Label: POLYETHYLENE GLYCOL 3350 powder, for solution

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated May 21, 2019

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  • SPL UNCLASSIFIED SECTION

    MARLEX PHARMACEUTICALS, INC

    ----------

    Polyethylene Glycol 3350 powder, for solution

    Drug Facts

  • Active ingredient (in each dose)

    Polyethylene Glycol 3350, 17 g (cap filled to 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

    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 or pharmacist before use if you are

    taking a prescription drug

    When using this product

    you may 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
    • the bottle top is a measuring cap marked to contain 17 grams of powder when filled to the indicated line (clear section in cap)
    • adults and children 17 years of age and older:
      ○ fill to top of clear section in cap which is marked to indicate the correct dose (17 g)
      ○ stir and dissolve in any 4 to 8 ounces 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° - 25°C (68° - 77°F)
    • tamper- evident: do not use if foil seal under cap, printed with “SEALED for YOUR PROTECTION” is missing, open or broken
  • Inactive ingredient

    none

  • Questions or comments?

    1-800-FDA-1088

    Manufactured for & Distributed by:

    Marlex Pharmaceuticals, Inc.

    New Castle, DE 19720

    Rev. 04/19IT

  • PRINCIPAL DISPLAY PANEL

    NDC 10135-0683-04
    Polyethylene Glycol
    3350
    Powder for Solution, Osmotic Laxative
    Net Wt 4.1 oz (119 g)
    7 Once-Daily Doses

    PRINCIPAL DISPLAY PANEL NDC 10135-0683-04 Polyethylene Glycol 3350 Powder for Solution, Osmotic Laxative Net Wt 4.1 oz (119 g) 7 Once-Daily Doses

  • PRINCIPAL DISPLAY PANEL

    NDC 10135-0683-08
    Polyethylene Glycol
    3350
    Powder for Solution, Osmotic Laxative
    Net Wt 8.3 oz (238 g)
    14 Once-Daily Doses

    PRINCIPAL DISPLAY PANEL NDC 10135-0683-08 Polyethylene Glycol 3350 Powder for Solution, Osmotic Laxative Net Wt 8.3 oz (238 g) 14 Once-Daily Doses

  • PRINCIPAL DISPLAY PANEL

    NDC 10135-0683-12
    Polyethylene Glycol
    3350
    Powder for Solution, Osmotic Laxative
    Net Wt 17.9 oz (510 g)
    30 Once-Daily Doses

    PRINCIPAL DISPLAY PANEL NDC 10135-0683-12 Polyethylene Glycol 3350 Powder for Solution, Osmotic Laxative Net Wt 17.9 oz (510 g) 30 Once-Daily Doses

  • INGREDIENTS AND APPEARANCE
    POLYETHYLENE GLYCOL 3350 
    polyethylene glycol 3350 powder, for solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10135-683
    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:10135-683-04119 g in 1 BOTTLE; Type 0: Not a Combination Product04/01/2019
    2NDC:10135-683-08238 g in 1 BOTTLE; Type 0: Not a Combination Product04/01/2019
    3NDC:10135-683-12510 g in 1 BOTTLE; Type 0: Not a Combination Product04/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20207104/01/2019
    Labeler - Marlex Pharmaceuticals Inc (782540215)
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