Label: CETIRIZINE HYDROCHLORIDE- cetirizine hydrochloride tablet, film coated

  • NDC Code(s): 0378-3635-01, 0378-3637-01, 0378-3637-05
  • Packager: Mylan Pharmaceuticals Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated February 9, 2015

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  • Active Ingredient (in each tablet)

    Cetirizine hydrochloride USP, 5 mg

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  • Purpose

    Antihistamine

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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.

    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

    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 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

    Anhydrous lactose, colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, sodium lauryl sulfate, titanium dioxide, and triacetin

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  • Questions?

    Call 1-877-446-3679 (1-877-4-INFO-RX)

    Mylan Pharmaceuticals Inc.
    Morgantown, WV 26505

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  • PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL - 5 mg Allergy

    NDC 0378-3635-01

    Cetirizine HCl
    Tablets, USP
    Allergy
    5 mg
    Antihistamine

    Indoor & Outdoor Allergies

    24 Hour Relief of

    runny nose
    sneezing
    itchy, watery eyes
    itching of the nose or throat

    RM-AR3635A5      100 Tablets

    Tamper Evident: do not use if foil seal
    under cap is missing, open or broken.

    Cetirizine HCl Tablets, USP 5 mg Carton Label
    Cetirizine HCl Tablets, USP 5 mg Carton Label - Back of Front Layer
    Cetirizine HCl Tablets, USP 5 mg Carton Label - Base Layer
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  • PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL - 10 mg Allergy

    NDC 0378-3637-01

    Cetirizine HCl
    Tablets, USP
    Allergy
    10 mg
    Antihistamine

    Indoor & Outdoor Allergies

    24 Hour Relief of

    runny nose
    sneezing
    itchy, watery eyes
    itching of the nose or throat

    RM-AR3637A5      100 Tablets     

    Tamper Evident: do not use if foil seal
    under cap is missing, open or broken.

    Active Ingredient (in each tablet)
    Cetirizine hydrochloride USP, 10 mg

    Directions

    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

    Cetirizine HCl Tablets, USP 10 mg Carton Label
    Cetirizine HCl Tablets, USP 10 mg Carton Label - Back of Front Layer
    Cetirizine HCl Tablets, USP 10 mg Carton Label - Base Layer
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  • INGREDIENTS AND APPEARANCE
    CETIRIZINE HYDROCHLORIDE 
    cetirizine hydrochloride tablet, film coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0378-3635
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24) CETIRIZINE HYDROCHLORIDE 5 mg
    Inactive Ingredients
    Ingredient Name Strength
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYDEXTROSE (UNII: VH2XOU12IE)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    Product Characteristics
    Color WHITE Score no score
    Shape ROUND Size 6mm
    Flavor Imprint Code M;C35
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0378-3635-01 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12/27/2007
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA076677 12/27/2007
    CETIRIZINE HYDROCHLORIDE 
    cetirizine hydrochloride tablet, film coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0378-3637
    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
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYDEXTROSE (UNII: VH2XOU12IE)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    Product Characteristics
    Color WHITE Score no score
    Shape ROUND Size 8mm
    Flavor Imprint Code M;C37
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0378-3637-01 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12/27/2007
    2 NDC:0378-3637-05 500 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12/27/2007
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA076677 12/27/2007
    Labeler - Mylan Pharmaceuticals Inc. (059295980)
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