Label: MIRALAX- polyethylene glycol 3350 powder, for solution
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NDC Code(s):
76420-489-10,
76420-489-20,
76420-489-24,
76420-489-77, view more76420-489-85
- Packager: ASCLEMED USA INC.
- This is a repackaged label.
- Source NDC Code(s): 11523-7268
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated October 14, 2025
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each dose) (Bottle Only)
- Purpose
- Active ingredient (in each dose) (Packet Only)
- Purpose
- Use
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Warnings
Ask a doctor before use if you have
- nausea, vomiting or abdominal pain
- a sudden change in bowel habits that lasts over 2 weeks
- irritable bowel syndrome
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Directions (Bottle Only)
- do not take more than directed unless advised by your doctor
- the bottle top is a measuring cap marked to contain 17 grams of powder when filled to the indicated line (white section in cap)
- adults and children 17 years of age and older:
- use once a day
- fill to top of white section in cap which is marked to indicate the correct dose (17 g)
- stir and dissolve in any 4 to 8 ounces of beverage (cold, hot or room temperature) then drink
- do not combine with starch-based thickeners used for difficulty swallowing
- ensure that the powder is fully dissolved before drinking
- do not drink if there are any clumps
- do not use no more than 7 days
- children 16 years of age or under: ask a doctor
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Directions (Packet Only)
- do not take more than directed unless advised by your doctor
- adults and children 17 years of age and older:
- use once a day
- stir and dissolve one packet of powder (17 g) in any 4 to 8 ounces of beverage (cold, hot or room temperature) then drink
- do not combine with starch-based thickeners used for difficulty swallowing
- ensure that the powder is fully dissolved before drinking
- do not drink if there are any clumps
- do not use more than 7 days
- children 16 years of age or under: ask a doctor
- Other information
- Inactive ingredients
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
MIRALAX
polyethylene glycol 3350 powder, for solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76420-489(NDC:11523-7268) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P) (POLYETHYLENE GLYCOL 3350 - UNII:G2M7P15E5P) POLYETHYLENE GLYCOL 3350 17 g in 17 g Product Characteristics Color white (Colorless upon dissolution) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76420-489-10 10 in 1 CARTON 10/14/2025 1 17 g in 1 PACKET; Type 0: Not a Combination Product 2 NDC:76420-489-24 24 in 1 CARTON 10/14/2025 2 17 g in 1 PACKET; Type 0: Not a Combination Product 3 NDC:76420-489-77 765 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/14/2025 4 NDC:76420-489-20 20 in 1 CARTON 10/14/2025 4 17 g in 1 POUCH; Type 0: Not a Combination Product 5 NDC:76420-489-85 850 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/14/2025 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA022015 02/01/2007 Labeler - ASCLEMED USA INC. (059888437) Establishment Name Address ID/FEI Business Operations ASCLEMED USA INC. DBA ENOVACHEM 059888437 relabel(76420-489)
