Label: POLYETHYLENE GLYCOL 3350 powder, for solution

  • NDC Code(s): 0904-6931-26, 0904-6931-76, 0904-6931-81, 0904-6931-86
  • Packager: Major Pharmaceuticals
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated April 28, 2023

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  • Active ingredient (in each dose)

    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 or 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 get diarrhea
    • you need to use a laxative for longer than 1 week
    • you have rectal bleeding or your nausea, bloating, cramping or abdominal pain gets worse. These may be signs of a serious condition.

    If pregnant or breast-feeding,

    ask a health professional before use.

    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away.

  • Directions

    • 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 is open or broken
  • Inactive ingredients

    none

  • Questions or comments?

    1-800-616-2471

  • Principal display panel

    NDC 0904-6931-26

    Compare to MiraLAX®
    active ingredient*

    MAJOR®

    PEG3350

    Polyethylene Glycol 3350
    Powder for Oral Solution
    Osmotic Laxative

    • Relieves Occasional Constipation (Irregularity)
    • Softens Stool

    Dissolves in Any Beverage
    Sugar Free
    Unflavored

    14 Once-Daily Doses
    NET WT 0.5 OZ (17 g) Each

    TAMPER-EVIDENT: DO NOT USE IF
    FOIL IS OPEN OR BROKEN

    *This product is not manufactured or distributed by Bayer HealthCare LLC,
    owner of the registered trademark MiraLAX®.

    Distributed by MAJOR® PHARMACEUTICALS
    Indianapolis, IN 46268
    www.majorpharmaceuticals.com
    Rev. 03/22                             M-17                              Re-order No. 701066

    Product of India                                                      50844      REV0222D72648

    Major 44-726

    Major 44-726

  • INGREDIENTS AND APPEARANCE
    POLYETHYLENE GLYCOL 3350 
    polyethylene glycol 3350 powder, for solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-6931
    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:0904-6931-8617 g in 1 PACKET; Type 0: Not a Combination Product06/30/2019
    2NDC:0904-6931-2614 in 1 CARTON06/30/2019
    217 g in 1 PACKET; Type 0: Not a Combination Product
    3NDC:0904-6931-7630 in 1 CARTON06/30/2019
    317 g in 1 PACKET; Type 0: Not a Combination Product
    4NDC:0904-6931-81100 in 1 CARTON06/30/2019
    417 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20392806/30/2019
    Labeler - Major Pharmaceuticals (191427277)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464pack(0904-6931)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837pack(0904-6931)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305pack(0904-6931)
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