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

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

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 10/09

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

  • Active ingredient (in each dose)

    Polyethylene Glycol 3350, 17 g (in each level scoop)

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  • Purpose

    Laxative

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  • Uses

    • 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 enclosed scoop is a measuring device designed to contain 17 grams of powder when filled to the top (level scoop)
    • adults and children 17 years of age and older:
    • fill scoop completely with product to obtain the correct dose (17 g). Level scoop with knife or flat object.
    • 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

    Compare to MiraLAX® or Dulcolax® Balance active ingredient

    Value Size

    Original Prescription Strength

    Smooth Lax™

    Polyethylene Glycol 3350

    Powder for Solution, Laxative

    This Package For Households Without Young Children

    Relieves Occasional Constipation

    Softens Stool

    Laxative

    # Once-Daily Doses

    Smooth Lax(tm) Label

    Smooth Lax(tm) Label

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  • INGREDIENTS AND APPEARANCE
    SMOOTH LAX  ORIGINAL PRESCRIPTION STRENGTH
    polyethylene glycol 3350 powder, for solution
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0363-0181
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    POLYETHYLENE GLYCOL 3350 (POLYETHYLENE GLYCOL 3350) POLYETHYLENE GLYCOL 3350 17 g  in 17 g
    Product Characteristics
    Color WHITE (or almost whtie) Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0363-0181-04 850 g in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA090685 10/08/2009
    Labeler - Walgreen Company (008965063)
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