EASYLAX (POLYETHYLENE GLYCOL) POWDER [MARC GLASSMAN, INC.]

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EASYLAX (POLYETHYLENE GLYCOL) POWDER [MARC GLASSMAN, INC.]
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NDC 68998-465-83
Set ID c22fd883-7d17-43c6-8bae-5b669064db5d
Category HUMAN OTC DRUG LABEL
Packager Marc Glassman, Inc.
Generic Name
Product Class
Product Number
Application Number ANDA091077
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  • Active ingredient (in each dose)

    Polyethylene Glycol 3350,

    17 g (cap filled to line)

  • Purpose

    Osmotic 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, vomitting 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 (1-800-222-1222) right away.

  • Directions

    • 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
    • adults and children 17 years of age and older:
      • fill to top of line in cap which is marked to indicate the correct dose (17 g)
      • stir and dissolve in any 4 to 8 ounce of beverage (cold, hot, or room temperature) then drink 
      • use once a day
      • use no more than 7 days
    • children 16 years of age or under: ask a doctor
  • Other information

    • store at 20-25ºC (68-77ºF)
  • Inactive ingredient

    none

  • Principal Display Panel

    *Compare to the active ingredient in MIRALAX®

    EasyLAX

    ORIGINAL STRENGTH

    Polyethylene Glycol 3350

    Powder for Oral Solution

    Osmotic Laxative

    • Relieves Occasional Constipation  (irregularity)
    • Softens stool
    • Dissolves in any beverage
    • Sugar Free 
    • Unflavored, grit-free powder

    FL OZ (mL)

    TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

    Polyethylene glycol 3350 increases frequency of bowel movements and softens the stool

    *This product is not manufactured or distributed by Bayer HealthCare LLC, distributor of MIRALAX®.

    Distributed by: Marc Glassman, Inc.

    West 130th Street, Cleveland, OH 44130

  • Package Label

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

    Marc's EasyLAX Original Strength

  • INGREDIENTS AND APPEARANCE
    EASYLAX 
    polyethylene glycol powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68998-465
    Route of AdministrationTOPICAL
    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
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68998-465-83238 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/31/201612/30/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09107708/31/201612/30/2021
    Labeler - Marc Glassman, Inc. (094487477)
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