WINCO- polyethylene glycol 3350 powder, for solution

Winco by

Drug Labeling and Warnings

Winco by is a Otc medication manufactured, distributed, or labeled by WINCO FOODS. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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®

INGREDIENTS AND APPEARANCE

WINCO 
polyethylene glycol 3350 powder, for solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67091-447
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 (Colorless upon dissolution)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67091-447-08	238 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/21/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA202071	08/21/2023

Labeler - WINCO FOODS (056098817)