What is the age limit for administering Miralax (polyethylene glycol)?

Age Limit for Miralax (Polyethylene Glycol)

Miralax (polyethylene glycol 3350) should not be used in children 16 years of age or under without physician guidance, as clearly stated on the FDA-approved drug label. 1

Age Restrictions for Miralax

• The FDA-approved labeling for Miralax (polyethylene glycol 3350) specifically states that it is approved for "adults and children 17 years of age and older" 1
• For "children 16 years of age or under," the label explicitly directs to "ask a doctor" before use 1
• This age restriction applies to both the bottled powder and individual packet formulations of Miralax 1

Dosing Recommendations

Approved Use (17 years and older):

• Adults and children 17 years and older: Use once daily 1
• Standard dose is one 17g packet or capful dissolved in 4-8 ounces of beverage 1
• Treatment duration should not exceed 7 days without medical supervision 1

Children Under 17 Years:

• Requires physician guidance and supervision 1
• No FDA-approved dosing guidelines exist for this age group 1
• Off-label use in pediatric patients should be determined by a healthcare provider based on individual patient needs 2

Safety Considerations

• Polyethylene glycol 3350 is generally considered safe when used appropriately 3
• Common side effects in approved populations include mild gastrointestinal symptoms such as diarrhea, loose stools, flatulence, and nausea 3
• The age restriction is important as children may have different physiological responses to medications compared to adults 4
• Children under 2 years of age have significant differences in drug metabolism and excretion that require special consideration 4

Clinical Context

• While Miralax has been studied for pediatric constipation and is sometimes prescribed off-label by physicians, the FDA-approved labeling maintains the age restriction 2
• For pediatric constipation, physicians may prescribe Miralax after proper evaluation, but this should be done under medical supervision with appropriate dosing adjustments 2
• The safety profile for long-term use (up to 12 months) has been established in adults but not formally in pediatric populations 3

Important Precautions

• Ensure the powder is fully dissolved before drinking 1
• Do not combine with starch-based thickeners used for difficult swallowing 1
• Do not use if there are any undissolved clumps in the solution 1
• For any use in children under 17 years, medical consultation is required 1