Label: CETIRIZINE HYDROCHLORIDE (ALLERGY)- cetirizine hydrochloride capsule

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated March 11, 2021

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  • SPL UNCLASSIFIED SECTION

    Cetirizine HCl Capsules 10 mg (Allergy)
    Drug Facts

  • Active ingredient (in each capsule)

    Cetirizine HCl 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 DOCTOR

    Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.

  • ASK DOCTOR/PHARMACIST

    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


    adults and children
    6 years and over
    		one 10 mg capsule once daily;
    do not take more than one 10 mg
    capsule 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 at 20°-25°C (68°-77°F)
    • avoid high humidity and excessive heat above 40°C (104°F)
    • protect from light
    • do not use if seal imprinted with SEALED for YOUR PROTECTION under the bottle cap is broken or missing.

  • Inactive ingredients

    black iron oxide, gelatin, glycerin, hypromellose, polyethylene glycol, propylene glycol, purified water, sodium hydroxide, sorbitol sorbitan solution

  • 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 
    Code: TS/DRUGS/16/2014

  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (40's Capsule Container Label)

    PrimaryHealth            NDC 58602-863-12
    ALLERGY
    Original
    Prescription Strength
    Cetirizine HCl Capsules
    10 mg
    Antihistamine
    INDOOR + OUTDOOR ALLERGIES

    40 LIQUID GELS*
    * LIQUID-FILLED CAPSULES
    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (12's Capsule Container Label)

  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -10 mg (40's Capsule Container Carton Label)

    NDC 58602-863-12
    PrimaryHealth
    COMPARE TO Zyrtec®
    active ingredient*
    Original Prescription Strength
     ALLERGY      

    Cetirizine HCl Capsules
    10 mg
    Antihistamine
    INDOOR +OUTDOOR  ALLERGIES

    24 HOUR
    RELIEF OF

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

    CZ10
    (Actual size)
    40 LIQUID GELS*
    * LIQUID-FILLED CAPSULES
    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -10 mg (12's Capsule Container Carton Label)

  • INGREDIENTS AND APPEARANCE
    CETIRIZINE HYDROCHLORIDE (ALLERGY) 
    cetirizine hydrochloride capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-863
    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
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    ColorYELLOW (Clear colourless to pale yellow viscous liquid) Scoreno score
    ShapeOVALSize13mm
    FlavorImprint Code CZ10
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58602-863-121 in 1 CARTON03/12/2021
    140 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20910703/12/2021
    Labeler - Aurohealth LLC (078728447)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aurobindo Pharma Limited650381903ANALYSIS(58602-863) , MANUFACTURE(58602-863)
    Establishment
    NameAddressID/FEIBusiness Operations
    APL HEALTHCARE LIMITED650844777ANALYSIS(58602-863) , MANUFACTURE(58602-863)
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