Label: POLYETHYLENE GLYCOL 3350 powder, for solution

  • NDC Code(s): 53943-742-49, 53943-742-90
  • Packager: Discount Drug Mart
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated March 19, 2022

If you are a consumer or patient please visit this version.

  • Active ingredient (in each dose)

    Polyethylene Glycol 3350,
    17 grams (cap filled to the indicated “17 GRAMS” line)

  • Purpose

    Laxative

  • Uses

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

    If pregnant or breast-feeding,

    ask a health professional before use.

    Keep out of 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 cap is a measuring cup marked to contain 17 grams of powder when filled to the indicated “17 GRAMS” line
    • adults and children 17 years of age and older:
      • fill to indicated “17 GRAMS” line in cap which is marked to indicate the correct dose 17 grams
      • stir and dissolve in any 4 to 8 ounces of beverage (cold, hot or room temperature) then drink
      • use once a day
      • use no more than 7 days
    • children 16 years of age or younger: ask a doctor
  • Other information

    • store at 20°-25°C (68°-77°F)
    • tamper-evident: do not use if foil seal under cap printed with “SEALED for YOUR PROTECTION” is missing, open or broken.
  • Inactive ingredients

    none

  • Questions or comments?

    1-800-426-9391

  • Principal display panel

    Discount 
    Drug
    Mart
    Food Fair

    NDC 53943-742-90

    ORIGINAL PRESCRIPTION STRENGTH

    Polyethylene
    Glycol 3350

    Powder For Solution     Osmotic Laxative

    Relieves occasional constipation (irregularity)
    and softens stool

    • Sugar Free

    • Dissolves in
      any beverage

    *Compare to the active ingredient in MiraLAX®

    UNFLAVORED POWDER

    NET WT 17.9 OZ (510 g)  30 ONCE-DAILY DOSES

    SATISFACTION GUARANTEED IF DISSATISFIED, RETURN UNUSED PORTION AND PACKAGE
    TO STORE WHERE PURCHASED. IF UNABLE TO RETURN TO STORE, SEND REASON FOR
    DISSATISFACTION, NAME, ADDRESS AND EMPTY PACKAGE TO: DISCOUNT DRUG MART
    211 COMMERCE DRIVE, MEDINA, OHIO 44256

    DISTRIBUTED BY: DRUG MART - FOOD FAIR
    211 COMMERCE DRIVE
    MEDINA, OH 44256
    www.discount-drugmart.com

    Polyethylene Glycol 3350 increases the frequency
    of bowel movements and softens the stool

    TAMPER-EVIDENT: DO NOT USE IF PRINTED FOIL SEAL UNDER CAP IS MISSING, OPEN OR BROKEN

    *This product is not manufactured or distributed by Bayer HealthCare LLC, owner of the registered trademark MiraLAX®.

    50844 REV0719A74290

    7116-0510-Q8-BL
    Rev 06/21

    Drug Mart 44-742

    Drug Mart 44-742

  • INGREDIENTS AND APPEARANCE
    POLYETHYLENE GLYCOL 3350 
    polyethylene glycol 3350 powder, for solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53943-742
    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
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53943-742-90510 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/21/2019
    2NDC:53943-742-49238 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/21/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09081208/21/2019
    Labeler - Discount Drug Mart (047741335)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837pack(53943-742)