Label: MIRALAX- polyethylene glycol 3350 powder, for solution

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

Drug Label Information

Updated 04/14

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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

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

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  • Purpose

    Osmotic Laxative

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

    Polyethylene Glycol 3350, 17 g

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  • Purpose

    Osmotic Laxative

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  • Use

    • relieves occasional constipation (irregularity)
    • generally produces a bowel movement in 1 to 3 days
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  • 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.

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  • 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:
      • 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
      • use once a day
      • use no more than 7 days
    • children 16 years of age or under: ask a doctor
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  • 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
      • use once a day
      • use no more than 7 days
    • children 16 years of age or under: ask a doctor
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  • 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
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  • Inactive ingredients

    none

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  • Questions or comments?

    1-800-MiraLAX (1-800-647-2529) or www.MiraLAX.com

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  • SPL UNCLASSIFIED SECTION

    Distributed by MSD Consumer Care, Inc.,
    PO Box 377, Memphis, TN 38151 USA, a subsidiary of
    Merck & Co., Inc., Whitehouse Station, NJ USA.

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  • PRINCIPAL DISPLAY PANEL - 17 g × 10 Packet Carton

    10
    Packets

    NDC 11523-7268-3

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

    UNFLAVORED
    POWDER
    GRIT FREE

    • Relieves Occasional
      Constipation/Irregularity
    • Softens Stool

    NeatPAX®

    10 ONCE-DAILY DOSES

    10 PACKETS
    NET WT 0.5 OZ (17g) EACH

    PRINCIPAL DISPLAY PANEL - 17 g × 10 Packet Carton
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  • PRINCIPAL DISPLAY PANEL - 510 g Bottle Label

    NDC 11523-7234-4

    Original
    Prescription
    Strength

    MiraLAX®

    Polyethylene Glycol 3350
    Powder for Solution, Osmotic Laxative

    • Relieves Occasional
      Constipation (Irregularity)
    • Softens Stool

    30
    ONCE-DAILY
    DOSES

    NET WT 17.9 OZ (510 g)

    Principal Display Panel - 510 g Bottle Label
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  • PRINCIPAL DISPLAY PANEL - 17 g × 3 Packet Carton

    Trial
    Pack

    NDC 11523-7341-02

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

    UNFLAVORED
    POWDER
    GRIT FREE

    • Relieves Occasional
      Constipation/Irregularity
    • Softens Stool

    NeatPAX®

    3 ONCE-DAILY DOSES

    3 PACKETS
    NET WT 0.5 OZ (17g) EACH

    Principal Display Panel - 17 g × 3 Packet Carton
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  • PRINCIPAL DISPLAY PANEL - Twin Pack - 765 g Bottle Label

    Value
    Size

    NDC 11523-4357-1

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

    UNFLAVORED
    POWDER
    GRIT FREE

    • Relieves Occasional
      Constipation/Irregularity
    • Softens Stool

    45 ONCE-DAILY DOSES
    NET WT 26.9 OZ (765g)

    32660-01

    Principal Display Panel - Twin Pack - 765 g Bottle Label
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  • INGREDIENTS AND APPEARANCE
    MIRALAX 
    polyethylene glycol 3350 powder, for solution
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:11523-7268
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Polyethylene Glycol 3350 (UNII: G2M7P15E5P) (Polyethylene Glycol 3350 - UNII:G2M7P15E5P) Polyethylene Glycol 3350 17 g  in 17 g
    Product Characteristics
    Color WHITE (Colorless upon dissolution) Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:11523-7268-3 10 in 1 CARTON
    1 17 g in 1 PACKET
    2 NDC:11523-7268-8 24 in 1 CARTON
    2 17 g in 1 PACKET
    3 NDC:11523-7268-7 5 in 1 CARTON
    3 17 g in 1 PACKET
    4 NDC:11523-7268-4 765 g in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA022015 02/23/2009
    MIRALAX 
    polyethylene glycol 3350 powder, for solution
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:11523-7234
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Polyethylene Glycol 3350 (UNII: G2M7P15E5P) (Polyethylene Glycol 3350 - UNII:G2M7P15E5P) Polyethylene Glycol 3350 17 g  in 17 g
    Product Characteristics
    Color WHITE (Colorless upon dissolution) Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:11523-7234-1 17 g in 1 PACKET
    2 NDC:11523-7234-2 119 g in 1 BOTTLE, PLASTIC
    3 NDC:11523-7234-3 238 g in 1 BOTTLE, PLASTIC
    4 NDC:11523-7234-4 510 g in 1 BOTTLE, PLASTIC
    5 NDC:11523-7234-5 12 in 1 CARTON
    5 17 g in 1 PACKET
    6 NDC:11523-7234-6 17 g in 1 PACKET
    7 NDC:11523-7234-7 2 in 1 CARTON
    7 17 g in 1 PACKET
    8 NDC:11523-7234-8 72 in 1 CARTON
    8 17 g in 1 PACKET
    9 NDC:11523-7234-9 2 in 1 CELLO PACK
    9 510 g in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA022015 02/23/2009
    MIRALAX 
    polyethylene glycol 3350 powder, for solution
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:11523-7341
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Polyethylene Glycol 3350 (UNII: G2M7P15E5P) (Polyethylene Glycol 3350 - UNII:G2M7P15E5P) Polyethylene Glycol 3350 17 g  in 17 g
    Product Characteristics
    Color WHITE (Colorless upon dissolution) Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:11523-7341-1 612 g in 1 BOTTLE, PLASTIC
    2 NDC:11523-7341-2 3 in 1 CARTON
    2 17 g in 1 PACKET
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA022015 02/23/2009
    MIRALAX 
    polyethylene glycol 3350 powder, for solution
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:11523-4357
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Polyethylene Glycol 3350 (UNII: G2M7P15E5P) (Polyethylene Glycol 3350 - UNII:G2M7P15E5P) Polyethylene Glycol 3350 17 g  in 17 g
    Product Characteristics
    Color WHITE (colorless upon dissolution) Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:11523-4357-1 2 in 1 PACKAGE, COMBINATION
    1 765 g in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA022015 02/23/2009
    Labeler - MSD Consumer Care, Inc. (968091715)
    Establishment
    Name Address ID/FEI Business Operations
    Merck Sharp & Dohme Corp 040947439 MANUFACTURE(11523-7268, 11523-7234, 11523-7341, 11523-4357)
    Establishment
    Name Address ID/FEI Business Operations
    Catalent Pharma Solutions 078465146 PACK(11523-7268, 11523-7234, 11523-7341, 11523-4357)
    Establishment
    Name Address ID/FEI Business Operations
    Braintree Laboratories, Inc. 617357954 MANUFACTURE(11523-7234, 11523-7341) , PACK(11523-7234, 11523-7341)
    Establishment
    Name Address ID/FEI Business Operations
    New-Tech Packaging, Inc. 115281644 PACK(11523-7234, 11523-7268, 11523-7341, 11523-4357)
    Establishment
    Name Address ID/FEI Business Operations
    PTI Union LLC 807308858 MANUFACTURE(11523-7234, 11523-7341) , PACK(11523-7234, 11523-7341)
    Establishment
    Name Address ID/FEI Business Operations
    PTI Royston LLC 601006997 MANUFACTURE(11523-7268, 11523-7234, 11523-7341, 11523-4357) , PACK(11523-7268, 11523-7234, 11523-7341, 11523-4357)
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