Label: CETIRIZINE HYDROCHLORIDE tablet, orally disintegrating

  • NDC Code(s): 58602-838-14, 58602-838-19, 58602-838-74, 58602-838-75, view more
    58602-838-76
  • Packager: Aurohealth LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated January 28, 2025

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  • 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 blister unit is torn 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:
    AUROHEALTH LLC
    279 Princeton-Hightstown Road
    East Windsor, NJ 08520

    Made in India


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

    AUROHEALTH
    NDC 58602-838-75
    *Compare to the active
    ingredient of Zyrtec® Allergy

    Original Prescription Strength
    Cetirizine Hydrochloride
    Orally Disintegrating Tablets, USP 10 mg
    Antihistamine

    Allergy
    DISSOLVE TABS
    Indoor & Outdoor Allergies
    24 Hour     Relief of:        Sneezing
    Runny Nose               Itchy, Watery        Itchy Throat
                                             Eyes                   or Nose

    Dye-Free

    Melts in your mouth
    Orange Flavor

    Actual Size

    12 Orally
    Disintegrating
    Tablets
    10 mg each

    figure

  • INGREDIENTS AND APPEARANCE
    CETIRIZINE HYDROCHLORIDE 
    cetirizine hydrochloride tablet, orally disintegrating
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-838
    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:58602-838-752 in 1 CARTON09/11/2020
    1NDC:58602-838-746 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:58602-838-764 in 1 CARTON09/11/2020
    2NDC:58602-838-746 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:58602-838-1411 in 1 CARTON09/11/2020
    3NDC:58602-838-746 in 1 BLISTER PACK; Type 0: Not a Combination Product
    4NDC:58602-838-1920 in 1 CARTON01/28/2025
    4NDC:58602-838-746 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 - Aurohealth LLC (078728447)
    Establishment
    NameAddressID/FEIBusiness Operations
    APL HEALTHCARE LIMITED650918514ANALYSIS(58602-838) , MANUFACTURE(58602-838)
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