Label: POLYETHYLENE GLYCOL- 3350 powder, for solution
- NDC Code(s): 51079-306-01, 51079-306-30
- Packager: Mylan Institutional Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Updated August 14, 2019
If you are a consumer or patient please visit this version.
- Active ingredient (in each dose)
- Do not use
- Ask a doctor before use if you have
- Ask a doctor or pharmacist before use if you are
- When using this product
- Stop use and ask a doctor if
- If pregnant or breast-feeding,
- Keep out of reach of children.
- do not take more than directed unless advised by your doctor
- adults and children 17 years of age and older:
- stir and dissolve the contents of one pouch (17 g) in any 4 to 8 ounces of beverage (cold, hot or room temperature) then drink
- ensure that the powder is fully dissolved before drinking
- do no drink if there are any clumps
- use once a day
- use no more than 7 days
- children 16 years of age or under: ask a doctor
- Other Information
- Inactive ingredients
- Questions or comments?
Principal Display Panel
Polyethylene Glycol 3350, USP
Powder for Solution,
- Relieves Occasional Constipation/Irregularity
- Softens Stool
- Grit Free
- Sugar Free
- Dissolves in Any Beverage
This carton contains 30 single-dose pouches.
Each pouch contains 17 grams of
polyethylene glycol 3350, USP powder.
For institutional use only. 30 Single-Dose Pouches
INGREDIENTS AND APPEARANCE
POLYETHYLENE GLYCOL (3350)
polyethylene glycol (3350) powder, for solution
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51079-306 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POLYETHYLENE GLYCOL 3500 (UNII: FVS1AZD90Y) (POLYETHYLENE GLYCOL 3500 - UNII:FVS1AZD90Y) POLYETHYLENE GLYCOL 3500 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:51079-306-30 30 in 1 CARTON 10/12/2009 1 NDC:51079-306-01 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 ANDA078915 10/12/2009 Labeler - Mylan Institutional Inc. (039615992)