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

  • NDC Code(s): 14539-150-20
  • Packager: Emcure Pharmaceuticals USA Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated 01/13

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  • INDICATIONS & USAGE

    Use

    • relieves occasional constipation (irregularity)
    • generally produces a bowel movement in 1 to 3 days
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  • 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 of 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 or 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
    • side effects occur. You may report side effects to FDA at 1-800-FDA-1088

    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. Close
  • 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:
      • fill to top of white section in cap which is marked to indicate the correct dose (17g)
      • 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 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

     

    Close
  • Principal display panel


    Base panel
    Polyethylene Glycol 3350 NF
    Powder for Solution, Osmotic Laxative
     
    • Relieves Occasional Constipation (Irregularity)
    • Softens Stools

     
    NDC 14539-150-20
    Original Prescription Strength
    Dissolves in Any Beverage
    30 ONCE-DAILY DOSES
    Net Wt. 510 g
    Polyethylene Glycol 3350 NF increases frequency of bowel movements and softens the stools.
     
    Manufactured By:
    Emcure Pharmaceuticals USA Inc.
    21/B Cotters Lane
    East Brunswick, NJ 08816, USA.
     
    Top panel
    Polyethylene Glycol 3350 NF
    Powder for Solution, Osmotic Laxative
     
    • Relieves Occasional Constipation (Irregularity)
    • Softens Stools

     
    NDC 14539-150-20
    PEEL HERE
    Original Prescription Strength
    30 ONCE-DAILY DOSES
    Net Wt. 510 g
     
    Drug Facts
    Active ingredient (in each dose) Purpose
    Polyethylene Glycol 3350,
    17 g (cap filled to line).............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
    • side effects occur. You may report side effects to FDA at 1-800-FDA-1088

     

    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:
      • fill to top of white section in cap which is marked to indicate the correct dose (17g)
      • stir and dissolve in any 4 to 8 ounces of beverage (cold, hot or room temperature) then drink
      • use once a day
      • use not more than 7 days
    • children 16 years of age or under: ask a doctor 

    Other information
    • store at 20o- 25 oC (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
     
    Label

     
     
     
     
     
      Close
  • INGREDIENTS AND APPEARANCE
    POLYETHYLENE GLYCOL 3350 
    polyethylene glycol 3350 powder, for solution
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:14539-150
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    POLYETHYLENE GLYCOL 3350 (POLYETHYLENE GLYCOL 3350) POLYETHYLENE GLYCOL 3350 17 g
    Product Characteristics
    Color WHITE (Colorless upon dissolution) Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:14539-150-20 30 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA202071 09/28/2011
    Labeler - Emcure Pharmaceuticals USA Inc. (189630168)
    Establishment
    Name Address ID/FEI Business Operations
    Emcure Pharmaceuticals USA Inc. 189630168 ANALYSIS(14539-150), MANUFACTURE(14539-150)
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