Label: CETIRIZINE HYDROCHLORIDE tablet, film coated

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated April 26, 2019

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • 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 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.

  • 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° and 25°C (68° - 77°F)
    • USP Dissolution Test 3
  • Inactive ingredients

    Lactose monohydrate, microcrystalline cellulose, starch (corn), magnesium stearate, hypromellose, polydextrose, polyethylene glycol and titanium dioxide.

  • Questions or comments?

    call 1-800-706-5575, weekdays, 8:30am - 5:00pm Eastern Standard Time

    Manufactured by:Manufactured for:
    Apotex Inc.Apotex Corp.
    Toronto, OntarioWeston, Florida
    Canada M9L 1T933326
  • HOW SUPPLIED

    Product: 50090-3188

    NDC: 50090-3188-0 14 TABLET, FILM COATED in a BOTTLE

    NDC: 50090-3188-1 30 TABLET, FILM COATED in a BOTTLE, PLASTIC

    NDC: 50090-3188-3 90 TABLET, FILM COATED in a BOTTLE, PLASTIC

    NDC: 50090-3188-2 100 TABLET, FILM COATED in a BOTTLE, PLASTIC

  • Cetirizine Hydrochloride

    Label Image
  • INGREDIENTS AND APPEARANCE
    CETIRIZINE HYDROCHLORIDE 
    cetirizine hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50090-3188(NDC:60505-2633)
    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
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    POLYDEXTROSE (UNII: VH2XOU12IE)  
    POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeRECTANGLE (pillow-shaped) Size9mm
    FlavorImprint Code 10MG;APO
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50090-3188-014 in 1 BOTTLE; Type 0: Not a Combination Product10/23/2017
    2NDC:50090-3188-130 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/28/2014
    3NDC:50090-3188-390 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/28/2014
    4NDC:50090-3188-2100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/28/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07831712/27/2007
    Labeler - A-S Medication Solutions (830016429)
    Establishment
    NameAddressID/FEIBusiness Operations
    A-S Medication Solutions830016429RELABEL(50090-3188) , REPACK(50090-3188)
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