Label: WINCO- polyethylene glycol 3350 powder, for solution
- NDC Code(s): 67091-447-08
- Packager: WINCO FOODS
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated December 6, 2023
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- SPL UNCLASSIFIED SECTION
- Active ingredient (in each dose)
- Purpose
- Use
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Warnings
Ask a doctor before use if you have
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- nausea, vomiting or abdominal pain
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- a sudden change in bowel habits that lasts over 2 weeks
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- irritable bowel syndrome
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Directions
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- do not take more than directed unless advised by your doctor
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- the bottle top is a measuring cap marked to contain 17 grams of powder when filled to the indicated line (white section in cap)
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adults and children 17 years of age and older:
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- use once a day
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- fill to top of white section in cap which is marked to indicate the correct dose (17 g)
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- stir and dissolve in any 4 to 8 ounces of beverage (cold, hot or room temperature) then drink
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- do not combine with starch-based thickeners used for difficulty swallowing
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- ensure that the powder is fully dissolved before drinking
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- do not drink if there are any clumps
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- do not use no more than 7 days
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- children 16 years of age or under: ask a doctor
- Other information
- Inactive ingredients
- Questions or comments?
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PRINCIPAL DISPLAY PANEL
*Compare to the active ingredient in MiraLAX®
NDC 67091-447-08
Polyethylene Glycol 3350,
Powder for Solution,
Osmotic Laxative
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- Relieves Occasional Constipation/Irregularity
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- Softens Stool
UNFLAVORED POWDER
14 ONCE-DAILY DOSESNET WT 8.3 OZ (238 g)
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- Dissolves in Any Beverage
DISTRIBUTED BY: WINCO FOODS, LLC
BOISE, ID, 83704
*This product is not manufactured or distributed by Bayer HealthCare LLC, the distributer of MiraLAX®
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INGREDIENTS AND APPEARANCE
WINCO
polyethylene glycol 3350 powder, for solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67091-447 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:67091-447-08 238 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/21/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA022015 08/21/2023 Labeler - WINCO FOODS (056098817)