Label: ALLERGY RELIEF- cetirizine hydrochloride tablet, film coated

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

Drug Label Information

Updated December 8, 2023

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  • Drug Facts

  • Active Ingredient (in each tablet)

    Cetirizine HCl 10 mg

  • Purpose

    Antihistamine

  • Uses

    temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
    • runny nose • itchy, watery eyes • sneezing • 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 & children 6 years & overone 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 & overask a doctor
    children under 6 years of ageask a doctor
    consumers with liver or kidney diseaseask a doctor

  • Other information

    • store between 20–25°C (68–77°F)

  • Inactive ingredients

    Lactose, povidone, maize starch, magnesium stearate, purified water, titanium dioxide, hypromellose, macrogol

  • Questions or comments?

    1-888-333-9792

  • PRINCIPAL DISPLAY PANEL

    Cetirizine Label

    Cetirizine Carton

  • INGREDIENTS AND APPEARANCE
    ALLERGY RELIEF 
    cetirizine hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82501-1574
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24) CETIRIZINE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    POVIDONE (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeSQUARESize8mm
    FlavorImprint Code CTN10
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82501-1574-31 in 1 CARTON05/27/2022
    130 in 1 PACKAGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07782905/27/2022
    Labeler - Gobrands, Inc (057499049)
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