Label: ZYRTEC- cetirizine hydrochloride tablet, chewable

  • NDC Code(s): 50580-753-24
  • Packager: Johnson & Johnson Consumer Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated August 8, 2024

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  • 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

    • may be taken with or without water
    • chew or crush tablets completely before swallowing

      adults and children 6 years and over

      Chew and swallow 1 tablet (10 mg) once daily; do not take more than 1 tablet (10 mg) 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 blister unit is torn or broken
  • Inactive ingredients

    betadex, corn starch, lactose monohydrate, magnesium stearate, mannitol, silicified microcrystalline cellulose, sucralose

  • Questions?

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

  • PRINCIPAL DISPLAY PANEL

    Original Prescription Strength NDC 50580-753-24

    ZYRTEC ®

    Cetirizine HCl Chewable tablets,
    10 mg /antihistamine

    ALLERGY

    Indoor + Outdoor

    Allergies

    Chewables

    DYE-Free

    24 HOUR

    Relief of

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

    Actual

    Size

    No Water

    Needed

    Chew or crush tablets completely

    before swallowing

    24 Chewable Tablets

    10 mg each

    zyrtec-01

  • INGREDIENTS AND APPEARANCE
    ZYRTEC 
    cetirizine hydrochloride tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50580-753
    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
    BETADEX (UNII: JV039JZZ3A)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MANNITOL (UNII: 3OWL53L36A)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize12mm
    FlavorImprint Code CET;10
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50580-753-244 in 1 CARTON06/20/2022
    16 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02162106/20/2022
    Labeler - Johnson & Johnson Consumer Inc. (878046358)
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