Label: POLYETHYLENE GLYCOL 3350 powder, for solution

  • NDC Code(s): 72657-196-16
  • Packager: GLENMARK THERAPEUTICS INC., USA
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated December 2, 2024

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

View All Sections
  • Polyethylene Glycol 3350, Powder for Solution

    Drug Facts

  • Active ingredient (in each dose) (Can only)

    Polyethylene Glycol 3350, 17 g (cap filled to line)

  • Purpose

    Osmotic Laxative

  • Active ingredient (in each dose) (Packet Only)

    Polyethylene Glycol 3350, 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 the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

  • Directions (Can Only)

    •
    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:
    o
    use once a day
    o
    fill to top of white section in cap which is marked to indicate the correct dose (17 g)
    o
    stir and dissolve in any 4 to 8 ounces of beverage (cold, hot or room temperature) then drink
    o
    do not combine with starch-based thickeners used for difficulty swallowing
    o
    ensure that the powder is fully dissolved before drinking
    o
    do not drink if there are any clumps
    o
    do not use more than 7 days
    •
    children 16 years of age or under: ask a doctor

    Directions (Packet Only)

    •
    do not take more than directed unless advised by your doctor
    •
    adults and children 17 years of age and older:
    o
    use once a day
    o
    stir and dissolve one packet of powder (17 g) in any 4 to 8 ounces of beverage (cold, hot or room temperature) then drink
    o
    do not combine with starch-based thickeners used for difficulty swallowing
    o
    ensure that the powder is fully dissolved before drinking
    o
    do not drink if there are any clumps
    o
    do not use 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

  • Questions or comments?

    Call weekdays 9 AM to 5 PM at 1 (888) 721-7115

    Polyethylene Glycol 3350 powder for solution increases frequency of bowel movements and softens the stool.

    Distributed by

    Glenmark Therapeutics Inc., USA

    Mahwah, NJ 07430

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 72657-196-16Polyethylene Glycol 3350

    Powder for Solution

    Osmotic Laxative

    •
    Relieves Occasional Constipation (Irregularity)
    •
    Softens Stool
    •
    TAMPER-EVIDENT: do not use if printed foil seal under cap is missing, open or brokenUnflavoredf
    •
    Sugar Free
    •
    Dissolves in Any Beverage

    45 ONCE-DAILY DOSES

    NET WT 26.9 OZ (765 g) EACH

    45s Label front

    image1front

    45s Label back

    image2
    image3
    image4
  • INGREDIENTS AND APPEARANCE
    POLYETHYLENE GLYCOL 3350 
    polyethylene glycol 3350 powder, for solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72657-196
    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
    ColorWHITE (Colorless upon dissolution) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72657-196-16765 g in 1 CAN; Type 0: Not a Combination Product09/19/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20392809/19/2024
    Labeler - GLENMARK THERAPEUTICS INC., USA (969085666)
    Establishment
    NameAddressID/FEIBusiness Operations
    Strides Pharma Science Limited918513263ANALYSIS(72657-196) , MANUFACTURE(72657-196) , PACK(72657-196)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials

More Info on this Drug

Get Label RSS Feed, View NDC Code(s)NEW!