Label: CETIRIZINE HYDROCHLORIDE tablet, film coated

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

Drug Label Information

Updated May 16, 2022

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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.

  • Active ingredient (in each tablet)

    Cetirizine Hydrochloride, 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 (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
  • Other information

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

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

  • Questions? 1-800-848-0462

    • Serious side effects associated with use of this product may be
      reported to this number.
  • 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 for:
    Mylan Pharmaceuticals Inc.
    Morgantown, WV 26505 U.S.A.

    Made in India

    Code No.: MH/DRUGS/25/NKD/89

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

    S-12769
    10/21

  • 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 for:
    Mylan Pharmaceuticals Inc.
    Morgantown, WV 26505 U.S.A.

    Made in India

    S-12721

    • 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 10 mg Carton Label
    Unit Dose Outer Carton
  • INGREDIENTS AND APPEARANCE
    CETIRIZINE HYDROCHLORIDE 
    cetirizine hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51079-597(NDC:0378-3637)
    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
    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
    ColorwhiteScoreno score
    ShapeROUNDSize8mm
    FlavorImprint Code M;C37
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51079-597-20100 in 1 BOX, UNIT-DOSE03/30/2012
    1NDC:51079-597-011 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07667703/30/2012
    Labeler - Mylan Institutional Inc. (039615992)
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