Label: CETIRIZINE HYDROCHLORIDE- cetirizine hydrochloride tablet, chewable

  • NDC Code(s): 0781-5284-06, 0781-5284-64
  • Packager: Sandoz Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated June 2, 2014

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

  • Active ingredient

    (in each chewable tablet)

    Cetirizine HCl 10 mg

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  • Purpose

    Antihistamine

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  • 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.

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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 reactions 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.

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  • Directions

    may be taken with or without water

    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 over

    ask a doctor

    children under 6 years of age

    ask a doctor

    consumers with liver or kidney disease

    ask a doctor

    Other information

    Store between 20º to 25º C (68º to 77º F)
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  • Inactive ingredients

    acesulfame potassium, artificial flavors, benzyl alcohol, betadex, colloidal silicon dioxide, dl-alpha-tocopherol, ferric oxide red, ferric oxide yellow, lactose monohydrate, magnesium stearate, maltodextrin, microcrystalline cellulose, propylene glycol, talc and tutti frutti flavor

    Questions? 1-800-525-8747

    Manufactured in India by Sandoz Private Ltd.,

    for Sandoz Inc., Princeton, NJ 08540

    Rev.06/2014

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  • Principal Display Panel

    NDC 0781-5284-64

    Children's

    Cetirizine HCl Chewable Tablets

    10 mg

    antihistamine

    Tutti Frutti Flavored

    30 Tablets

    Do not use if individual blister unit is open or torn

    ALLERGY

    Indoor & Outdoor Allergies

    24 hour Relief of

    Sneezing
    Runny Nose
    Itchy, Watery Eyes
    Itchy Throat or Nose

    6 yrs. and older 10 mg each

    Certrizine HCl Chewable Tablets 10mg.JPG
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  • INGREDIENTS AND APPEARANCE
    CETIRIZINE HYDROCHLORIDE 
    cetirizine hydrochloride tablet, chewable
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0781-5284
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24) CETIRIZINE HYDROCHLORIDE 10 mg
    Inactive Ingredients
    Ingredient Name Strength
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    BETADEX (UNII: JV039JZZ3A)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    Color YELLOW (peach, mottled) Score no score
    Shape ROUND Size 9mm
    Flavor Imprint Code SZ;106
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0781-5284-64 30 in 1 CARTON
    1 NDC:0781-5284-06 1 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA078692 02/14/2008
    Labeler - Sandoz Inc (110342024)
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