Label: SUNMARK 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 November 27, 2017

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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, 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)

  • 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
  • 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
  • Inactive ingredients

    none

  • Questions or comments?

    1-800-719-9260

  • Polyethylene Glycol 3350

    Label Image
  • INGREDIENTS AND APPEARANCE
    SUNMARK CLEARLAX 
    polyethylene glycol 3350 powder, for solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50090-1447(NDC:49348-893)
    Route of AdministrationORAL
    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
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50090-1447-0238 g in 1 BOTTLE; Type 0: Not a Combination Product11/28/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09068510/07/2009
    Labeler - A-S Medication Solutions (830016429)
    Establishment
    NameAddressID/FEIBusiness Operations
    A-S Medication Solutions830016429RELABEL(50090-1447)
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