Label: MIRALAX ORANGE FLAVOR- polyethylene glycol 3350 powder, for solution

  • NDC Code(s): 11523-0122-1, 11523-0122-2
  • Packager: Bayer HealthCare LLC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated October 3, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each dose)

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

  • 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(1-800-222-1222).

  • 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:
      • use once a day
      • fill to top of white section in cap which is marked to indicate the correct dose (17 g)
      • stir and dissolve 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 printed foil seal under cap is missing, open or broken
  • Inactive ingredients

    natural and artificial orange flavor, sucralose

  • Questions or comments?

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

  • PRINCIPAL DISPLAY PANEL - 7 Dose Bottle

    MiraLAX ®

    Polyethylene Glycol 3350, Powder for Solution, Osmotic Laxative

    Relieves Occasional Constipation/Irregularity
    Softens Stool
    Grit-Free Powder
    Sugar-Free & Dye-Free

    ORANGE FLAVOR

    7 ONCE-DAILY DOSES

    NET WT 4.1 OZ (119 g)

    Bayer

    MiraLAX Orange 7 dose Front LabelMiraLAX Orange 7 dose Back Label

  • INGREDIENTS AND APPEARANCE
    MIRALAX ORANGE FLAVOR 
    polyethylene glycol 3350 powder, for solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11523-0122
    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
    Inactive Ingredients
    Ingredient NameStrength
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    Colorwhite (White or almost white solid with a waxy or paraffin-like appearance) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11523-0122-2119 g in 1 BOTTLE; Type 0: Not a Combination Product09/15/2023
    2NDC:11523-0122-1238 g in 1 BOTTLE; Type 0: Not a Combination Product09/15/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09068509/15/2023
    Labeler - Bayer HealthCare LLC. (112117283)
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