Label: CETIRIZINE HYDROCHLORIDE TABLETS, 5 MG- cetirizine hydrochloride tablet
CETIRIZINE HYDROCHLORIDE TABLETS, 10 MG- cetirizine hydrochloride tablet

  • NDC Code(s): 25000-219-03, 25000-219-08, 25000-219-14, 25000-220-03, view more
    25000-220-08, 25000-220-14, 25000-220-78, 25000-220-81
  • Packager: MARKSANS PHARMA LIMITED
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated August 23, 2023

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  • Active ingredient (in each tablet)

    For 5 mg:

    Cetirizine HCl USP 5 mg


    For 10 mg:

    Cetirizine HCl 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. (1-800-222-1222)

  • Directions

    For 5 mg:


    adults and children 6 years and over1 tablet (5 mg) or 2 tablets (10 mg) once daily depending upon severity of symptoms; do not take more than 2 tablets (10 mg) in 24 hours
    adults 65 years and over1 tablet (5 mg) once daily; do not take more than 1 tablet (5 mg) in 24 hours.
    children under 6 years of ageask a doctor 
    consumers with liver or kidney diseaseask a doctor  

     

    For 10 mg:


    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)
    •do not use if foil seal under cap is broken or missing

  • Inactive ingredients

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


    Questions?
    Call at 1-877-376-4271

  • PRINCIPAL DISPLAY PANEL

    NDC 25000-219-03
    Cetirizine Hydrochloride Tablets USP, 5 mg
    30s count bottle label


    cetirizine-hcl-5-mg-30ct-bottle


    NDC 25000-219-03
    Cetirizine Hydrochloride Tablets USP, 5 mg
    30s count carton label


    cetirizine-hcl-5-mg-30ct-ifc

        
    NDC 25000-219-08
    Cetirizine Hydrochloride Tablets USP, 5 mg
    100s count bottle label


    cetirizine-hcl-5-mg-100ct-bottle


    NDC 25000-219-08
    Cetirizine Hydrochloride Tablets USP, 5 mg
    100s count carton label


    cetirizine-hcl-5-mg-100ct-ifc


    NDC 25000-219-14 
    Cetirizine Hydrochloride Tablets USP, 5 mg
    1000s count bottle label  


    cetirizine-hcl-5-mg-1000ct-bottle


    NDC 25000-220-03
    Cetirizine Hydrochloride Tablets USP, 10 mg

    30s count bottle label

    10mg-30sbottle

     


    NDC 25000-220-03
    Cetirizine Hydrochloride Tablets USP, 10 mg

    30s count carton label


    cetirizine-hcl-10-mg-30s-ifc


    NDC 25000-220-08
    Cetirizine Hydrochloride Tablets USP, 10 mg
    100s count bottle label

    10mg-100sbottle

     


    NDC 25000-220-08
    Cetirizine Hydrochloride Tablets USP, 10 mg

    100s count carton label


    cetirizine-hcl-10-mg-100ct-ifc


    NDC 25000-220-14
    Cetirizine Hydrochloride Tablets USP, 10 mg
    1000s count bottle label


    cetirizine-hcl-10-mg-1000s-label


    NDC 25000-220-78
    Cetirizine Hydrochloride Tablets USP, 10 mg

    7s count carton label


    cetirizine-hcl-10-mg-7s-ifc


    NDC 25000-220-81
    Cetirizine Hydrochloride Tablets USP, 10 mg

    14s count carton label


    cetirizine-hcl-10-mg-14s-ifc



  • INGREDIENTS AND APPEARANCE
    CETIRIZINE HYDROCHLORIDE TABLETS, 5 MG 
    cetirizine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:25000-219
    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
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    POVIDONE K30 (UNII: U725QWY32X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorWHITE (white to off white) Scoreno score
    ShapeRECTANGLE (Rounded-off rectangular shaped) Size7mm
    FlavorImprint Code J219
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:25000-219-031 in 1 CARTON01/13/2022
    130 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:25000-219-081 in 1 CARTON01/13/2022
    2100 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:25000-219-141000 in 1 BOTTLE; Type 0: Not a Combination Product01/13/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07893301/13/2022
    CETIRIZINE HYDROCHLORIDE TABLETS, 10 MG 
    cetirizine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:25000-220
    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
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    POVIDONE K30 (UNII: U725QWY32X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorWHITE (white to off white) Scoreno score
    ShapeRECTANGLE (Rounded-off rectangular shaped) Size9mm
    FlavorImprint Code J220
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:25000-220-031 in 1 CARTON01/13/2022
    130 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:25000-220-081 in 1 CARTON01/13/2022
    2100 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:25000-220-141000 in 1 BOTTLE; Type 0: Not a Combination Product01/13/2022
    4NDC:25000-220-781 in 1 CARTON04/17/2023
    47 in 1 BLISTER PACK; Type 0: Not a Combination Product
    5NDC:25000-220-811 in 1 CARTON07/21/2023
    514 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07893301/13/2022
    Labeler - MARKSANS PHARMA LIMITED (925822975)
    Establishment
    NameAddressID/FEIBusiness Operations
    MARKSANS PHARMA LIMITED925822975MANUFACTURE(25000-219, 25000-220)
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