Label: CLEARLAX- polyethylene glycol 3350 powder, for solution

  • NDC Code(s): 56062-306-02, 56062-306-03
  • Packager: Publix Super Markets Inc
  • 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 01/13

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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  • 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 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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  • Principal Display Panel

    ORIGINAL PRESCRIPTION STRENGTH

    clearlax®

    POLYETHYLENE GLYCOL 3350

    POWDER FOR SOLUTION, OSMOTIC LAXATIVE

    relieves occasional constipation (irregularity)

    softens stool

    Compare to the active ingredient in MiraLAX®

    # ONCE-DAILY DOSES {Replace "#" with number daily doses}

    ClearLax Front Label Image
    ClearLaxBack Label Image
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  • INGREDIENTS AND APPEARANCE
    CLEARLAX 
    polyethylene glycol 3350 powder, for solution
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:56062-306
    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 Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:56062-306-03 510 g in 1 BOTTLE
    2 NDC:56062-306-02 238 g in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA090685 12/14/2009
    Labeler - Publix Super Markets Inc (006922009)
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