Label: CHILDRENS ZYRTEC ALLERGY- cetirizine hydrochloride tablet, orally disintegrating

  • NDC Code(s): 50580-782-01, 50580-782-12, 50580-782-24
  • Packager: Johnson & Johnson Consumer Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated June 6, 2023

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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

    Tablet melts in mouth. Can be taken with or without water.

    adults and children 6 years and overone 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 ageask a doctor
    consumers with liver or kidney diseaseask a doctor
  • Other information

    • store between 20° to 25°C (68° to 77°F). Avoid high humidity.
    • do not use if blister unit is torn or broken
  • Inactive ingredients

    amino methacrylate copolymer, anhydrous citric acid, colloidal silicon dioxide, crospovidone, flavors, hydroxypropyl cellulose, magnesium stearate, mannitol, microcrystalline cellulose, sodium bicarbonate, sodium starch glycolate, sucralose

  • Questions?

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

  • PRINCIPAL DISPLAY PANEL

    Original Prescription Strength

    NDC 50580-782-12

    Children's
    ZyRTEC ® ALLERGY

    Cetirizine HCl

    orally disintegrating tablets
    10 mg/antihistamine

    Indoor + Outdoor
    Allergies

    Dissolve Tabs

    24
    hour

    Relief of

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

    6 yrs.
    & older
    10mg each

    Citrus Flavor

    Actual
    Size

    Melts In
    Your Mouth

    12 ORALLY DISINTEGRATING TABLETS

    Zyrtec-1

  • INGREDIENTS AND APPEARANCE
    CHILDRENS ZYRTEC ALLERGY 
    cetirizine hydrochloride tablet, orally disintegrating
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50580-782
    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
    DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER (UNII: 905HNO1SIH)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MANNITOL (UNII: 3OWL53L36A)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize11mm
    FlavorCITRUSImprint Code Z10
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50580-782-122 in 1 CARTON01/20/2014
    16 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:50580-782-244 in 1 CARTON01/20/2014
    26 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:50580-782-012 in 1 PACKAGE01/20/2014
    34 in 1 CARTON
    36 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02257801/20/2014
    Labeler - Johnson & Johnson Consumer Inc. (878046358)
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