Label: SKY PEG3350- polyethylene glycol 3350 powder, for solution
- NDC Code(s): 63739-198-61, 63739-198-62
- Packager: McKesson Corporation dba SKY Packaging
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated April 14, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each dose)
- Purpose
- Use
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Warnings
Allergy alert: Do not use if you are allergic to polyethylene glycol
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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- adults and children 17 years of age and older:
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- use once a day
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- stir and dissolve one packet of powder (17 g) 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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- 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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Compare to MiraLAX® active ingredient
PEG3350
Polyethylene Glycol 3350 Powder for Solution, Osmotic Laxative
- Relieves Occasional Constipation (Irregularity) –
- Softens Stool -
Unflavored Powder ● Grit Free
Unflavored Powder Dissolves In Any Beverage!
30 Once-Daily Doses
30 Packets – NET WT 0.5 OZ (17g) Each
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INGREDIENTS AND APPEARANCE
SKY PEG3350
polyethylene glycol 3350 powder, for solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63739-198 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 Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63739-198-61 30 in 1 CARTON 06/08/2020 1 NDC:63739-198-62 17 g in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA090685 06/08/2020 Labeler - McKesson Corporation dba SKY Packaging (140529962)