Winco

Label at a glance#

Contacts and useful links#

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each dose)

OTC - ACTIVE INGREDIENT SECTION

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

Purpose

OTC - PURPOSE SECTION

Osmotic Laxative

Use

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Allergy alert

SPL UNCLASSIFIED SECTION

Do not use if you are allergic to polyethylene glycol

OTC - DO NOT USE SECTION

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

OTC - ASK DOCTOR SECTION

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

OTC - ASK DOCTOR/PHARMACIST SECTION

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

OTC - WHEN USING SECTION

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

Stop use and ask a doctor if

OTC - STOP USE SECTION

• 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

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

• 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

STORAGE AND HANDLING SECTION

• store at 20°-25°C (68°-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

none

Questions or comments?

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.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®

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Products#

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• Winco
• Polyethylene Glycol 3350

NDC Codes#

Ingredients#

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Observed Orange Book product history#

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Product history page 1 of 2 · 43 observed states.

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Reported adverse events (FAERS/openFDA)#

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