Label: CETIRIZINE HYDROCHLORIDE (ALLERGY)- cetirizine hydrochloride tablet

  • NDC Code(s): 16714-799-01, 16714-799-02, 16714-799-03, 16714-799-04
  • Packager: NorthStar Rx LLC
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated October 29, 2022

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  • SPL UNCLASSIFIED SECTION

    Cetirizine Hydrochloride Tablets USP 10 mg (ALLERGY RELIEF)

     
    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 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 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 1-800-206-7821

     

    Manufactured for: Northstar Rx LLC

                               Memphis, TN 38141

    Manufactured by: Aurobindo Pharma Limited

                               Hyderabad-500 090, India

    Code: TS/DRUGS/19/1993

    Issued: 03/2018

  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (500's Tablets Container Label)

    NDC 16714-799-04
    Cetirizine Hydrochloride
    Tablets USP 10 mg
    Antihistamine
    ALLERGY RELIEF
    Original Prescription Strength
    Indoor & Outdoor Allergies
    24 Hour Relief of :

    • Sneezing          • Runny Nose

    • Itchy, Watery Eyes     • Itchy Throat or Nose

                                                              500 Tablets

                                                              10 mg each


    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (500's Tablets Container Label)

  • INGREDIENTS AND APPEARANCE
    CETIRIZINE HYDROCHLORIDE (ALLERGY) 
    cetirizine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:16714-799
    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:16714-799-0130 in 1 BOTTLE; Type 0: Not a Combination Product08/05/2015
    2NDC:16714-799-02100 in 1 BOTTLE; Type 0: Not a Combination Product08/05/2015
    3NDC:16714-799-03300 in 1 BOTTLE; Type 0: Not a Combination Product08/05/2015
    4NDC:16714-799-04500 in 1 BOTTLE; Type 0: Not a Combination Product08/05/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09076008/05/2015
    Labeler - NorthStar Rx LLC (830546433)
    Registrant - Aurohealth LLC (078728447)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aurobindo Pharma Limited918917642ANALYSIS(16714-799) , MANUFACTURE(16714-799)
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