Label: CETIRIZINE HYDROCHLORIDE tablet

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

Drug Label Information

Updated January 19, 2023

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

  • Active ingredient

    (in each tablet)
    Cetirizine HCl 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

    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° to 25°C (68° to 77°F)
    ■ contains no ingredient made from a gluten-containing grain (Wheat, barley or rye)

  • Inactive ingredients

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

  • Questions?

    call 1-877-770-3183: Weekdays 9:00 AM to 4:30 PM EST.

  • PRINCIPAL DISPLAY PANEL

    90 count

  • INGREDIENTS AND APPEARANCE
    CETIRIZINE HYDROCHLORIDE 
    cetirizine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69848-006
    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)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    HYPROMELLOSES (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
    Colorwhite (White to off-white) Score2 pieces
    ShapeRECTANGLE (round-off rectangular shaped tablets) Size9mm
    FlavorImprint Code G;4
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69848-006-0990 in 1 BOTTLE; Type 0: Not a Combination Product06/30/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20927406/30/2021
    Labeler - Granules USA, Inc. (137098864)