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

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  • 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 week
  • 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 beverage (cold, hot or room temperature) then drink
      • do not combine with starch-based thickeners used for difficulty swallowing
      • ensure that the powder is fully dissolved before drinking
      • do not drink if there are any clumps
      • do not use 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 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 India

    Code: TS/DRUGS/16/2014

  • 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
    Softens Stool
    Sugar-Free
    Dissolves in any Beverage

    COMPARE TO
    MiraLAX®
    active ingredient*

    100% Money
    Back Guarantee

    1 DOSE
    NET WT 0.5 OZ (17g)

    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 17 g Pouch Label

  • 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
    Softens Stool
    Sugar-Free
    Dissolves in Any Beverage

    COMPARE TO
    MiraLAX®
    active ingredient*

    100% Money
    Back Guarantee

    10 PRE-MEASURED, SINGLE DOSES                            10 PACKETS
    10 ONCE-DAILY DOSES                                                    NET WT 0.5 OZ (17g) EACH

    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 17 g Pouch Carton Label

  • INGREDIENTS AND APPEARANCE
    POLYETHYLENE GLYCOL 3350 
    polyethylene glycol 3350 powder, for solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0699
    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 17 g
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70000-0699-210 in 1 CARTON11/08/2024
    1NDC:70000-0699-117 g in 1 PACKET; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20901711/08/2024
    Labeler - LEADER/ CARDINAL HEALTH 110, INC. (063997360)
    Registrant - Aurohealth LLC (078728447)
    Establishment
    NameAddressID/FEIBusiness Operations
    APL HEALTHCARE LIMITED650844777ANALYSIS(70000-0699) , MANUFACTURE(70000-0699)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aurobindo Pharma Limited918917642ANALYSIS(70000-0699) , MANUFACTURE(70000-0699)
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