Label: POLYETHYLENE GLYCOL powder, for solution

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated May 4, 2017

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  • SPL UNCLASSIFIED SECTION

    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 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
    • the bottle top is a measuring cap marked to contain 17 grams of powder when filled to the indicated line (white section in cap)
    • adults and children 17 years of age and older:
      • fill to top of white 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° 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 Ingredient

    none

  • Questions or comments?

    1-877-753-3935

    Made in India

    *Miralax® is a registered trademark of Bayer Consumer Care Holdings LLC

    Distributed by Liberty

    Procurement, Inc.650 Liberty

    Ave. Union, NJ 07083 USA

    Visit us at: www.facevalues.com

    Revised: 01/2017

  • SPL UNCLASSIFIED SECTION

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 63940-762-03

    Polyethylene Glycol 3350

    Powder for Solution

    OSMOTIC LAXATIVE

    Polyethylene Glycol 3350 powder for solution increases frequency of bowel movements and softens the stool.

    • Relieves Occasional Constipation (Irregularity)
    • Softens Stool
    • Dissolves in any beverage
    • Sugar Free

    TAMPER-EVIDENT: DO NOT USE IF PRINTED FOIL SEAL UNDER CAP IS MISSING, OPEN OR BROKEN

    7 Once-Daily Doses

    NET WT 4.15 OZ (119 g)

    peg-119g
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 63940-762-04

    Polyethylene Glycol 3350

    Powder for Solution

    OSMOTIC LAXATIVE

    Polyethylene Glycol 3350 powder for solution increases frequency of bowel movements and softens the stool.

    • Relieves Occasional Constipation (Irregularity)
    • Softens Stool
    • Dissolves in any beverage
    • Sugar Free

    TAMPER-EVIDENT: DO NOT USE IF PRINTED FOIL SEAL UNDER CAP IS MISSING, OPEN OR BROKEN

    14 Once-Daily Doses

    NET WT 8.3 OZ (238 g)

    peg-238g
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 63940-762-05

    Polyethylene Glycol 3350

    Powder for Solution

    OSMOTIC LAXATIVE

    Polyethylene Glycol 3350 powder for solution increases frequency of bowel movements and softens the stool.

    • Relieves Occasional Constipation (Irregularity)
    • Softens Stool
    • Dissolves in any beverage
    • Sugar Free

    TAMPER-EVIDENT: DO NOT USE IF PRINTED FOIL SEAL UNDER CAP IS MISSING, OPEN OR BROKEN

    30 Once-Daily Doses

    NET WT 17.9 OZ (510 g)

    peg-510g
  • INGREDIENTS AND APPEARANCE
    POLYETHYLENE GLYCOL 
    polyethylene glycol powder, for solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63940-762
    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
    ColorWHITE ((colorless upon dissolution)) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63940-762-03119 g in 1 BOTTLE; Type 0: Not a Combination Product08/24/2016
    2NDC:63940-762-04238 g in 1 BOTTLE; Type 0: Not a Combination Product08/24/2016
    3NDC:63940-762-05510 g in 1 BOTTLE; Type 0: Not a Combination Product08/24/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20392808/24/2016
    Labeler - Harmon Stores, Inc (804085293)
    Registrant - Strides Shasun Limited (918513263)
    Establishment
    NameAddressID/FEIBusiness Operations
    Strides Shasun Limited918513263ANALYSIS(63940-762) , MANUFACTURE(63940-762) , PACK(63940-762)
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