Label: CETIRIZINE HCL- cetirizine hydrochloride capsule

  • NDC Code(s): 49738-211-12, 49738-211-25
  • Packager: SMART SENSE (Kmart)
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated November 9, 2020

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

  • Active Ingredient (in each capsule)

    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
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • avoid alcoholic drinks
    • be careful when driving a motor vehicle or operating machinery

    Stop use and ask a doctor if

    an allergic reation 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 overone 10 mg capsule once daily; do not take more than one 10 mg capsule 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 at 20°-25°C (68°-77°F)
    • avoid high humidity and excessive heat above 40°C (104°F)
    • protect from light
  • Inactive ingredients

    FD&C yellow #6, gelatin, glycerin, mannitol, pharmaceutical ink, polyethylene glycol, purified water, sodium hydroxide, sorbitan, sorbitol

  • Questions or comments?

    Call toll free 1-800-842-7886

  • PRINCIPAL DISPLAY PANEL

    COMPARE TO THE ACTIVE INGREDIENT OF ZYRTEC® LIQUID GELS*

    allergy softgels

    CETIRIZINE HCl CAPSULES, 10 mg • ANTIHISTAMINE

    INDOOR & OUTDOOR ALLERGIES

    24 HOUR RELIEF

    RELIEVES:

    • SNEEZING
    • RUNNY NOSE
    • ITCHY, WATERY EYES
    • ITCHY THROAT OR NOSE

    SOFTGELS

    *This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark ZYRTEC®.

    TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

    Distributed by: Kmart Corporation

    Hoffman Estates, IL 60179

    Shop kmart.com

  • Package Label

    Cetirizine HCI 10 mg

    SMART SENSE Allergy Softgels

     

  • INGREDIENTS AND APPEARANCE
    CETIRIZINE HCL 
    cetirizine hydrochloride capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49738-211
    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
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MANNITOL (UNII: 3OWL53L36A)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SORBITAN (UNII: 6O92ICV9RU)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    ColorYELLOWScoreno score
    ShapeCAPSULESize13mm
    FlavorImprint Code CET
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49738-211-251 in 1 PACKAGE05/01/201312/31/2021
    125 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:49738-211-121 in 1 BOX05/01/201312/31/2021
    212 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02242905/01/201312/31/2021
    Labeler - SMART SENSE (Kmart) (008965873)