Label: ZYRTEC ALLERGY- cetirizine hydrochloride tablet, film coated

  • NDC Code(s): 50580-754-15, 50580-754-35
  • Packager: Kenvue Brands LLC
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated July 21, 2025

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each tablet)

    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

    adults and children
    6 years and over
    1 tablet (5 mg) or 2 tablets (10 mg) once daily depending upon severity
    of symptoms; do not take more than 2 tablets (10mg) in 24 hours.
    adults 65 years and over1 tablet (5 mg) once daily; do not take more than 1 tablet (5 mg) in 24 hours.
    children under 6 years of ageask 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 pouch is torn or damaged
    ■ 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

    NDC 50580-754-15

    ZYRTEC®

    ALLERGY

    Cetirizine HCl Tablets
    5mg/antihistamine


    Indoor &
    Outdoor
    Allergies
    5mg Strength Tablets

    24 Hour relief of

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


    15 Tablets
    5 mg each


    Take 1 to 2 tablets* once daily depending on the severity of your symptoms
    *Adults 65 and older take only one tablet per day

    Actual Size

    15 Tablets

    zyrtec-01

  • INGREDIENTS AND APPEARANCE
    ZYRTEC ALLERGY 
    cetirizine hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50580-754
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24) CETIRIZINE HYDROCHLORIDE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeRECTANGLESize8mm
    FlavorImprint Code Z;5MG
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50580-754-351 in 1 CARTON02/15/2025
    135 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:50580-754-1515 in 1 CARTON02/15/2025
    21 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01983502/15/2025
    Labeler - Kenvue Brands LLC (118772437)
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