KIRKLAND SIGNATURE LAXACLEAR ORIGINAL PRESCRIPTION STRENGTH (POLYETHYLENE GLYCOL 3350) POWDER, FOR SOLUTION [COSTCO WHOLESALE COMPANY]

KIRKLAND SIGNATURE LAXACLEAR ORIGINAL PRESCRIPTION STRENGTH (POLYETHYLENE GLYCOL 3350) POWDER, FOR SOLUTION [COSTCO WHOLESALE COMPANY]
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NDC 63981-306-03, 63981-306-04, 63981-306-07
Set ID f58fa5c0-8ab7-4427-aea0-d536b47acbb5
Category HUMAN OTC DRUG LABEL
Packager Costco Wholesale Company
Generic Name
Product Class
Product Number
Application Number ANDA090685
  • Active ingredient (in each dose)

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

  • Purpose

    Osmotic Laxative

  • Use

    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
    ensure that the powder is fully dissolved before drinking
    do not drink if there are any clumps
    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

  • Principal Display Panel

    COMPARE TO MIRALAX® active ingredient

    LAXACLEAR®

    Polyethylene Glycol 3350 Powder for Solution

    Osmotic Laxative

    Unflavored Powder – Grit Free

    Relieves Occasional Constipation/Irregularity

    Softens Stool

    50 Once-Daily Doses

    NET WT 29.9 OZ (850g)

    laxaclear image
  • INGREDIENTS AND APPEARANCE
    KIRKLAND SIGNATURE LAXACLEAR  ORIGINAL PRESCRIPTION STRENGTH
    polyethylene glycol 3350 powder, for solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63981-306
    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:63981-306-073 in 1 PACKAGE01/24/2011
    1510 g in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:63981-306-03510 g in 1 BOTTLE; Type 0: Not a Combination Product01/24/2011
    3NDC:63981-306-04850 g in 1 BOTTLE; Type 0: Not a Combination Product11/07/2009
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09068511/07/2009
    Labeler - Costco Wholesale Company (103391843)