Label: POLYETHYLENE GLYCOL 3350 powder, for solution
- NDC Code(s): 55154-8184-5
- Packager: Cardinal Health 107, LLC
- This is a repackaged label.
- Source NDC Code(s): 60687-431
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated January 17, 2024
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 sachet)
- Purpose
- Uses
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Warnings
Allergy alert: Do not use if you are allergic to polyethylene glycol.
Do not use if you have kidney disease, except under the advice and supervision of a doctor
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
- Keep out of the reach of children.
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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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- stir and dissolve one sachet of powder (17 g) in any 4 to 8 ounces of beverage (cold, hot or room temperature)
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- drink the solution.
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- use once a day
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- use no more than 7 days
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- children 16 years of age or under: ask a doctor
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Inactive Ingredients
none
Questions or comments?
1-800-707-4621 or www.americanhealthpackaging.com
© 2019 & Distributed by
American Health Packaging
Columbus, Ohio 43217 USAAll rights reserved.
1037831/1037832
Distributed By:
Cardinal Health
Dublin, OH 43017
L5568654-10124
L5568654-20124
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INGREDIENTS AND APPEARANCE
POLYETHYLENE GLYCOL 3350
polyethylene glycol 3350 powder, for solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55154-8184(NDC:60687-431) 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 TITANIUM DIOXIDE (UNII: 15FIX9V2JP) 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:55154-8184-5 7 in 1 BAG 04/15/2019 1 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 ANDA203928 04/15/2019 Labeler - Cardinal Health 107, LLC (118546603)