KIRKLAND SIGNATURE CHILDRENS ALLER TEC (CETIRIZINE HCL) SOLUTION [COSTCO WHOLESALE COMPANY]

KIRKLAND SIGNATURE CHILDRENS ALLER TEC (CETIRIZINE HCL) SOLUTION [COSTCO WHOLESALE COMPANY]
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NDC 63981-475-34, 63981-475-43
Set ID eb14a311-7918-4c4b-ae05-7606cfb8a4af
Category HUMAN OTC DRUG LABEL
Packager Costco Wholesale Company
Generic Name
Product Class
Product Number
Application Number ANDA204226
  • Active ingredient (in each 5 mL)

    Cetirizine HCl 5 mg

  • Purpose

    Antihistamine

  • Uses

    temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

    runny nose
    sneezing
    itchy, watery eyes
    itching of the nose or throat
  • Warnings

    Do not use

    if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine.

    Ask a doctor before use if you have

    liver or kidney disease. Your doctor should determine if you need a different dose.

    Ask a doctor or pharmacist before use if you are

    taking tranquilizers or sedatives.

    When using this product

    drowsiness may occur
    avoid alcoholic drinks
    alcohol, sedatives, and tranquilizers may increase drowsiness
    be careful when driving a motor vehicle or operating machinery

    Stop use and ask a doctor if

    an allergic reaction to this product occurs. Seek medical help right away.

    If pregnant or breast-feeding:

    if breast-feeding: not recommended
    if pregnant: 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

    use only with enclosed dosing cup
    find right dose on chart below
    mL = milliliter

    adults and children 6 years and over

    5 mL or 10 mL once daily depending upon severity of symptoms; do not take more than 10 mL in 24 hours.

    adults 65 years and over

    5 mL once daily; do not take more than 5 mL in 24 hours.

    children 2 to under 6 years of age

    2.5 mL once daily. If needed, dose can be increased to a maximum of 5 mL once daily or 2.5 mL every 12 hours. Do not give more than 5 mL in 24 hours.

    children under 2 years of age

    ask a doctor

    consumers with liver or kidney disease

    ask a doctor

    Other information

    store between 20° to 25°C (68° to 77°F)
    do not use if carton is opened, or if printed neckband is broken or missing
    see bottom panel for lot number and expiration date
  • Inactive Ingredients

    anhydrous citric acid, artificial grape flavor, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose

    Questions or comments?

    1-800-719-9260

  • Package/Label Principal Display Panel

    COMPARE TO CHILDREN’S ZYRTEC® active ingredient

    CHILDREN’S

    ALLER-TEC®

    Cetirizine Hydrochloride Oral Solution 1 mg/mL Antihistamine

    Indoor & Outdoor Allergies

    Allergy

    24 Hour Relief of:

    Itcy, Watery Eyes

    Itchy Throat or Nose

    Sneezing

    Runny Nose

    Sugare Free

    Dye Free

    Grape Flavor

    2 x 8 Fl oz bottles

    Total 16 Fl oz (1 pint) 480 mL

    2 Years & Older

    Children's Aller-Tec Carton Image 1

    Children's Aller-Tec Carton Image 2

  • INGREDIENTS AND APPEARANCE
    KIRKLAND SIGNATURE CHILDRENS ALLER TEC 
    cetirizine hcl solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63981-475
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24) CETIRIZINE HYDROCHLORIDE5 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63981-475-432 in 1 CARTON07/08/2016
    1NDC:63981-475-34240 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20422607/08/2016
    Labeler - Costco Wholesale Company (103391843)

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