Label: MIRALAX- polyethylene glycol 3350 powder, for solution

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

Drug Label Information

Updated February 1, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each dose) (Packet Only)

    Polyethylene Glycol 3350, 17 g

  • Purpose

    Osmotic Laxative, powder for Solution

    Unflavored powder grit free

    Each Packet contains one dose, net wt 0.5 oz (17g)

    Mix-In Pax®

    Travel Size

    Relieves occasional constipation / irregularity

    Softens stool

    ONCE-DAILY DOSES

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

    This Unit dose package is not child resistant and is intended for Institutional Use Only. Keep this and all drugs out of the reach of children.

  • Directions (Packet Only)

    •
    do not take more than directed unless advised by your doctor
    •
    adults and children 17 years of age and older:
    •
    stir and dissolve one packet of powder (17 g) in any 4 to 8 ounces of beverage (cold, hot or room temperature) then drink
    •
    ensure that the powder is fully dissolved before drinking
    •
    do not drink if there are any clumps
    •
    use once a day
    •
    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)
    •
    tamper-evident: do not use if foil is open or broken
    •
    Unflavored
    •
    Sugar Free
    •
    Dissolves in any Beverage
  • Inactive ingredients

    none

  • Questions or comments?

    1-800-MiraLAX (1-800-647-2529)

  • SPL UNCLASSIFIED SECTION

    Bayer, the Bayer Cross, Mix-In Pax and MiraLAX are registered trademarks of Bayer.

    Dist. By: Bayer HealthCare LLC

    Whippany, NJ 07981

    NeatPAX is a trademark owned by its respective owner.

    Distributed by:

    Cardinal Health

    Dublin, OH 43017

    L4532222-10124

    L4532222-20124

  • Principal Display Panel

    MiraLAX®

    Polyethylene Glycol 3350,

    Powder for Solution, Osmotic Laxative

    6 Packets

    Bag Label
  • INGREDIENTS AND APPEARANCE
    MIRALAX 
    polyethylene glycol 3350 powder, for solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55154-5035(NDC:11523-7268)
    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:55154-5035-66 in 1 BAG02/23/2009
    117 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02201502/23/2009
    Labeler - Cardinal Health 107, LLC (118546603)
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