Label: MIX-IN LAXATIVE PACKETS- polyethylene glycol 3350 powder, for solution

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated March 25, 2023

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  • Active ingredient (in each dose)

    Polyethylene Glycol 3350, 17 g.

  • 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 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 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 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
    • adults and children 17 years of age and older:
      • use once a day
      • stir and dissolve one packet of powder (17 g) 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 more than 7 days
    • children 16 years of age or under: ask a doctor
  • Other information

    • store at 20° - 25°C (68° - 77°F)
    • tamper-evident: do not use if foil is open or broken
  • Inactive ingredients

    none

  • Questions or comments?

    1-888-287-1915

  • Principal display panel

    NDC 49035-906-03

    equate™

    Compare
    to MiraLAX®
    active
    ingredient*

    Mix-In

    Laxative 
    Packets

    Polyethylene Glycol 3350
    Powder for Solution
    Osmotic Laxative

    • Relieves occasional
      constipation
      (irregularity)
    • Softens stool
    • Dissolves in any
      beverage

    10 PACKETS
    NET WT 0.5 OZ
    (17 g) EACH

    10
    ONCE-DAILY
    DOSES

    TAMPER-EVIDENT: DO NOT USE
    IF FOIL IS OPEN OR BROKEN

    Satisfaction guaranteed - or we'll replace it or give you your money
    back. For questions or comments or to report and undesired reaction
    or side effect, please call 1-888-287-1915

    DISTRIBUTED BY: Walmart Inc., Bentonville, AR 72716

    PRODUCT OF INDIA

    *This product is not manufactured or distributed by Bayer HealthCare LLC,
    owner of the registered trademark MiraLAX®.      50844       REV0222B72603

    equate 44-726

    equate 44-726

  • INGREDIENTS AND APPEARANCE
    MIX-IN LAXATIVE PACKETS 
    polyethylene glycol 3350 powder, for solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-906
    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:49035-906-0310 in 1 CARTON10/28/2019
    117 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20392810/28/2019
    Labeler - Wal-Mart Stores Inc (051957769)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464pack(49035-906)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837pack(49035-906)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305pack(49035-906)
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