Label: DISCOUNT DRUG MART- polyethylene glycol 3350 powder, for solution

  • NDC Code(s): 53943-652-14, 53943-652-30
  • Packager: DISCOUNT DRUG MART
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated August 31, 2023

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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.

  • 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

    DISCOUNT DRUG MART

    NDC 53943-652-14

    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)

    •
    Dissolves in ANY Beverage

    DISTRIBUTED BY: DRUG MART-FOOD FAIR

    MEDINA, OHIO 44256

    www.discount-drugmart.com

    SATISFACTION GUARANTEED

    IF DISSATISFIED, RETURN UNUSED PORTION AND PACKAGE TO THE STORE WHERE PURCHASED. IF UNABLE TO RETURN TO STORE, SEND REASON FOR DISSATIFACTION, NAME, ADRESS AND PACKAGE TO:

    DISCOUNT DRUG MART, 211 COMMERCE DRIVE, MEDINA, OHIO 044256

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

    DDM Polyethylene Glycol3350 14 Once Daily Doses
  • Principal Display Panel

    DISCOUNT DRUG MART

    NDC 53943-652-30

    Polyethylene Glycol 3350,

    Powder for Solution,

    Osmotic Laxative

    •
    Relieves Occasional Constipation/Irregularity
    •
    Softens Stool

    UNFLAVORED POWDER
    30 ONCE-DAILY DOSES

    NET WT 17.9 OZ (510g)

    DDM Polyethylene Glycol3350 30 Once Daily Doses
  • INGREDIENTS AND APPEARANCE
    DISCOUNT DRUG MART 
    polyethylene glycol 3350 powder, for solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53943-652
    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:53943-652-30510 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/17/2023
    2NDC:53943-652-14238 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/17/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02201504/17/2023
    Labeler - DISCOUNT DRUG MART (047741335)
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