Label: POLYETHYLENE GLYCOL 3350 powder, for solution

  • NDC Code(s): 70000-0699-1, 70000-0699-2
  • Packager: LEADER/ CARDINAL HEALTH 110, INC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated November 27, 2024

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

  • Drug Facts
    Active ingredient (in each dose) Polyethylene Glycol 3350, USP 17 grams
  • 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
    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 DOCTOR/PHARMACIST
    Ask a doctor or pharmacist before use if you are taking a prescription drug
  • WHEN USING
    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 ...
  • PREGNANCY OR BREAST FEEDING
    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 (1-800-222-1222) 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 ounces of ...
  • Other information
    store at 20° to 25°C (68° to 77°F) tamper-evident: do not use if foil is open or broken
  • Inactive ingredients
    none - Questions or comments? call 1-855-274-4122 - DISTRIBUTED BY - CARDINAL HEALTH - DUBLIN, OHIO 43017 - www.myleader.com  1-800-200-6313 - Essential to Care™ since 1979 - Made in ...
  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 17 g Pouch Label
    LEADERTM - NDC 70000-0699-1 - Grit-Free | Unflavored Powder Packet - Polyethylene - Glycol 3350 - Powder for Oral Solution - Osmotic Laxative - Relieves Occasional - Constipation/Irregularity ...
  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 17 g Pouch Carton Label
    LEADERTM - NDC 70000-0699-2 - Grit-Free | Unflavored Powder Packets - Polyethylene Glycol 3350 - Powder for Oral Solution | Osmotic Laxative - Relieves Occasional Constipation/Irregularity ...
  • INGREDIENTS AND APPEARANCE
    Product Information