Label: CAREALL CETIRIZINE HCL- cetirizine tablet

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

Drug Label Information

Updated February 19, 2020

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

  • ACTIVE INGREDIENT

    Cetirizine 10mg

  • PURPOSE

    Antihistamine

  • KEEP OUT OF REACH OF CHILDREN

    In case of accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) right away

  • INDICATIONS & USAGE

    Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

    runny nose, sneezing, itchy, watery eys, 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 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 sedatives or tranquilizers

    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.

  • DOSAGE & ADMINISTRATION

    Adult and children over 6 years old: One 10mg tablet once daily: no more than one 10mg tablet in 24 hours.  A 5mg 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

  • PREGNANCY

    If pregnant of breast-feeding:

    If breast-feeding: not recommended.

    If pregnant: ask a health professional before use.

  • INACTIVE INGREDIENT

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

  • OTHER SAFETY INFORMATION

    Store between 20-25 degrees celcius (68-77 degrees farhenheit).

    Do not use if imprinted seal under bottle cap is broken or missing

    You may report side effects 1-888-952-0050

  • PRINCIPAL DISPLAY PANEL

    Cetirizine Label

  • INGREDIENTS AND APPEARANCE
    CAREALL CETIRIZINE HCL 
    cetirizine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51824-076
    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)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    Product Characteristics
    Colorwhite (White to off white) Score2 pieces
    ShapeRECTANGLE (rounded off rectangular) Size9mm
    FlavorImprint Code G;4
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51824-076-0130 in 1 BOTTLE; Type 0: Not a Combination Product03/02/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20927403/02/2020
    Labeler - New World Imports (075372276)
    Registrant - New World Imports (075372276)