Label: POLYETHYLENE GLYCOL 3350 powder, for solution

  • NDC Code(s): 58602-805-01, 58602-805-02, 58602-805-03, 58602-805-04
  • Packager: Aurohealth LLC
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated June 8, 2021

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  • Drug Facts

    Active ingredient (in each dose)

    Polyethylene Glycol 3350, USP 17 grams (cup filled to the indicated 17 grams line)

  • 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
    • this product is supplied with a dosing cup marked to contain 17 grams of powder when filled to the indicated line
    • adults and children 17 years of age and older:
      • use once a day
      • fill to the indicated 17 grams line on cup which is marked to indicate the correct dose 17 grams
      • stir and dissolve 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 no 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 seal under cap, printed with "SEALED for YOUR PROTECTION" is missing, open or broken
  • Inactive ingredients

    none

    Questions or comments?

    call 1-855-274-4122
    Distributed by:
    AUROHEALTH LLC
    279 Princeton-Hightstown Road
    East Windsor, NJ 08520

    Made in India

    Code: TS/DRUGS/19/1993

  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 119 g Bottle Label

    AUROHEALTH

    NDC 58602-805-01

    Compare to active ingredient
    of MiraLax®*

    Polyethylene Glycol 3350
    Powder for Oral Solution

    Osmotic Laxative

    • Relieves Occasional Constipation/Irregularity
    • Softens Stool

    UNFLAVORED POWDER - GRIT FREE

    7 ONCE-DAILY DOSES            NET WT 4.1 OZ (119 g)
     
    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 119 g Bottle Label
     

  • INGREDIENTS AND APPEARANCE
    POLYETHYLENE GLYCOL 3350 
    polyethylene glycol 3350 powder, for solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-805
    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:58602-805-01119 g in 1 BOTTLE, PLASTIC; Type 1: Convenience Kit of Co-Package04/09/2018
    2NDC:58602-805-02238 g in 1 BOTTLE, PLASTIC; Type 1: Convenience Kit of Co-Package04/09/2018
    3NDC:58602-805-03510 g in 1 BOTTLE, PLASTIC; Type 1: Convenience Kit of Co-Package04/09/2018
    4NDC:58602-805-04850 g in 1 BOTTLE, PLASTIC; Type 1: Convenience Kit of Co-Package04/09/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20901704/09/2018
    Labeler - Aurohealth LLC (078728447)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aurobindo Pharma Limited918917642ANALYSIS(58602-805) , MANUFACTURE(58602-805)
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