At what age is Miralax (polyethylene glycol) safe to give to children?

Safe Age for Administering Miralax (Polyethylene Glycol)

According to the FDA drug label, Miralax (polyethylene glycol 3350) is only approved for use in adults and children 17 years of age and older. 1 For children 16 years of age or under, the label specifically states to "ask a doctor" before use.

Age-Based Recommendations

Children 17 years and older:

• Can use adult dosing (17g once daily)
• Dissolve in 4-8 ounces of beverage
• Should not use for more than 7 days without medical supervision

Children 16 years and under:

• Requires physician guidance and supervision
• Not FDA-approved for routine use
• Physician must make case-by-case determination based on clinical need

Off-Label Use in Pediatric Populations

Despite the FDA labeling restrictions, polyethylene glycol 3350 is commonly used off-label in pediatric populations under physician supervision for constipation management. When prescribed by physicians:

• Safety studies have shown that short-term use for bowel preparation before colonoscopy is generally well-tolerated in children as young as 2 years 2
• For chronic constipation, many pediatric gastroenterologists prescribe it off-label with careful dosing adjustments

Important Considerations for Pediatric Use

When physicians consider prescribing Miralax to children under 17:

1. Dosing must be adjusted based on the child's weight and age
2. Duration should be limited and monitored by healthcare providers
3. Electrolyte monitoring may be necessary with prolonged use
4. Alternative treatments should be considered first, including:
   • Dietary modifications (increased fiber and fluids)
   • Regular toilet habits
   • Other age-appropriate laxatives

Common Pitfalls to Avoid

• Self-medicating children without medical supervision: The FDA label explicitly requires physician guidance for anyone under 17
• Prolonged use without medical follow-up: Even in adults, use beyond 7 days requires medical supervision
• Improper mixing: Ensure powder is fully dissolved before administration
• Using with starch-based thickeners: This combination should be avoided

Conclusion

While Miralax is only FDA-approved for adults and children 17 years and older, physicians may prescribe it off-label for younger children on a case-by-case basis. Parents should never administer Miralax to children under 17 without specific physician guidance and supervision.