Label: CETIRIZINE HYDROCHLORIDE- cetirizine hydrochloride tablet, film coated

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

Drug Label Information

Updated January 11, 2017

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  • SPL UNCLASSIFIED SECTION

    CETIRIZINE HCl
    10 mg TABLETS, USP

    Antihistamine

    Indoor & Outdoor Allergies

    TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN,
    BROKEN OR SHOW ANY SIGNS OF TAMPERING.

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  • Active ingredient (in each tablet)

    Cetirizine Hydrochloride, USP 10 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 (24 Hour Relief)

    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

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  • Other information

    Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]
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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? 1-800-848-0462

    Serious side effects associated with use of this product may be
    reported to this number.
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  • HOW SUPPLIED

    Cetirizine Hydrochloride Tablets, USP are available as follows:

    10 mg - White, film-coated, round, biconvex, beveled
    edge, unscored tablets debossed with M on one side of
    the tablet and C37 on the other side.

    NDC 51079-597-20 - Unit dose blister packages
    of 100 (10 cards of 10 tablets each).

    Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

    Manufactured by:
    Mylan Pharmaceuticals Inc.
    Morgantown, WV 26505 U.S.A.

    Distributed by:
    Mylan Institutional Inc.
    Rockford, IL 61103 U.S.A.

    S-9827 R8
    1/17

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  • PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL - 10 mg

    NDC 51079-597-20

    Cetirizine HCl
    Tablets, USP
    10 mg

    Antihistamine

    Indoor & Outdoor Allergies

    24 Hour Relief
    (See Uses section of enclosed leaflet)

    TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE
    TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.

    Manufactured by:
    Mylan Pharmaceuticals Inc.
    Morgantown, WV 26505 U.S.A.

    S-9828 R6

    This unit dose package is not child resistant.
    For institutional use only.
    Keep this and all drugs out of the reach of children.
    This container provides light-resistance.
    See window for lot number and expiration date.

    Distributed by:
    Mylan Institutional Inc.
    Rockford, IL 61103 U.S.A.

    Cetirizine Hydrochloride Tablets, USP 10 mg Carton Label
    Outer Carton Label
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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:51079-597(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)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYDEXTROSE (UNII: VH2XOU12IE)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (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:51079-597-20 100 in 1 BOX, UNIT-DOSE 03/30/2012
    1 NDC:51079-597-01 1 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA076677 03/30/2012
    Labeler - Mylan Institutional Inc. (039615992)
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