Label: MIRALAX ORANGE FLAVOR- polyethylene glycol 3350 powder, for solution
- NDC Code(s): 11523-0122-1, 11523-0122-2
- Packager: Bayer HealthCare LLC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated December 6, 2024
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each dose)
- 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 more than 7 days
- children 16 years of age or under: ask a doctor
- Other information
- Inactive ingredients
- Questions or comments?
- PRINCIPAL DISPLAY PANEL - 7 Dose Bottle
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INGREDIENTS AND APPEARANCE
MIRALAX ORANGE FLAVOR
polyethylene glycol 3350 powder, for solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11523-0122 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 Inactive Ingredients Ingredient Name Strength SUCRALOSE (UNII: 96K6UQ3ZD4) Product Characteristics Color white (White or almost white solid with a waxy or paraffin-like appearance) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11523-0122-2 119 g in 1 BOTTLE; Type 0: Not a Combination Product 09/15/2023 2 NDC:11523-0122-1 238 g in 1 BOTTLE; Type 0: Not a Combination Product 09/15/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA090685 09/15/2023 Labeler - Bayer HealthCare LLC. (112117283)