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 28, 2025

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

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

    Polyethylene Glycol 3350, 17 g (cap filled to line)

  • Purpose

    Osmotic Laxative

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

    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 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 you 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 (Bottle Only)

    •
    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
  • Directions (Packet Only)

    •
    do not take more than directed unless advised by your doctor
    •
    adults and children 17 years of age and older:
    o
    use once a day
    o
    stir and dissolve one packet of powder (17 g) 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 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?

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

    WARNING: 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.

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

    ©2021 Bayer.

    Pat.: patents.livewell.bayer.com

    Dist. by: Bayer HealthCare LLC, Whippany, NJ 07981

    Distributed By:

    Cardinal Health

    Dublin, OH 43017

    L4532222-10225 / L4532222-20225

  • Principal Display Panel

    NDC 55154-5035-6

    MiraLAX®

    Polyethylene Glycol 3350,

    Powder for Solution, Osmotic Laxative

    6 PACKETS NET WT 0.5OZ (17g)

    3350 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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