Label: POLYETHYLENE GLYCOL 3350 powder, for solution

  • NDC Code(s): 60687-431-27, 60687-431-92, 60687-431-98, 60687-431-99
  • Packager: American Health Packaging
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated August 18, 2023

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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:
    • use once a day
    • stir and dissolve one sachet 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° - 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

    © 2023 & Distributed by
    American Health Packaging
    Columbus, Ohio 43217 USA

    All rights reserved.

    1037831/1037832/1049041

  • Package/Label Display Panel - Carton - 17 g - 14UD

    17 g Healthylax Carton (14 Sachet)

    NDC 60687- 431-98

    healthylax ®
    POLYETHYLENE GLYCOL 3350 NF
    Powder for Oral Laxative Solution

    14 SACHETS
    Net Wt. 0.6 OZ (17g) EACH

    Distributed by American Health Packaging, Columbus, Ohio 43217

  • PACKAGE/LABEL DISPLAY PANEL - CARTON - 17 G - 30UD

    17 g healthylax Carton - 30UD

    NDC 60687- 431-27

    healthylax ®
    POLYETHYLENE GLYCOL 3350 NF
    Powder for Oral Laxative Solution

    30 SACHETS
    Net Wt. 18 OZ (510g)

    Distributed by American Health Packaging, Columbus, Ohio 43217

  • Package/Label Display Panel - Carton - 17 g - 100UD

    100 Ct Healthylax Carton

    NDC 60687- 431-92

    healthylax ®
    P     OLYETHYLENE GLYCOL 3350 NF
    Powder for Oral Laxative Solution

    100 - 17 g SACHETS
    Net Wt. 0.6 OZ (1700g)

    Distributed by American Health Packaging, Columbus, Ohio 43217

  • Package/Label Display Panel – Sachet – 17 g

    17 g HealthyLax Sachet

    NDC 60687- 431-99

    healthylax ®
    POLYETHYLENE GLYCOL 3350 NF
    Powder for Oral Laxative Solution

    Net Wt. 0.6 OZ (17g)

    Distributed by American Health Packaging, Columbus, Ohio 43217

  • INGREDIENTS AND APPEARANCE
    POLYETHYLENE GLYCOL 3350 
    polyethylene glycol 3350 powder, for solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)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:60687-431-9814 in 1 CARTON05/29/2019
    1NDC:60687-431-9917 g in 1 POUCH; Type 0: Not a Combination Product
    2NDC:60687-431-92100 in 1 CARTON02/26/2020
    2NDC:60687-431-9917 g in 1 POUCH; Type 0: Not a Combination Product
    3NDC:60687-431-2730 in 1 CARTON09/15/2023
    3NDC:60687-431-9917 g in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20392805/29/2019
    Labeler - American Health Packaging (929561009)
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