Label: CETIRIZINE HYDROCHLORIDE (ALLERGY)- cetirizine hydrochloride tablet

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

Drug Label Information

Updated February 17, 2021

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  • SPL UNCLASSIFIED SECTION


    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

    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)
    • TAMPER EVIDENT: DO NOT USE IF SEAL OVER BOTTLE OPENING IS BROKEN OR MISSING.
  • Inactive ingredients

    colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide.

  • Questions?

    call 1-855-274-4122
    Keep the carton. It contains important information.

    distributed by:
    AllWell Health, Inc,
    Princeton, NJ 08540
    getallwell.com

    Made in India

    Code: TS/DRUGS/19/1993

  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (30's Tablet Container Label)

    NDC 80539-002-09
    allwell™
    allergy relief
    cetirizine hydrochloride
    tablets USP 10 mg
    original prescription strength
    antihistamine

    30 tablets, 10 mg each

    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 5 mg (30's Tablet Container Carton Label)

  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -10 mg (30's Container Carton Label)

    NDC 80539-002-09
    allwell™
    allergy
    relief
    cetirizine hydrochloride
    tablets USP 10 mg
    original prescription strength
    antihistamine

    indoor & outdoor allergies

    24 hour relief of :

        –    sneezing            –    itchy, watery eyes

        –    runny nose        –   itchy nose or throat 

    30 tablets
    10 mg each

    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -5 mg (10 x 10 Blister Carton Label)


  • INGREDIENTS AND APPEARANCE
    CETIRIZINE HYDROCHLORIDE (ALLERGY) 
    cetirizine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80539-002
    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
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorWHITE (White to Off-white) Scoreno score
    ShapeROUNDSize8mm
    FlavorImprint Code X;36
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80539-002-091 in 1 CARTON02/15/2021
    130 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09076002/15/2021
    Labeler - Allwell Health Inc (117644800)
    Registrant - Aurohealth LLC (078728447)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aurobindo Pharma Limited918917642ANALYSIS(80539-002) , MANUFACTURE(80539-002)
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