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 November 7, 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 seal under cap, printed with "SEALED for YOUR PROTECTION" is missing, open or broken
  • Inactive ingredients

    none

  • Questions or comments?

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

  • .

    Overbagged with 6 x 17g packets per bag, NDC 55154-5035-6

    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.

    Distributed By:

    Cardinal Health

    Dublin, OH 43017

    L4532222-11025 / L4532222-21025

  • Principal Display Panel

    NDC 55154-5035-6

    MiraLAX®

    Polyethylene Glycol 3350,

    Powder for Solution, Osmotic Laxative

    6 PACKETS NET WT 0.5OZ (17g)

    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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