Label: POLYETHYLENE GLYCOL 3350 powder, for solution

  • NDC Code(s): 51991-961-58, 51991-962-57
  • Packager: Breeckenridge Pharmaceutical, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated October 4, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each dose)

    Polyethylene Glycol 3350, 17 g (cup filled to the indicated "17 GRAMS" 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 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 have rectal bleeding or your nausea, bloating, 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 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
    • this product is supplied with a dosing cup marked to contain 17 grams of powder when filled to the indicated line
    • adults and children 17 years of age and older:
      • use once a day
      • fill to the indicated "17 GRAMS" line on cup 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 foil seal under cap, printed with "SEALED for YOUR PROTECTION" is missing, open or broken
  • Inactive ingredients

    none

  • Questions or Comments?

    call: 1-800-367-3395

  • SPL UNCLASSIFIED SECTION

    Manufactured by:
    LGM Pharma Solutions, LLC
    Irvine, CA 92614

    Distributed by:
    Breckenridge Pharmaceutical, Inc.
    Berlin, CT 06037

  • PRINCIPAL DISPLAY PANEL - 238 g Bottle Label

    NDC 51991-961-58

    Polyethylene Glycol
    3350, NF

    Powder for Solution,
    Osmotic Laxative

    • Relieves Occasional
      Constipation / Irregularity
    • Softens Stool
    • Unflavored Powder
    • Sugar Free

    NET WT. 8.3 OZ (238 g)
    14 ONCE - DAILY DOSES

    breckenridge
    A Towa
    Company

    Principal Display Panel - 238 g Bottle Label
  • PRINCIPAL DISPLAY PANEL - 510 g Bottle Label

    NDC 51991-962-57

    Polyethylene Glycol
    3350, NF

    Powder for Solution,
    Osmotic Laxative

    • Relieves Occasional
      Constipation/ Irregularity
    • Softens Stool
    • Unflavored Powder
    • Sugar Free

    NET WT 17.9 OZ (510 g)
    30 ONCE - DAILY DOSES

    breckenridge
    A Towa
    Company

    Principal Display Panel - 510 g Bottle Label
  • INGREDIENTS AND APPEARANCE
    POLYETHYLENE GLYCOL 3350 
    polyethylene glycol 3350 powder, for solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51991-961
    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
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51991-961-58238 g in 1 BOTTLE; Type 0: Not a Combination Product03/27/201909/30/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09081203/27/201909/30/2024
    POLYETHYLENE GLYCOL 3350 
    polyethylene glycol 3350 powder, for solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51991-962
    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
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51991-962-57510 g in 1 BOTTLE; Type 0: Not a Combination Product03/27/201907/31/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09081203/27/201909/30/2024
    Labeler - Breeckenridge Pharmaceutical, Inc. (150554335)
    Establishment
    NameAddressID/FEIBusiness Operations
    LGM Pharma Solutions, LLC117549200MANUFACTURE(51991-961, 51991-962)
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