Label: POLYETHYLENE GLYCOL- 3350 powder, for solution

  • NDC Code(s): 51079-306-01, 51079-306-30
  • Packager: Mylan Institutional Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated August 14, 2019

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

  • Active ingredient (in each dose)

    Polyethylene Glycol 3350, USP, 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

    • do not take more than directed unless advised by your doctor
    • adults and children 17 years of age and older:
      • stir and dissolve the contents of one pouch (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 no 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 pouch is damaged or torn
    • keep carton for future reference
    • for institutional use only
  • Inactive ingredients

    none

  • Questions or comments?

    1-877-4-INFO-RX (1-877-446-3679)

    Manufactured for:
    Mylan Institutional Inc.
    Rockford, IL 61103 U.S.A.

    MII306-30:R6

  • Principal Display Panel

    NDC 51079-306-30

    Polyethylene Glycol 3350, USP
    Powder for Solution,
    Osmotic Laxative

    • Relieves Occasional Constipation/Irregularity
    • Softens Stool

     

    • Unflavored
    • Powder
    • Grit Free
    • Sugar Free
    • Dissolves in Any Beverage

    This carton contains 30 single-dose pouches.
    Each pouch contains 17 grams of
    polyethylene glycol 3350, USP powder.

    For institutional use only.     30 Single-Dose Pouches

    Polyethylene Glycol 3350, USP Powder for Solution, Osmotic Laxative Carton Label
  • INGREDIENTS AND APPEARANCE
    POLYETHYLENE GLYCOL (3350) 
    polyethylene glycol (3350) powder, for solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51079-306
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POLYETHYLENE GLYCOL 3500 (UNII: FVS1AZD90Y) (POLYETHYLENE GLYCOL 3500 - UNII:FVS1AZD90Y) POLYETHYLENE GLYCOL 350017 g  in 17 g
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51079-306-3030 in 1 CARTON10/12/2009
    1NDC:51079-306-0117 g in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07891510/12/2009
    Labeler - Mylan Institutional Inc. (039615992)