Label: CETIRIZINE HYDROCHLORIDE 10 MG- cetirizine hydrochloride tablet

  • NDC Code(s): 66424-564-01, 66424-564-05
  • Packager: SDA Laboratories, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated April 27, 2021

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT (IN EACH TABLET)

    CETIRIZINE HYDROCHLORIDE 10 MG

  • PURPOSE

    ANTIHISTAMINE

  • USE

    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

    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

    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
    disease
    ask a doctor

  • OTHER INFORMATION

    • store between 20º to 25ºC (68º and 77º F)
  • INACTIVE INGREDIENTS

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

  • QUESTIONS?

    call toll free 1-800-687-0176
    Mon – Fri 8 am to 5 pm

  • PRINCIPAL DISPLAY PANEL

    01b LBL_Cetirizine HCl Tablets_10mg_500ct_PDP

    01b LBL_Cetirizine HCl Tablets_10mg_100ct_PDP

    01b LBL_Cetirizine HCl Tablets_10mg_500ct_DF1

    01b LBL_Cetirizine HCl Tablets_10mg_500ct_DF2

  • INGREDIENTS AND APPEARANCE
    CETIRIZINE HYDROCHLORIDE  10 MG
    cetirizine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66424-564
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24) CETIRIZINE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorwhiteScore2 pieces
    ShapeRECTANGLE (ROUNDED-OFF RECTANGLE) Size10mm
    FlavorImprint Code G4
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66424-564-05500 in 1 BOTTLE; Type 0: Not a Combination Product04/27/2021
    2NDC:66424-564-01100 in 1 BOTTLE; Type 0: Not a Combination Product04/27/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20927404/27/2021
    Labeler - SDA Laboratories, Inc. (948067889)