Label: WALGREENS- polyethylene glycol 3350 powder, for solution

  • NDC Code(s): 0363-5260-07, 0363-5260-14
  • Packager: WALGREEN COMPANY
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated March 8, 2024

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  • 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 product you 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 at 1-800-222-1222.

  • 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:
    o
    use once a day
    o
    fill to top of white section in cap which is marked to indicate the correct dose (17 g)
    o
    stir and dissolve in any 4 to 8 ounces of beverage (cold, hot or room temperature) then drink
    o
    do not combine with starch-based thickeners used for difficulty swallowing
    o
    ensure that the powder is fully dissolved before drinking
    o
    do not drink if there are any clumps
    o
    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 0363-5260-07

    Polyethylene Glycol 3350,

    Powder for Solution,

    Osmotic Laxative

    •
    Relieves Occasional Constipation/Irregularity
    •
    Softens Stool

    UNFLAVORED POWDER
    7 ONCE-DAILY DOSES

    NET WT 4.1 OZ (119 g)

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

    Walgreen Polyethylene Glycol3350 7 ONCE Daily Dose
  • Principal Display Panel

    *Compare to the Active Ingredient in MiraLAX®

    NDC 0363-5260-14

    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)

    Walgreens Polyethylene Glycol3350 14 Once Daily Doses
  • INGREDIENTS AND APPEARANCE
    WALGREENS 
    polyethylene glycol 3350 powder, for solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-5260
    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:0363-5260-07119 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/01/2023
    2NDC:0363-5260-14238 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/01/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20207103/01/2023
    Labeler - WALGREEN COMPANY (008965063)
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