Label: ALLERGY- cetirizine hydrochloride tablet, film coated

  • NDC Code(s): 41226-692-14, 41226-692-65
  • Packager: Kroger Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated January 7, 2022

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

  • DRUG FACTS

  • ACTIVE INGREDIENT

    Cetirizine HCl 10 mg

  • PURPOSE

    Antihistamine

  • INDICATIONS & USAGE

    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

    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 DOCTOR

    Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.

  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.

  • WHEN USING

    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

    Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

  • PREGNANCY OR BREAST FEEDING

    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).

  • DOSAGE & ADMINISTRATION

    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

    Other information

    • store between 20° to 25°C (68°to 77°F)
  • INACTIVE INGREDIENT

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

  • QUESTIONS

    Questions or comments? 1-800-632-6900

  • PRINCIPAL DISPLAY PANEL

    Cetirizine Hydrochloride Tablets 10mg-70ct-Carton

    Cetirizine Hydrochloride Tablets 10mg-365ct-Carton

    Cetirizine Hydrochloride Tablets 10mg-365ct-Bottle labelCetirizine Hydrochloride tablets 10mg-70ct-Bottle label

  • INGREDIENTS AND APPEARANCE
    ALLERGY 
    cetirizine hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41226-692
    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
    STARCH, CORN (UNII: O8232NY3SJ)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    POVIDONE (UNII: FZ989GH94E)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Colorwhite ((white to off white)) Scoreno score
    ShapeRECTANGLE (Rounded-off rectangular shaped) Size10mm
    FlavorImprint Code J;220
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41226-692-651 in 1 CARTON05/11/2021
    1365 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:41226-692-142 in 1 CARTON05/11/2021
    270 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07893305/11/2021
    Labeler - Kroger Company (006999528)
    Registrant - TIME CAP LABORATORIES, INC. (037052099)
    Establishment
    NameAddressID/FEIBusiness Operations
    MARKSANS PHARMA LIMITED925822975manufacture(41226-692)