Label: POLYETHYLENE GLYCOL 3350, NF POWDER FOR SOLUTION, LAXATIVE powder, for solution

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated December 1, 2010

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

  • Active ingredient

    Polyethylene Glycol 3350, 17g (cap filled to the top)

  • Purpose

    Laxative

  • KEEP OUT OF REACH OF CHILDREN

  • INDICATIONS & USAGE

  • Uses

    • 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 cup designed to contain 17 grams of powder when filled to the top rim.
    • adults and children 17 years of age and older
      • fill to the top of the bottle cap which will provide the correct dose (17 g)
      • stir and dissolve in any 4 to 8 ounces of beverage (cold, hot or room temperature) then drink.
      • use once a day
      • use no more than 7 days
    • children 16 years of age or younger, ask a doctor
  • Other Information

    • Store at 20O - 25O C (68O - 77O 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?

    For serious adverse events call: 

    1-888-710-0006

  • Principal Display

    Polyethylene Glycol 3350 NF

  • INGREDIENTS AND APPEARANCE
    POLYETHYLENE GLYCOL 3350, NF POWDER FOR SOLUTION, LAXATIVE 
    polyethylene glycol 3350, nf powder for solution, laxative powder, for solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21695-598(NDC:0722-7116)
    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 1 g
    Inactive Ingredients
    Ingredient NameStrength
    AIR (UNII: K21NZZ5Y0B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:21695-598-25255 g in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09081210/07/2009
    Labeler - Rebel Distributors Corp (118802834)
    Establishment
    NameAddressID/FEIBusiness Operations
    Rebel Distributors Corp118802834RELABEL, REPACK