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Zyrtec (McNeil Consumer Healthcare Division of McNeil-PPC, Inc.)

Available Formats

Dosage Form Package Information Links
TABLET, FILM COATED 2 BOTTLE, PLASTIC in 1 PACKAGE (50580-726-90) > 45 TABLET, FILM COATED in 1 BOTTLE, PLASTIC Label Information
TABLET, FILM COATED 50 BLISTER PACK in 1 CARTON (50580-726-03) > 1 TABLET, FILM COATED in 1 BLISTER PACK Label Information
TABLET, FILM COATED 1 BOTTLE, PLASTIC in 1 PACKAGE (50580-726-70) > 70 TABLET, FILM COATED in 1 BOTTLE, PLASTIC Label Information
TABLET, FILM COATED 1 BOTTLE, PLASTIC in 1 PACKAGE (50580-726-38) > 45 TABLET, FILM COATED in 1 BOTTLE, PLASTIC Label Information
TABLET, FILM COATED 1 BOTTLE, PLASTIC in 1 PACKAGE (50580-726-36) > 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC Label Information
TABLET, FILM COATED 3 BLISTER PACK in 1 CARTON (50580-726-13) > 1 TABLET, FILM COATED in 1 BLISTER PACK Label Information
TABLET, FILM COATED 14 BLISTER PACK in 1 PACKAGE (50580-726-32) > 1 TABLET, FILM COATED in 1 BLISTER PACK Label Information
TABLET, FILM COATED 75 TABLET, FILM COATED in 1 PACKAGE, COMBINATION (50580-726-66) Label Information
TABLET, FILM COATED 5 BLISTER PACK in 1 PACKAGE (50580-726-30) > 1 TABLET, FILM COATED in 1 BLISTER PACK Label Information
TABLET, FILM COATED 1 BOTTLE, PLASTIC in 1 PACKAGE (50580-726-50) > 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC Label Information
TABLET, FILM COATED 2 BOTTLE, PLASTIC in 1 PACKAGE (50580-726-51) > 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC Label Information

Complete Zyrtec Information

  • SPL UNCLASSIFIED SECTION

    Drug Facts


  • 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 clamshell is opened, or if foil inner seal imprinted with "ZYRTEC®" is broken or missing
    • meets USP Dissolution Test 2

  • Inactive ingredients

    colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide


  • Questions?

    call 1-800-343-7805 (toll-free) or 215-273-8755 (collect)


  • PRINCIPAL DISPLAY PANEL

    Original Prescription Strength

    NDC 50580-726-36

    ZYRTEC® ALLERGY
    Cetirizine HCl tablets
    10 mg /antihistamine

    Indoor & Outdoor Allergies

    24
    hour
    Relief of

    • Sneezing
    • Runny Nose
    • Itchy, Watery Eyes
    • Itchy Throat or Nose

    30 Tablets
    10 mg each

    (Actual Size)

    Principal Display Panel

  • INGREDIENTS AND APPEARANCE
    ZYRTEC ALLERGY 
    cetirizine hydrochloride tablet, film coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:50580-726
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Cetirizine Hydrochloride (UNII: 64O047KTOA) (Cetirizine - UNII:YO7261ME24) Cetirizine Hydrochloride 10 mg
    Inactive Ingredients
    Ingredient Name Strength
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Croscarmellose Sodium (UNII: M28OL1HH48)  
    Hypromellose, Unspecified (UNII: 3NXW29V3WO)  
    Lactose Monohydrate (UNII: EWQ57Q8I5X)  
    Magnesium Stearate (UNII: 70097M6I30)  
    Microcrystalline Cellulose (UNII: OP1R32D61U)  
    Polyethylene Glycol, Unspecified (UNII: 3WJQ0SDW1A)  
    Titanium Dioxide (UNII: 15FIX9V2JP)  
    Product Characteristics
    Color WHITE Score 2 pieces
    Shape RECTANGLE (rounded-off rectangular biconvex tablet) Size 9mm
    Flavor Imprint Code ZYRTEC;10;MG
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:50580-726-03 50 in 1 CARTON 01/01/2008
    1 1 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2 NDC:50580-726-13 3 in 1 CARTON 03/21/2009
    2 1 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3 NDC:50580-726-30 5 in 1 PACKAGE 01/01/2008
    3 1 in 1 BLISTER PACK; Type 0: Not a Combination Product
    4 NDC:50580-726-32 14 in 1 PACKAGE 01/01/2008
    4 1 in 1 BLISTER PACK; Type 0: Not a Combination Product
    5 NDC:50580-726-36 1 in 1 PACKAGE 01/01/2008
    5 30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    6 NDC:50580-726-50 1 in 1 PACKAGE 01/26/2010
    6 50 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    7 NDC:50580-726-51 2 in 1 PACKAGE 01/26/2010
    7 50 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    8 NDC:50580-726-38 1 in 1 PACKAGE 01/01/2008
    8 45 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    9 NDC:50580-726-70 1 in 1 PACKAGE 01/01/2008
    9 70 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    10 NDC:50580-726-90 2 in 1 PACKAGE 01/26/2010
    10 45 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    11 NDC:50580-726-66 75 in 1 PACKAGE, COMBINATION; Type 0: Not a Combination Product 01/01/2008
    12 NDC:50580-726-40 1 in 1 PACKAGE 01/20/2014
    12 40 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    13 NDC:50580-726-91 2500 in 1 CARTON 07/27/2018
    13 1 in 1 POUCH; Type 0: Not a Combination Product
    14 NDC:50580-726-92 50 in 1 TRAY 07/12/2018
    14 1 in 1 POUCH; Type 0: Not a Combination Product
    15 NDC:50580-726-93 3 in 1 CARTON 07/27/2018
    15 1 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA019835 01/01/2008
    Labeler - Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division (878046358)