Label: POLYETHYLENE GLYCOL 3350- polyethylene glycol 3350 powder, for solution

  • NDC Code(s): 69230-324-32, 69230-324-33, 69230-324-34
  • Packager: Camber Consumer Care Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated September 12, 2022

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

  • ACTIVE INGREDIENT (IN EACH DOSE)


    (Bottle Only)            


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


    (Packet Only)            


    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 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

    (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
       • ensure that the powder is fully dissolved before drinking 
       • do not drink if there are any clumps
       • use once a day
       • use no more than 7 days
    • children 16 years of age or under: ask a doctor

      (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
      • ensure that the powder is fully dissolved before drinking 
      • do not drink if there are any clumps
      • use once a day
      • use no 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 carton label

    polyethylene


  • INGREDIENTS AND APPEARANCE
    POLYETHYLENE GLYCOL 3350  
    polyethylene glycol 3350 powder, for solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69230-324
    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:69230-324-327 in 1 CARTON04/14/2021
    117 g in 1 PACKET; Type 0: Not a Combination Product
    2NDC:69230-324-3310 in 1 CARTON04/14/2021
    217 g in 1 PACKET; Type 0: Not a Combination Product
    3NDC:69230-324-34119 g in 1 BOTTLE; Type 0: Not a Combination Product04/14/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21499004/14/2021
    Labeler - Camber Consumer Care Inc (079539968)
    Establishment
    NameAddressID/FEIBusiness Operations
    Annora Pharma Private Limited650980746manufacture(69230-324)