Label: CETIRIZINE HCL- cetirizine tablet
CETIRIZINE HCL- cetirizine kit

  • NDC Code(s): 72657-128-03, 72657-128-04, 72657-128-08, 72657-128-14, view more
    72657-128-15, 72657-128-18, 72657-128-24, 72657-128-30, 72657-128-35, 72657-128-45, 72657-128-60, 72657-128-70, 72657-128-81, 72657-128-82, 72657-128-84, 72657-128-86, 72657-128-90, 72657-129-03, 72657-129-04, 72657-129-08, 72657-129-14, 72657-129-15, 72657-129-18, 72657-129-24, 72657-129-30, 72657-129-35, 72657-129-45, 72657-129-60, 72657-129-70, 72657-129-81, 72657-129-82, 72657-129-84, 72657-129-86, 72657-129-90, 72657-130-05, 72657-131-89
  • Packager: GLENMARK THERAPEUTICS INC., USA
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated June 17, 2024

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  • ACTIVE INGREDIENT

    Cetirizine HCl 5 mg

    Cetirizine HCl 10 mg

  • PURPOSE

    Antihistamine

  • INDICATIONS & USAGE

    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 an antihistamine containing hydroxyzine

    Ask a doctor before useif 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 (1-800-222-1222)

  • DOSAGE & ADMINISTRATION

    Cetirizine Hydrochloride Tablets, USP 5 mg

    adults and children 6 years and over

    1 tablet (5 mg) or 2 tablets (10) once daily depending upon severity of symptoms; do not take more than 2 tablets (10) in 24 hours.

    adults 65 years and over

    1 tablet (5 mg) once a day; do not take more than 1 tablet (5 mg) in 24 hours.

    children under 6 years of age

    ask a doctor

    consumers with liver or kidney disease

    ask a doctor

    Cetirizine Hydrochloride Tablets, USP 10 mg

    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 20°C to 25°C (68°F to 77°F)
    •
    do not use of imprinted foil inner seal on bottle is broken or missing.
    •
    FDA approved organic impurities test procedure differs from USP
  • INACTIVE INGREDIENT

    colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide

  • OTHER SAFETY INFORMATION

    Questions or comments?

    call toll-free weekdays 9 AM to 5 PM EST at 1 (888) 721-7115

    Manufactured by:

    Glenmark Pharmaceuticals Limited

    Pithampur, Madhya Pradesh 454775, India

    Distributed by:

    Glenmark Therapeutics Inc., USA

    Mahwah, NJ 07430

    Product of India

    February 2024

  • Principal Display Panel

    5mg365label
  • Principal Display Panel

    10mg365label
  • Principal Display Panel

    NDC 72657-130-89

    5 mg - 150 Tablets
    (contains one bottle of 60 Tablets
    and one bottle of 90 Tablets

    5mgkit
  • Principal Display Panel

    10mgkit
  • INGREDIENTS AND APPEARANCE
    CETIRIZINE HCL 
    cetirizine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72657-128
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24) CETIRIZINE HYDROCHLORIDE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE K30 (UNII: U725QWY32X)  
    SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeROUNDSize6mm
    FlavorImprint Code C;13
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72657-128-301 in 1 CARTON05/13/2024
    130 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:72657-128-451 in 1 CARTON05/13/2024
    245 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:72657-128-601 in 1 CARTON05/13/2024
    360 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:72657-128-701 in 1 CARTON05/13/2024
    470 in 1 BOTTLE; Type 0: Not a Combination Product
    5NDC:72657-128-901 in 1 CARTON05/13/2024
    590 in 1 BOTTLE; Type 0: Not a Combination Product
    6NDC:72657-128-081 in 1 CARTON05/13/2024
    6120 in 1 BOTTLE; Type 0: Not a Combination Product
    7NDC:72657-128-141 in 1 CARTON05/13/2024
    7140 in 1 BOTTLE; Type 0: Not a Combination Product
    8NDC:72657-128-151 in 1 CARTON05/13/2024
    8150 in 1 BOTTLE; Type 0: Not a Combination Product
    9NDC:72657-128-181 in 1 CARTON05/13/2024
    9180 in 1 BOTTLE; Type 0: Not a Combination Product
    10NDC:72657-128-241 in 1 CARTON05/13/2024
    10240 in 1 BOTTLE; Type 0: Not a Combination Product
    11NDC:72657-128-031 in 1 CARTON05/13/2024
    11300 in 1 BOTTLE; Type 0: Not a Combination Product
    12NDC:72657-128-351 in 1 CARTON05/13/2024
    12365 in 1 BOTTLE; Type 0: Not a Combination Product
    13NDC:72657-128-041 in 1 CARTON05/13/2024
    13400 in 1 BOTTLE; Type 0: Not a Combination Product
    14NDC:72657-128-812 in 1 CARTON05/13/2024
    1460 in 1 BOTTLE; Type 0: Not a Combination Product
    15NDC:72657-128-822 in 1 CARTON05/13/2024
    1570 in 1 BOTTLE; Type 0: Not a Combination Product
    16NDC:72657-128-842 in 1 CARTON05/13/2024
    1690 in 1 BOTTLE; Type 0: Not a Combination Product
    17NDC:72657-128-862 in 1 CARTON05/13/2024
    17120 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07842705/13/2024
    CETIRIZINE HCL 
    cetirizine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72657-129
    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
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE K30 (UNII: U725QWY32X)  
    SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeROUNDSize8mm
    FlavorImprint Code C;17
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72657-129-301 in 1 CARTON05/13/2024
    130 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:72657-129-451 in 1 CARTON05/13/2024
    245 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:72657-129-601 in 1 CARTON05/13/2024
    360 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:72657-129-701 in 1 CARTON05/13/2024
    470 in 1 BOTTLE; Type 0: Not a Combination Product
    5NDC:72657-129-901 in 1 CARTON05/13/2024
    590 in 1 BOTTLE; Type 0: Not a Combination Product
    6NDC:72657-129-081 in 1 CARTON05/13/2024
    6120 in 1 BOTTLE; Type 0: Not a Combination Product
    7NDC:72657-129-141 in 1 CARTON05/13/2024
    7140 in 1 BOTTLE; Type 0: Not a Combination Product
    8NDC:72657-129-151 in 1 CARTON05/13/2024
    8150 in 1 BOTTLE; Type 0: Not a Combination Product
    9NDC:72657-129-181 in 1 CARTON05/13/2024
    9180 in 1 BOTTLE; Type 0: Not a Combination Product
    10NDC:72657-129-241 in 1 CARTON05/13/2024
    10240 in 1 BOTTLE; Type 0: Not a Combination Product
    11NDC:72657-129-031 in 1 CARTON05/13/2024
    11300 in 1 BOTTLE; Type 0: Not a Combination Product
    12NDC:72657-129-351 in 1 CARTON05/13/2024
    12365 in 1 BOTTLE; Type 0: Not a Combination Product
    13NDC:72657-129-041 in 1 CARTON05/13/2024
    13400 in 1 BOTTLE; Type 0: Not a Combination Product
    14NDC:72657-129-812 in 1 CARTON05/13/2024
    1460 in 1 BOTTLE; Type 0: Not a Combination Product
    15NDC:72657-129-822 in 1 CARTON05/13/2024
    1570 in 1 BOTTLE; Type 0: Not a Combination Product
    16NDC:72657-129-842 in 1 CARTON05/13/2024
    1690 in 1 BOTTLE; Type 0: Not a Combination Product
    17NDC:72657-129-862 in 1 CARTON05/13/2024
    17120 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07842705/13/2024
    CETIRIZINE HCL 
    cetirizine kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72657-130
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72657-130-051 in 1 PACKAGE; Type 0: Not a Combination Product05/13/2024
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE 60 
    Part 21 BOTTLE 90 
    Part 1 of 2
    CETIRIZINE HCL 
    cetirizine tablet
    Product Information
    Item Code (Source)NDC:72657-128
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24) CETIRIZINE HYDROCHLORIDE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE K30 (UNII: U725QWY32X)  
    SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeROUNDSize6mm
    FlavorImprint Code C;13
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    11 in 1 CARTON
    160 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07842705/13/2024
    Part 2 of 2
    CETIRIZINE HCL 
    cetirizine tablet
    Product Information
    Item Code (Source)NDC:72657-128
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24) CETIRIZINE HYDROCHLORIDE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE K30 (UNII: U725QWY32X)  
    SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeROUNDSize6mm
    FlavorImprint Code C;13
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    11 in 1 CARTON
    190 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07842705/13/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07842705/13/2024
    CETIRIZINE HCL 
    cetirizine kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72657-131
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72657-131-891 in 1 PACKAGE; Type 0: Not a Combination Product05/13/2024
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE 60 
    Part 21 BOTTLE 90 
    Part 1 of 2
    CETIRIZINE HCL 
    cetirizine tablet
    Product Information
    Item Code (Source)NDC:72657-129
    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
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE K30 (UNII: U725QWY32X)  
    SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeROUNDSize8mm
    FlavorImprint Code C;17
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    11 in 1 CARTON
    160 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07842705/13/2024
    Part 2 of 2
    CETIRIZINE HCL 
    cetirizine tablet
    Product Information
    Item Code (Source)NDC:72657-129
    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
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE K30 (UNII: U725QWY32X)  
    SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeROUNDSize8mm
    FlavorImprint Code C;17
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    11 in 1 CARTON
    190 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07842705/13/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07842705/13/2024
    Labeler - GLENMARK THERAPEUTICS INC., USA (969085666)
    Establishment
    NameAddressID/FEIBusiness Operations
    Glenmark Pharmaceuticals Limited862603186ANALYSIS(72657-128, 72657-129, 72657-130, 72657-131) , MANUFACTURE(72657-128, 72657-129, 72657-130, 72657-131)
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