Label: BERKLEY AND JENSEN CLEARLAX- polyethylene glycol 3350 powder, for solution

  • 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?

    1-800-934-1204

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  • Principal Display Panel

    Compare to the active ingredient in MiraLAX®

    CLEARLAX®

    POLYETHYLENE GLYCOL 3350

    POWDER FOR SOLUTION

    OSMOTIC LAXATIVE

    RELIEVES OCCASIONAL CONSTIPATION/IRREGULARITY

    SOFTENS STOOL

    GLUTEN FREE

    17.9 OUNCES NET WT (510g)

    30 ONCE-DAILY DOSES

    UNFLAVORED POWDER

    GRIT FREE

    Berkley and Jensen Clearlax Image 1
    Berkley and Jensen Clearlax Image 2
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  • INGREDIENTS AND APPEARANCE
    BERKLEY AND JENSEN CLEARLAX 
    polyethylene glycol 3350 powder, for solution
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:68391-306
    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:68391-306-03 2 in 1 PACKAGE
    1 510 g in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA090685 12/17/2009
    Labeler - BJWC (159082692)
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