Label: ZYRTEC HIVES- cetirizine hydrochloride tablet, film coated

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated June 16, 2025

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each tablet)

    Cetirizine HCl 10 mg

  • Purpose

    Antihistamine

  • Uses

    reduces hives and relieves itching due to hives (urticaria). This product will not prevent hives or an allergic skin reaction from occurring.

  • Warnings

    Severe Allergy Warning

    Severe Allergy Warning: Get emergency help immediately if you have hives along with any of the following symptoms:

    • trouble swallowing
    • dizziness or loss of consciousness
    • swelling of tongue
    • swelling in or around mouth
    • trouble speaking
    • drooling
    • wheezing or problems breathing

    These symptoms may be signs of anaphylactic shock.
    This condition can be life threatening if not treated by a health professional immediately. Symptoms of anaphylactic shock may occur when hives first appear or up to a few hours later.

    Not a Substitute for Epinephrine. If your doctor has prescribed an epinephrine injector for "anaphylaxis" or severe allergy symptoms that could occur with your hives, never use this product as a substitute for the epinephrine injector. If you have been prescribed an epinephrine injector, you should carry it with you at all times.

    Do not use

    • to prevent hives from any known cause such as:

    -foods

    -insect stings

    -medicines

    -latex or rubber gloves

    because this product will not stop hives from occurring. Avoiding the cause of your hives is the only way to prevent them. Hives can sometimes be serious. If you do not know the cause of your hives, see your doctor for a medical exam. Your doctor may be able to help you find a cause.

    • 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.
    • hives that are an unusual color, look bruised or blistered
    • hives that do not itch

    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.
    • symptoms do not improve after 3 days of treatment
    • the hives have lasted more than 6 weeks

    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 overask a doctor
    children under 6 years
    of age
    ask a doctor
    consumers with liver or
    kidney disease
    ask a doctor

  • Other information

    Other information

    • store between 20° to 25°C (68° to 77°F)
    • do not use if foil inner seal imprinted with “Sealed For Your Safety” 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

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

  • PRINCIPAL DISPLAY PANEL

    Original Prescription Strength

    NDC 50580-116-30

    ZYRTEC ® HIVES
    Cetirizine HCl tablets
    10mg/antihistamine

    Hives Relief

    24 Hour relief

    Reduces Hives

    Reduces Itching Due to Hives

    30 Tablets 10 mg each

    Actual Size

    30 TABLETS

    zyrtec-1.jpg

  • INGREDIENTS AND APPEARANCE
    ZYRTEC HIVES 
    cetirizine hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50580-116
    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
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorwhiteScore2 pieces
    ShapeRECTANGLESize9mm
    FlavorImprint Code ZYRTEC;10mg
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50580-116-301 in 1 CARTON06/02/2025
    130 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01983506/02/2025
    Labeler - Kenvue Brands LLC (118772437)