Label: POLYETHYLENE GLYCOL 3350 powder, for solution

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated January 17, 2024

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  • Active Ingredient (in each sachet)

    Polyethylene Glycol 3350, NF 17g

  • Purpose

    Laxative

  • Uses

    •
    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 of 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

    •
    do not take more than directed unless advised by your doctor
    •
    adults and children 17 years of age and older:
    •
    stir and dissolve one sachet of powder (17 g) in any 4 to 8 ounces of beverage (cold, hot or room temperature)
    •
    drink the solution.
    •
    use once a day
    •
    use no more than 7 days
    •
    children 16 years of age or under: ask a doctor

    Other Information

    •
    store at 20° - 25°C (68° - 77°F)
    •
    do not use if foil is open or broken.
  • Inactive Ingredients

    none

    Questions or comments?

    1-800-707-4621 or www.americanhealthpackaging.com

    © 2019 & Distributed by
    American Health Packaging
    Columbus, Ohio 43217 USA

    All rights reserved.

    1037831/1037832

    Distributed By:

    Cardinal Health

    Dublin, OH 43017

    L5568654-10124

    L5568654-20124

  • Principal Display Panel

    Healthylax®

    Polyethylene Glycol 3350 NF

    Powder for Oral Laxative Solution

    7 Sachets 0.6 Oz (17 g) Each

    Bag Label
  • INGREDIENTS AND APPEARANCE
    POLYETHYLENE GLYCOL 3350 
    polyethylene glycol 3350 powder, for solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55154-8184(NDC:60687-431)
    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
    Inactive Ingredients
    Ingredient NameStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Colorwhite (Colorless upon dissolution) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55154-8184-57 in 1 BAG04/15/2019
    117 g in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20392804/15/2019
    Labeler - Cardinal Health 107, LLC (118546603)
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