Label: SMOOTH LAX- polyethylene glycol 3350 powder, for solution

  • NDC Code(s): 0363-0306-01, 0363-0306-02, 0363-0306-03, 0363-0306-04, view more
    0363-0306-09, 0363-0306-10
  • Packager: Walgreen Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated 01/15

If you are a consumer or patient please visit this version.

  • Active ingredient (in each dose)

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

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  • Purpose

    Osmotic Laxative

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  • Use

    relieves occasional constipation (irregularity)
    generally produces a bowel movement in 1 to 3 days
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  • 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 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 right away. (1-800-222-1222)

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  • 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
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  • Other information

    store at 20°-25°C (68°-77°F)
    tamper-evident: do not use if printed foil seal under cap is missing, open or broken
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  • Inactive ingredients

    none

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  • Questions or comments?

    1-800-719-9260

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  • Principal Display Panel

    Smooth LAX®

    Polyethylene Glycol 3350

    Powder for Solution, Osmotic Laxative

    Relieves occasional constipation / irregularity

    Softens stool

    Unflavored powder

    Grit free

    14 ONCE-DAILY DOSES

    NET WT 8.3 OZ (238 g)

    Compare to MiraLAX® active ingredient

    Walgreens Smooth Lax Image 1
    Walgreens Smooth Lax Image 2
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  • INGREDIENTS AND APPEARANCE
    SMOOTH LAX 
    polyethylene glycol 3350 powder, for solution
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-0306
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P) (POLYETHYLENE GLYCOL 3350 - UNII:G2M7P15E5P) POLYETHYLENE GLYCOL 3350 17 g  in 17 g
    Product Characteristics
    Color WHITE Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0363-0306-02 238 g in 1 BOTTLE
    2 NDC:0363-0306-03 510 g in 1 BOTTLE
    3 NDC:0363-0306-04 850 g in 1 BOTTLE
    4 NDC:0363-0306-09 765 g in 1 BOTTLE
    5 NDC:0363-0306-01 119 g in 1 BOTTLE
    6 NDC:0363-0306-10 612 g in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA090685 10/09/2009
    Labeler - Walgreen Company (008965063)
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