Label: POLYETHYLENE GLYCOL 3350 powder, for solution

  • NDC Code(s): 72603-302-01, 72603-302-02, 72603-302-03, 72603-302-04
  • Packager: NorthStar Rx LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated February 19, 2025

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

  • Active Ingredient (in each dose)
    Polyethylene Glycol 3350 USP, 17g
  • 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 ...
  • 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: use once a day - stir and dissolve one packet of powder (17 g) in any 4 to 8 ...
  • Other information
    store at 20° to 25°C (68° to 77°F) tamper-evident: do not use if printed foil pouch is open or broken
  • Inactive ingredients
    None
  • Questions or comments?
    1-800-206-7821
  • SPL UNCLASSIFIED SECTION
    Packaged for: NorthStar Rx LLC - Memphis, TN 38141 - Packaged by: Novitium Pharma LLC - East Windsor, NJ 08520 - Rev 01/2025
  • PRINCIPAL DISPLAY PANEL
    NDC 72603-302-04 - Polyethylene Glycol 3350 - Powder for Solution, Osmotic Laxative - Relieves Occasional Constipation/Irregularity - Softens Stool - Dissolves in any Beverage ...
  • INGREDIENTS AND APPEARANCE
    Product Information