KIRKLAND SIGNATURE ALLER TEC ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET, FILM COATED [COSTCO WHOLESALE COMPANY]

KIRKLAND SIGNATURE ALLER TEC ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET, FILM COATED [COSTCO WHOLESALE COMPANY]
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NDC 63981-458-00, 63981-458-88
Set ID d4a688aa-02d4-4af6-9a91-ed31679cfaf8
Category HUMAN OTC DRUG LABEL
Packager Costco Wholesale Company
Generic Name
Product Class
Product Number
Application Number ANDA078336
  • Active ingredient (in each tablet)

    Cetirizine HCl 10 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

    adults and children 6 years and over

    one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms.

    adults 65 years and over

    ask a doctor

    children under 6 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 printed foil under cap is broken or missing
  • Inactive ingredients

    corn starch, FD&C blue no. 1 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, polydextrose, polyethylene glycol, povidone, titanium dioxide, triacetin

  • Questions or comments?

    1-800-719-9260

  • Principal Display Panel

    COMPARE TO ZYRTEC® active ingredient

    ALLERGY

    ALLER – TEC®

    Cetirizine Hydrochloride Tablets, 10 mg – Antihistamine

    Indoor & Outdoor Allergies

    24 Hour

    Relief of:

    Sneezing

    Runny Nose

    Itchy, Watery Eyes

    Itchy Throat or Nose

    Original Prescription Strength

    365 Tablets

    Actual Size

    ALLER TEC IMAGE 1
    ALLER TEC IMAGE 2
  • INGREDIENTS AND APPEARANCE
    KIRKLAND SIGNATURE ALLER TEC  ALLERGY
    cetirizine hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63981-458
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24) CETIRIZINE HYDROCHLORIDE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYDEXTROSE (UNII: VH2XOU12IE)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeOVALSize10mm
    FlavorImprint Code 4H2
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63981-458-881 in 1 PACKAGE10/15/2008
    1365 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:63981-458-005 in 1 CARTON03/01/2019
    21 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07833603/25/2008
    Labeler - Costco Wholesale Company (103391843)