Label: CETIRIZINE HYDROCHLORIDE- cetirizine hydrochloride tablet, film coated

  • NDC Code(s): 55111-351-04, 55111-351-30, 55111-351-45, 55111-351-47, view more
    55111-351-51, 55111-351-60, 55111-351-74, 55111-351-90, 55111-699-04, 55111-699-15, 55111-699-19, 55111-699-30, 55111-699-31, 55111-699-45, 55111-699-47, 55111-699-51, 55111-699-52, 55111-699-60, 55111-699-73, 55111-699-74, 55111-699-90
  • Packager: Dr.Reddy's Laboratories Limited
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated September 30, 2011

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  • Active ingredient (in each tablet)

    Cetirizine HCl, 10mg

  • 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

    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

    adults and children 6 years and overone 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 overask a doctor
    children under 6 years of ageask a doctor
    consumers with liver or kidney diseaseask a doctor
  • Other information

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

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

  • Questions?

    call 1-888-375-3784.

  • PRINCIPAL DISPLAY PANEL

    Bottle label

    Bottle

  • PRINCIPAL DISPLAY PANEL

    Carton label

    Carton

        

        

  • INGREDIENTS AND APPEARANCE
    CETIRIZINE HYDROCHLORIDE 
    cetirizine hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55111-699
    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
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POVIDONE (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeOVALSize7mm
    FlavorImprint Code C
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55111-699-901 in 1 CARTON04/08/2008
    190 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:55111-699-451 in 1 CARTON04/08/2008
    245 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:55111-699-301 in 1 CARTON04/03/2008
    330 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:55111-699-511 in 1 CARTON07/22/2008
    475 in 1 BOTTLE; Type 0: Not a Combination Product
    5NDC:55111-699-041 in 1 CARTON04/11/2008
    5120 in 1 BOTTLE; Type 0: Not a Combination Product
    6NDC:55111-699-191 in 1 CARTON01/15/2008
    6175 in 1 BOTTLE; Type 0: Not a Combination Product
    7NDC:55111-699-472 in 1 CARTON04/03/2008
    7175 in 1 BOTTLE; Type 0: Not a Combination Product
    8NDC:55111-699-601 in 1 CARTON04/07/2008
    860 in 1 BOTTLE; Type 0: Not a Combination Product
    9NDC:55111-699-731 in 1 CARTON10/06/2010
    9365 in 1 BOTTLE; Type 0: Not a Combination Product
    10NDC:55111-699-521 in 1 CARTON10/06/2010
    1014 in 1 BOTTLE; Type 0: Not a Combination Product
    11NDC:55111-699-742 in 1 CARTON04/04/2008
    117 in 1 BLISTER PACK; Type 0: Not a Combination Product
    12NDC:55111-699-311 in 1 CARTON09/27/2016
    12300 in 1 BOTTLE; Type 0: Not a Combination Product
    13NDC:55111-699-151 in 1 CARTON04/04/2008
    1314 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07834301/15/2008
    CETIRIZINE HYDROCHLORIDE 
    cetirizine hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55111-351
    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
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POVIDONE (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeROUNDSize6mm
    FlavorImprint Code RDY;351
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55111-351-301 in 1 CARTON01/15/2008
    130 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:55111-351-451 in 1 CARTON01/15/2008
    245 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:55111-351-601 in 1 CARTON01/15/2008
    360 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:55111-351-901 in 1 CARTON01/15/2008
    490 in 1 BOTTLE; Type 0: Not a Combination Product
    5NDC:55111-351-041 in 1 CARTON01/15/2008
    5120 in 1 BOTTLE; Type 0: Not a Combination Product
    6NDC:55111-351-472 in 1 CARTON01/15/2008
    6175 in 1 BOTTLE; Type 0: Not a Combination Product
    7NDC:55111-351-511 in 1 CARTON01/15/2008
    775 in 1 BOTTLE; Type 0: Not a Combination Product
    8NDC:55111-351-742 in 1 CARTON01/15/2008
    87 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07834301/15/2008
    Labeler - Dr.Reddy's Laboratories Limited (650562841)
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