Label: POLYETHYLENE GLYCOL 3350 powder, for solution

  • NDC Code(s): 68001-607-55, 68001-607-69
  • Packager: BluePoint Laboratories
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated January 31, 2024

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

  • ACTIVE INGREDIENT (IN EACH DOSE)

    Polyethylene Glycol 3350, 17 g (cap filled to 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
    • 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 difficult 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° to 25°C (68° to 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 1-888-588-1418.

  • PRINCIPAL DISPLAY PANEL

    Polyethylene glycol 3350 powder for oral solution 238g bottle label

    bottlelabelfront

    bottlebacklabel

    Polyethylene glycol 3350 powder for oral solution 510g bottle label

    510g front label510g back label

    Polythylene Glycol Powder 238g Label Page 1 Rev 012024

    Polythylene Glycol Powder 238g Label Page 1 Rev 012024

    Polythylene Glycol Powder 238g Label Page 2 Rev 012024

    Polythylene Glycol Powder 238g Label Page 2 Rev 012024

    Polythylene Glycol Powder 510g Label Page 1 Rev 012024

    Polythylene Glycol Powder 510g Label Page 1 Rev 012024

    Polythylene Glycol Powder 510g Label Page 2 Rev 012024

    Polythylene Glycol Powder 510g Label Page 2 Rev 012024

  • INGREDIENTS AND APPEARANCE
    POLYETHYLENE GLYCOL 3350 
    polyethylene glycol 3350 powder, for solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68001-607
    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:68001-607-55238 g in 1 BOTTLE; Type 0: Not a Combination Product10/01/2023
    2NDC:68001-607-69510 g in 1 BOTTLE; Type 0: Not a Combination Product10/01/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21499010/01/2023
    Labeler - BluePoint Laboratories (985523874)
    Establishment
    NameAddressID/FEIBusiness Operations
    Annora Pharma Private Limited650980746manufacture(68001-607)