Label: CETIRIZINE HYDROCHLORIDE - cetirizine hydrochloride tablet 

  • Label RSS
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated 04/13

If you are a consumer or patient please visit this version.

  • Active Ingredients

    Active Ingredients (in each tablet)                                                        PurposeCetirizine HCl 5 mg.....................................................................................Antihistimine

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  • 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
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  • 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.

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  • ASK DOCTOR

    Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.

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  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.

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  • 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.
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  • STOP USE

    Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

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  • If pregnant or breast-feeding:

    • if breast-feeding: not recommended
    • if pregnant: ask a health professional before use.
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  • Keep out of reach of children.

    In case of overdose, get medical help or contact Poison Control Center right away.

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  • Directions

    Adults and children 6
     years and over
    1 to 2 tablets once daily depending upon severity of symptoms; do not take more than 2 tablets in 24 hours.
    Adults 65 years and over 1 tablet1 tablet once a day; do not take more than 1 tablet in 24 hours.
    Children under 6 years of age Ask a doctor
    Consumers with liver or kidney disease Ask a doctor
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  • Other Information

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

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  • Inactive Ingredients

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

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  • Questions?

    Call 1-866-562-4597

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  • SPL UNCLASSIFIED SECTION

    Manufactured for Unique Pharmaceutical Laboratories (A Div. of J. B. Chemicals & Pharmaceuticals Ltd.), Mumbai, INDIA.

    Manufactured by Unique Pharmaceutical Laboratories (A Div. of J. B. Chemicals & Pharmaceuticals Ltd.), Mumbai, INDIA.

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  • PRINCIPAL DISPLAY PANEL

    Cetirizine 5mg Tablet

    Label
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  • INGREDIENTS AND APPEARANCE
    CETIRIZINE HYDROCHLORIDE 
    cetirizine hydrochloride tablet
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:63629-4914(NDC:16571-401)
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CETIRIZINE HYDROCHLORIDE (CETIRIZINE) CETIRIZINE HYDROCHLORIDE 5 mg
    Inactive Ingredients
    Ingredient Name Strength
    HYPROMELLOSES  
    LACTOSE  
    MAGNESIUM STEARATE  
    STARCH, CORN  
    POLYETHYLENE GLYCOLS  
    POVIDONES  
    TITANIUM DIOXIDE  
    Product Characteristics
    Color white (White) Score no score
    Shape BULLET (Barrel Shaped) Size 7mm
    Flavor Imprint Code CTN;5
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:63629-4914-1 30 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA077829 10/01/2009
    Labeler - Bryant Ranch Prepack (171714327)
    Registrant - Bryant Ranch Prepack (171714327)
    Establishment
    Name Address ID/FEI Business Operations
    Bryant Ranch Prepack 171714327 REPACK(63629-4914), RELABEL(63629-4914)
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