Label: CETIRIZINE HYDROCHLORIDE tablet

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated April 5, 2024

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  • ACTIVE INGREDIENT

    Active Ingredient (in each tablet)                                                

    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

    • drowsines may occur
    • avoid alcoholic drinks
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • be careful when driving a motor vehicle or operating machinary.
  • STOP USE

    Stop use and ask a doctor if an allergic reaction tothis 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 overAsk a doctor
    Children under 6 years of ageAsk a doctor
    Consumers with liver or kidney diseaseAsk a doctor

  • Other Information:

    store at 20° to 25°C (68° to 77°F)

    [See USP Controlled Room Temperature].

  • Inactive ingredients

    Hypromellose, lactose, magnesium stearate, maize starch, polyethylene glycol, povidone, titanium dioxide.

  • Questions?

    Call 1-844-874-7464

  • SPL UNCLASSIFIED SECTION

    Manufactured by:

    Unique Pharmaceutical Labs.

    (A Div. of J. B. Chemicals & Pharmaceuticals Ltd.),
    Mumbai 400 030, India


    Distributed by:

    Rising Pharma Holdings, Inc.
    East Brunswick, NJ 08816

    M. L. G/1430    Jul. 2020

    126406

  • HOW SUPPLIED

    NDC: 71335-0300-1: 30 Tablets in a BOTTLE

    NDC: 71335-0300-2: 14 Tablets in a BOTTLE

    NDC: 71335-0300-3: 7 Tablets in a BOTTLE

    NDC: 71335-0300-4: 10 Tablets in a BOTTLE

    NDC: 71335-0300-5: 15 Tablets in a BOTTLE

    NDC: 71335-0300-6: 90 Tablets in a BOTTLE

    NDC: 71335-0300-7: 20 Tablets in a BOTTLE

    NDC: 71335-0300-8: 60 Tablets in a BOTTLE

    NDC: 71335-0300-9: 100 Tablets in a BOTTLE

    Repackaged/Relabeled by:

    Bryant Ranch Prepack, Inc.

    Burbank, CA 91504

  • PRINCIPAL DISPLAY PANEL

    Cetirizine Hydrochloride 10 mg Tablet

    Label
  • INGREDIENTS AND APPEARANCE
    CETIRIZINE HYDROCHLORIDE 
    cetirizine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71335-0300(NDC:16571-402)
    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
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorWHITE (White) Scoreno score
    ShapeBULLET (Barrel Shaped) Size8mm
    FlavorImprint Code CTN;10
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71335-0300-130 in 1 BOTTLE; Type 0: Not a Combination Product02/16/2018
    2NDC:71335-0300-214 in 1 BOTTLE; Type 0: Not a Combination Product02/20/2018
    3NDC:71335-0300-37 in 1 BOTTLE; Type 0: Not a Combination Product02/09/2022
    4NDC:71335-0300-410 in 1 BOTTLE; Type 0: Not a Combination Product03/19/2019
    5NDC:71335-0300-515 in 1 BOTTLE; Type 0: Not a Combination Product02/09/2022
    6NDC:71335-0300-690 in 1 BOTTLE; Type 0: Not a Combination Product02/16/2018
    7NDC:71335-0300-720 in 1 BOTTLE; Type 0: Not a Combination Product03/07/2019
    8NDC:71335-0300-860 in 1 BOTTLE; Type 0: Not a Combination Product10/13/2021
    9NDC:71335-0300-9100 in 1 BOTTLE; Type 0: Not a Combination Product05/03/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07782910/01/2009
    Labeler - Bryant Ranch Prepack (171714327)
    Registrant - Bryant Ranch Prepack (171714327)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bryant Ranch Prepack171714327REPACK(71335-0300) , RELABEL(71335-0300)
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