Label: CETIRIZINE HYDROCHLORIDE- cetirizine hydrochloride tablets tablet, film coated

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

Drug Label Information

Updated January 3, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each tablet)

    Cetirizine HCl, 10mg

  • 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

    Ask a doctor before use if you have

    Do not use if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistaminecontaining 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

    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

    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

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

  • Directions

    adults and children 6 years and 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 and overask a doctor
    children under 6 years of ageask a doctor
    consumers with liver or kidney diseaseask a doctor
  • Other information

    • store between 20° to 25°C (68° to 77°F)
  • Inactive ingredients

    hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, starch, titanium dioxide.

  • Questions?

    call 1-888-375-3784.

  • HOW SUPPLIED

    NDC: 71335-9612-1: 30 Tablets in a BOTTLE

    NDC: 71335-9612-2: 14 Tablets in a BOTTLE

    NDC: 71335-9612-3: 7 Tablets in a BOTTLE

    NDC: 71335-9612-4: 10 Tablets in a BOTTLE

    NDC: 71335-9612-5: 15 Tablets in a BOTTLE

    NDC: 71335-9612-6: 90 Tablets in a BOTTLE

    NDC: 71335-9612-7: 20 Tablets in a BOTTLE

    NDC: 71335-9612-8: 60 Tablets in a BOTTLE

    NDC: 71335-9612-9: 100 Tablets in a BOTTLE

  • PRINCIPAL DISPLAY PANEL

    Cetirizine Hcl 10mg Tablet

    Label
  • INGREDIENTS AND APPEARANCE
    CETIRIZINE HYDROCHLORIDE 
    cetirizine hydrochloride tablets tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71335-9612(NDC:43598-811)
    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 MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeOVALSize7mm
    FlavorImprint Code C
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71335-9612-130 in 1 BOTTLE; Type 0: Not a Combination Product01/03/2023
    2NDC:71335-9612-214 in 1 BOTTLE; Type 0: Not a Combination Product01/03/2023
    3NDC:71335-9612-37 in 1 BOTTLE; Type 0: Not a Combination Product01/03/2023
    4NDC:71335-9612-410 in 1 BOTTLE; Type 0: Not a Combination Product01/03/2023
    5NDC:71335-9612-515 in 1 BOTTLE; Type 0: Not a Combination Product01/03/2023
    6NDC:71335-9612-690 in 1 BOTTLE; Type 0: Not a Combination Product01/03/2023
    7NDC:71335-9612-720 in 1 BOTTLE; Type 0: Not a Combination Product01/03/2023
    8NDC:71335-9612-860 in 1 BOTTLE; Type 0: Not a Combination Product01/03/2023
    9NDC:71335-9612-9100 in 1 BOTTLE; Type 0: Not a Combination Product01/03/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07834312/17/2018
    Labeler - Bryant Ranch Prepack (171714327)
    Registrant - Bryant Ranch Prepack (171714327)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bryant Ranch Prepack171714327REPACK(71335-9612) , RELABEL(71335-9612)
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