Label: CETIRIZINE HYDROCHLORIDE (ALLERGY)- cetirizine hydrochloride capsule

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

Drug Label Information

Updated August 16, 2022

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  • SPL UNCLASSIFIED SECTION

    Cetirizine HCl Capsules 10 mg (Allergy)
    Drug Facts

  • Active ingredient (in each capsule)

    Cetirizine HCI 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

    gelatin, glycerin, polyethylene 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 (65's Capsule Container Label)

    Healthy LivingTM

    Allergy                         Original Prescription Strength

    CETIRIZINE HCl
    Capsules 10 mg
    Antihistamine
    Indoor + Outdoor Allergies

    READ AND KEEP THE OUTER PACKAGE FOR            65 LIQUID GELS*
    COMPLETE WORNINGS AND INFORMATION          *liquid-filled capsules  
    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (25's Capsule Container Label)
                              
                                                                                                                                                  


  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -10 mg (65's Capsule Container Carton Label)

    Healthy LivingTM

    Allergy                       Original Prescription Strength

    CETIRIZINE HCl
    Capsules 10 mg
    Antihistamine
    Indoor + Outdoor Allergies                            *Compare
                                                                         to the Active
                                                                         Ingredient in                  CZ10
                                                                            Zyrtec®                             (Actual Size)     
     
    24 Hour Relief of: • Sneezing • Runny Nose                      65 Liquid Gels*
    • Itchy, Watery Eyes • Itchy Throat or Nose                     *liquid-filled capsules
    figure

  • INGREDIENTS AND APPEARANCE
    CETIRIZINE HYDROCHLORIDE (ALLERGY) 
    cetirizine hydrochloride capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-716
    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
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    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:58602-716-161 in 1 CARTON08/16/2022
    165 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20910708/16/2022
    Labeler - Aurohealth LLC (078728447)
    Establishment
    NameAddressID/FEIBusiness Operations
    APL HEALTHCARE LIMITED650844777ANALYSIS(58602-716) , MANUFACTURE(58602-716)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aurobindo Pharma Limited650381903ANALYSIS(58602-716) , MANUFACTURE(58602-716)
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