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

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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 LABEL 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 (Polyethylene Glycol 3350) 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 LABEL 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 (Polyethylene Glycol 3350) 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 LABEL 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 (Polyethylene Glycol 3350) 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 LABEL 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 (Polyethylene Glycol 3350) 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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