon, severe ulcerative colitis are present as these conditions may be aggravated; colonic perforation may occur in patients with intestinal obstruction or toxic colitis.
• Risk-benefit should be considered when the following medical conditions exist: aspiration (or predisposition to), impaired gag reflex, regurgitation (or predisposition to), unconscious or semi-conscious state. Additives (sweeteners, flavoring agents) are not recommended...such additives may change the osmolality of the solution; sucrose may cause fluid and electrolyte absorption.
• Additives may also predispose to colonic bacterial fermentation and formation of combustible gases ²⁶.

Data Gathering, Research & Reporting
by Carole Engel, Director Of Outreach
? 2004 Fruit-Eze?, Inc.