WINCO- polyethylene glycol 3350 powder, for solution 
WINCO FOODS

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Winco Polyethylene Glycol 3350 Drug fact

Drug Facts

Active ingredient (in each dose)

Polyethylene Glycol 3350, 17 g (cap filled to line)

Purpose

Osmotic Laxative

Use

▪
relieves occasional constipation /irregularity
▪
generally produces a bowel movement in 1 to 3 days

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

▪
nausea, vomiting or abdominal pain
▪
a sudden change in bowel habits that lasts over 2 weeks
▪
irritable bowel syndrome

Ask a doctor of pharmacist before use if you are taking a prescription drug

When using this productyou may have loose, watery, more frequent stools

Stop use and ask a doctor if

•
you have rectal bleeding or your nausea, bloating or cramping or abdominal pain gets worse. These may be signs of a serious condition.
•
you get diarrhea
•
you need to use a laxative for longer than 1 week

If pregnant or breast-feeding, ask a health professional before use.

Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

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 top of white 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
▪
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 no more than 7 days
▪
children 16 years of age or under: ask a doctor

Other information

•
store at 20°-25°C (68°-77°F)

Inactive ingredients

none

Questions or comments?

1-866-467-2748

TAMPER-EVIDENT: DO NOT USE IF FOIL SEAL UNDER CAP, PRINTED WITH "SEALED FOR YOUR PROTECTION" IS MISSING, OPEN OR BROKEN

PRINCIPAL DISPLAY PANEL

*Compare to the active ingredient in MiraLAX®

NDC 67091-447-08

Polyethylene Glycol 3350,

Powder for Solution,

Osmotic Laxative

•
Relieves Occasional Constipation/Irregularity
•
Softens Stool

UNFLAVORED POWDER
14 ONCE-DAILY DOSES

NET WT 8.3 OZ (238 g)

•
Dissolves in Any Beverage

DISTRIBUTED BY: WINCO FOODS, LLC

BOISE, ID, 83704

*This product is not manufactured or distributed by Bayer HealthCare LLC, the distributer of MiraLAX®

WINCO Polyethelene Glycol3350 14 Once daily Doses
WINCO 
polyethylene glycol 3350 powder, for solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67091-447
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P) (POLYETHYLENE GLYCOL 3350 - UNII:G2M7P15E5P) POLYETHYLENE GLYCOL 335017 g  in 17 g
Product Characteristics
Colorwhite (Colorless upon dissolution) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67091-447-08238 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/21/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02201508/21/2023
Labeler - WINCO FOODS (056098817)

Revised: 9/2023
Document Id: d649f758-a46f-4864-8718-878ee5a74bfc
Set id: d649f758-a46f-4864-8718-878ee5a74bfc
Version: 1
Effective Time: 20230907
 
WINCO FOODS