Label: MIRALAX- polyethylene glycol 3350 powder, for solution

  • NDC Code(s): 11523-4357-1, 11523-4357-2, 11523-4357-3, 11523-4357-5, view more
    11523-7234-1, 11523-7234-2, 11523-7234-3, 11523-7234-4, 11523-7234-5, 11523-7234-6, 11523-7234-9, 11523-7268-3, 11523-7268-4, 11523-7268-7, 11523-7268-8, 11523-7268-9, 11523-7341-1, 11523-7341-2
  • Packager: Bayer HealthCare LLC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated December 4, 2023

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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:
      • 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 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:
      • 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 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)

  • PRINCIPAL DISPLAY PANEL - 17 g × 20 Packet Carton

    20

    Single Doses

    #1 DOCTOR RECOMMENDED BRAND

    MiraLAX ®

    Polyethylene Glycol 3350, Powder for Solution, Osmotic Laxative

    Mix-In Pax ®

    • Relieves Occasional Constipation/Irregularity
    • Softens Stool

    20

    ONCE-DAILY DOSES

    Bayer

    Unflavored Powder Dissolves in ANY Beverage!

    UNFLAVORED
    POWDER
    GRIT FREE

    20 PACKETS

    NET WT 0.5 OZ

    (17g) EACH

    20ct Carton

  • PRINCIPAL DISPLAY PANEL - 17 g × 10 Packet Carton

    10

    Single Doses

    #1 DOCTOR RECOMMENDED BRAND

    MiraLAX ®
    Polyethylene Glycol 3350, Powder for Solution, Osmotic Laxative

    Mix-In Pax ®

    • Relieves Occasional Constipation/Irregularity
    • Softens Stool

    10

    ONCE-DAILY DOSES

    Bayer

    Unflavored Powder Dissolves in ANY Beverage!

    UNFLAVORED
    POWDER
    GRIT FREE

    10 PACKETS
    NET WT 0.5 OZ

    (17g) EACH

    10ct Carton

  • PRINCIPAL DISPLAY PANEL - 30 Dose (510 g) Bottle Label

    Easy to Pour Bottle

    #1 DOCTOR RECOMMENDED BRAND

    MiraLAX ®

    Polyethylene Glycol 3350, Powder for Solution, Osmotic Laxative

    UNFLAVORED

    POWDER

    GRIT FREE

    • Relieves Occasional Constipation/Irregularity
    • Softens Stool

    Bayer

    30 ONCE-DAILY DOSES

    NET WT 17.9 OZ (510 g)

    30 Front

    30 Dose - Back

  • PRINCIPAL DISPLAY PANEL - Twinpack 2x34 Dose (578 g) Bottle Label

    Twin Pack!

    2 x 34 Doses

    Easy to Pour Bottle

    MiraLAX ®

    Polyethylene Glycol 3350, Powder for Solution, Osmotic Laxative

    #1 DOCTOR RECOMMENDED BRAND

    • Relieves Occasional Constipation/Irregularity
    • Softens Stool

    UNFLAVORED

    POWDER

    GRIT FREE

    Bayer

    34 ONCE-DAILY DOSES

    NET WT 20.4 OZ (578 g)

    34 Dose Front

    34 Dose Back

  • INGREDIENTS AND APPEARANCE
    MIRALAX 
    polyethylene glycol 3350 powder, for solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)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:11523-7268-310 in 1 CARTON02/01/2007
    117 g in 1 PACKET; Type 0: Not a Combination Product
    2NDC:11523-7268-824 in 1 CARTON02/01/2007
    217 g in 1 PACKET; Type 0: Not a Combination Product
    3NDC:11523-7268-75 in 1 CARTON02/01/200701/01/2015
    317 g in 1 PACKET; Type 0: Not a Combination Product
    4NDC:11523-7268-4765 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/01/2007
    5NDC:11523-7268-920 in 1 CARTON02/01/2007
    517 g in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02201502/01/2007
    MIRALAX 
    polyethylene glycol 3350 powder, for solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11523-7234
    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:11523-7234-117 g in 1 PACKET; Type 0: Not a Combination Product02/01/2007
    2NDC:11523-7234-2119 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/01/2007
    3NDC:11523-7234-3238 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/01/2007
    4NDC:11523-7234-4510 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/01/2007
    5NDC:11523-7234-512 in 1 CARTON02/01/200701/01/2012
    517 g in 1 PACKET; Type 0: Not a Combination Product
    6NDC:11523-7234-617 g in 1 PACKET; Type 0: Not a Combination Product02/01/2007
    7NDC:11523-7234-92 in 1 CELLO PACK02/01/200701/01/2014
    7510 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02201502/01/2007
    MIRALAX 
    polyethylene glycol 3350 powder, for solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11523-7341
    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:11523-7341-1612 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/01/2007
    2NDC:11523-7341-23 in 1 CARTON02/01/2007
    217 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02201502/01/2007
    MIRALAX 
    polyethylene glycol 3350 powder, for solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11523-4357
    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:11523-4357-12 in 1 PACKAGE, COMBINATION02/01/200701/01/2018
    1765 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:11523-4357-32 in 1 PACKAGE, COMBINATION02/01/2007
    2578 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    3NDC:11523-4357-524 in 1 CARTON05/01/2018
    317 g in 1 PACKET; Type 0: Not a Combination Product
    4NDC:11523-4357-22 in 1 CARTON02/01/2007
    420 in 1 CARTON
    417 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02201502/01/2007
    Labeler - Bayer HealthCare LLC. (112117283)
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