Label: POLYETHYLENE GLYCOL 3350 powder, for solution
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Contains inactivated NDC Code(s)
NDC Code(s): 10135-683-04, 10135-683-08, 10135-683-12 - Packager: Marlex Pharmaceuticals Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated May 21, 2019
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- SPL UNCLASSIFIED SECTION
- 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
- nausea, vomiting or abdominal pain
- a sudden change in bowel habits that lasts over 2 weeks
- irritable bowel syndrome
- nausea, vomiting or abdominal pain
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Directions
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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 (clear section in cap)
- adults and children 17 years of age and older:
○ fill to top of clear 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
○ use once a day
○ use no more than 7 days
- children 16 years of age or under: ask a doctor
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do not take more than directed unless advised by your doctor
- Other information
- Inactive ingredient
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
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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:10135-683 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:10135-683-04 119 g in 1 BOTTLE; Type 0: Not a Combination Product 04/01/2019 2 NDC:10135-683-08 238 g in 1 BOTTLE; Type 0: Not a Combination Product 04/01/2019 3 NDC:10135-683-12 510 g in 1 BOTTLE; Type 0: Not a Combination Product 04/01/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA202071 04/01/2019 Labeler - Marlex Pharmaceuticals Inc (782540215)