Label: CHILDRENS CETIRIZINE HYDROCHLORIDE- cetirizine hydrochloride tablet, orally disintegrating

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

Drug Label Information

Updated May 24, 2023

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

View All Sections
  • Drug Facts

    Active ingredient (in each tablet)

    Cetirizine hydrochloride USP 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 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 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). Avoid high humidity.
    • do not use if carton or blister unit is opened or broken 
  • Inactive ingredients

    betadex, citric acid anhydrous, colloidal silicon dioxide, crospovidone, dl-alpha-tocopherol, hydroxypropyl cellulose, magnesium stearate, maize maltodextrin, mannitol, microcrystalline cellulose, natural flavourings, sodium bicarbonate, sodium starch glycolate and sucralose.

    Questions or comments?
    call 1-855-274-4122 (Monday - Friday 8:30 AM to 5:00 PM EST)


    Distributed by: WALGREEN CO.
    200 WILMOT RD., DEERFIELD, IL 60015

    Made in India

    Code: AP/DRUGS/04/2016


  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -10 mg (24 Orally Disintegrating Tablets) Blister Carton

    ORIGINAL PRESCRIPTION STRENGTH                NDC 0363-4025-76

    walgreens
    Compare to the active ingredient
    in Children's Zyrtec®Allergy††

    children's Allergy Relief
     CETIRIZINE HYDROCHLORIDE ORALLY DISINTEGRATING TABLETS, USP 10 mg / ANTIHISTAMINE

    24 Hour     Dissolve Tabs        Indoor & Outdoor Allergies
    • 24-hour relief of sneezing; runny nose; itchy, watery eyes & itchy throat or nose

    • Melts In your mouth

    AGES 6 YEARS & OLDER

    ACTUAL SIZE                    Orange
                                                  flavor

    24 ORALLY DISINTEGRATING TABLETS
    10 mg Each


    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -10 mg (12 Orally Disintegrating Tablets) Blister Carton

  • INGREDIENTS AND APPEARANCE
    CHILDRENS CETIRIZINE HYDROCHLORIDE 
    cetirizine hydrochloride tablet, orally disintegrating
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-4025
    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)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSPOVIDONE (35 .MU.M) (UNII: 40UAA97IT9)  
    .ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)  
    HYDROXYPROPYL CELLULOSE (110000 WAMW) (UNII: 5Y0974F5PW)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MANNITOL (UNII: 3OWL53L36A)  
    MICROCRYSTALLINE CELLULOSE 101 (UNII: 7T9FYH5QMK)  
    MICROCRYSTALLINE CELLULOSE 102 (UNII: PNR0YF693Y)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeROUNDSize10mm
    FlavorORANGEImprint Code CE;10
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-4025-764 in 1 CARTON09/11/2020
    16 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21355709/11/2020
    Labeler - WALGREEN CO. (008965063)
    Registrant - Aurohealth LLC (078728447)
    Establishment
    NameAddressID/FEIBusiness Operations
    APL HEALTHCARE LIMITED650918514ANALYSIS(0363-4025) , MANUFACTURE(0363-4025)
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!