Label: POLYETHYLENE GLYCOL 3350, NF POWDER FOR SOLUTION, LAXATIVE powder, for solution
- NDC Code(s): 79739-7116-1, 79739-7116-2, 79739-7116-3
- Packager: LGM PHARMA SOLUTIONS, LLC
- 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)
- SPL UNCLASSIFIED SECTION
- Active Ingredient (in each dose)
- Purpose
- Use
-
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
Manufactured by:
LGM Pharma Solutions, LLC
Irvine, CA 92614
7116-0119-99-EC-PD
Rev. 01/2022
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
-
Directions
-
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 (white section in cap)
- adults and children 17 years of age and older:
- use once a day
- fill to the top of white section in cap which is marked to indicate the correct dose (17g)
- 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
- use once a day
- children 16 years of age or under: ask a doctor
-
do not take more than directed unless advised by your doctor
- Other Information
- Inactive ingredients
- Questions or comments?
- Principal Display Panel
- Principal Display Panel
- Principal Display Panel
-
INGREDIENTS AND APPEARANCE
POLYETHYLENE GLYCOL 3350, NF POWDER FOR SOLUTION, LAXATIVE
polyethylene glycol 3350, nf powder for solution, laxative powder, for solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79739-7116 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 1 d 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:79739-7116-1 7 d in 1 BOTTLE; Type 0: Not a Combination Product 10/07/2009 2 NDC:79739-7116-2 14 d in 1 BOTTLE; Type 0: Not a Combination Product 10/07/2009 3 NDC:79739-7116-3 30 d in 1 BOTTLE; Type 0: Not a Combination Product 10/07/2009 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA090812 10/07/2009 Labeler - LGM PHARMA SOLUTIONS, LLC (117549198) Establishment Name Address ID/FEI Business Operations LGM Pharma Solutions, LLC 117549200 analysis(79739-7116) , label(79739-7116) , manufacture(79739-7116) , pack(79739-7116)
