Label: POLYETHYLENE GLYCOL powder, for suspension

  • NDC Code(s): 68001-505-55, 68001-505-69
  • Packager: BluePoint Laboratories
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated September 20, 2021

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  • ACTIVE INGREDIENT

    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 THE REACH OF CHILDREN

    In case of overdose, get medical help or contact a POISON CONTROL CENTER right away. (1-800-222-1222)

  • 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.
    • adults and children 17 years of age and older:
    • use once a day
    • fill to top of line 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 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?

    1-866-403-7592

  • Package Label - Principal Display Panel

    NDC: 68001-505-55

    Original Prescription Strength

    Polyethylene Glycol 3350

    Powder for Solution, 17g/dose

    Osmotic Laxative

    14 ONCE-DAILY DOSES

    NET WT 8.3 OZ (238 g)

    Label

  • INGREDIENTS AND APPEARANCE
    POLYETHYLENE GLYCOL 
    polyethylene glycol powder, for suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68001-505
    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
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68001-505-55238 g in 1 BOTTLE; Type 0: Not a Combination Product06/18/2021
    2NDC:68001-505-69510 g in 1 BOTTLE; Type 0: Not a Combination Product06/18/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09107706/18/2021
    Labeler - BluePoint Laboratories (985523874)
    Establishment
    NameAddressID/FEIBusiness Operations
    Novel Laboratories Inc.793518643analysis(68001-505) , manufacture(68001-505) , pack(68001-505)
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