Label: SMOOTH LAX- polyethylene glycol powder

  • NDC Code(s): 0363-0465-17, 0363-0465-26, 0363-0465-41, 0363-0465-83
  • Packager: Walgreens
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated November 10, 2015

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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

  • Questions or comments?

     Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

  • Principal Display Panel

    Smooth LAX®

    Polyethylene Glycol 3350

    Powder for Oral Solution,

    Osmotic Laxative

    • Relieves occasional constipation / irregularity
    • Softens stool
    • Unflavored powder
    • Grit free

    FL OZ (mL)

    Compare to MiraLAX® active ingredient≠≠

    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: WALGREEN CO.

    200 WILMOT RD., DEERFIELD, IL 60015

    walgreens.com

  • Package Label

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

    Well at Walgreens Smooth LAX

  • INGREDIENTS AND APPEARANCE
    SMOOTH LAX 
    polyethylene glycol powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0465
    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:0363-0465-17510 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:0363-0465-26765 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    3NDC:0363-0465-41119 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    4NDC:0363-0465-83238 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09107708/31/2015
    Labeler - Walgreens (008965063)
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