Label: POLYETHYLENE GLYCOL 3350 powder, for solution
- NDC Code(s): 51991-961-58, 51991-962-57
- Packager: Breeckenridge Pharmaceutical, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated October 4, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each dose)
- Purpose
- Use
-
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
-
Directions
- do not take more than directed unless advised by your doctor
- this product is supplied with a dosing cup marked to contain 17 grams of powder when filled to the indicated line
- adults and children 17 years of age and older:
- use once a day
- fill to the indicated "17 GRAMS" line on cup 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?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 238 g Bottle Label
- PRINCIPAL DISPLAY PANEL - 510 g Bottle Label
-
INGREDIENTS AND APPEARANCE
POLYETHYLENE GLYCOL 3350
polyethylene glycol 3350 powder, for solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51991-961 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:51991-961-58 238 g in 1 BOTTLE; Type 0: Not a Combination Product 03/27/2019 09/30/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA090812 03/27/2019 09/30/2024 POLYETHYLENE GLYCOL 3350
polyethylene glycol 3350 powder, for solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51991-962 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:51991-962-57 510 g in 1 BOTTLE; Type 0: Not a Combination Product 03/27/2019 07/31/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA090812 03/27/2019 09/30/2024 Labeler - Breeckenridge Pharmaceutical, Inc. (150554335) Establishment Name Address ID/FEI Business Operations LGM Pharma Solutions, LLC 117549200 MANUFACTURE(51991-961, 51991-962)