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 March 21, 2023

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

View All Sections
  • 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)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!