Label: POLYETHYLENE GLYCOL 3350 powder, for solution

  • NDC Code(s): 62559-157-10, 62559-157-17, 62559-157-30
  • Packager: ANI Pharmaceuticals, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated May 17, 2024

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  • 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 week
  • 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 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 printed foil pouch is open or broken
  • Inactive ingredients

    None

  • Questions or comments?

    1-800-308-6755

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    ANI Pharmaceuticals, Inc.
    Baudette, MN 56623

    10198 Rev 05/21

  • PRINCIPAL DISPLAY PANEL

    NDC 62559-157-30
    Polyethylene Glycol 3350
    Powder for Solution,
    Osmotic Laxative

    •
    Relieves Occasional Constipation/Irregularity
    •
    Softens Stool

    Dissolves in any Beverage
    Sugar free

    30 Once-Daily Doses
    30 Packets NET WT 0.5 oz (17 g) Each

    30 Single Doses

    Compare to MiraLAX® Active Ingredient
    Carton-30pkt

  • INGREDIENTS AND APPEARANCE
    POLYETHYLENE GLYCOL 3350 
    polyethylene glycol 3350 powder, for solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62559-157
    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:62559-157-3030 in 1 CARTON03/24/2020
    1NDC:62559-157-1717 g in 1 PACKET; Type 0: Not a Combination Product
    2NDC:62559-157-10100 in 1 CARTON03/24/2020
    2NDC:62559-157-1717 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20285003/24/2020
    Labeler - ANI Pharmaceuticals, Inc. (145588013)
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