Label: CETIRIZINE HCL capsule

  • NDC Code(s): 30142-995-25, 30142-995-40, 30142-995-50
  • Packager: KROGER COMPANY
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated May 19, 2022

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  • 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 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.

  • 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 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 at 20º-25ºC (68º-77ºF)
    • avoid high humidity and excessive heat above 40ºC (104ºF)
    • 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 1-800-632-6900

  • SPL UNCLASSIFIED SECTION

    Zyrtec® is a registered trademark of Johnson & Johnson

    Corporation, New Brunswick, New Jersey 08933. Johnson & Johnson

    Corporation is not affiliated with The Kroger Co. or this product.

    DISTRIBUTED BY

    THE KROGER CO.,

    CINCINNATI,

    OHIO 45202

    QUALITY GUARANTEE

    800-632-6900

    www.kroger.com

    TAMPER EVIDENT: DO NOT USE IF IMPRINTED

    SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

    KEEP THIS CARD FOR COMPLETE

    WARNINGS AND PRODUCT INFORMATION

    L0000553

    R0122

  • Principal Display Panel

    COMPARE TO the active ingredient
    of ZYRTEC® LIQUID GELS *See back panel

    Kroger

    All Day
    Allergy

    Cetirizine Hydrochloride
    Capsules, 10 mg

    Antihistamine

    INDOOR & OUTDOOR

    ALLERGIES

    24 HOUR RELIEF OF:

    Sneezing, Runny Nose; Itchy, Watery Eyes

    & Itchy Throat or Nose

    24

    HOUR

    SYMPTOM

    RELIEF

    actual size

    40 SOFTGELS†

    †liquid-filled capsules

    40's card

  • INGREDIENTS AND APPEARANCE
    CETIRIZINE HCL 
    cetirizine hcl capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30142-995
    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
    ColororangeScoreno score
    ShapeOVALSize13mm
    FlavorImprint Code CE1
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:30142-995-251 in 1 CARTON06/03/2019
    125 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:30142-995-401 in 1 CARTON06/03/2019
    240 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    3NDC:30142-995-501 in 1 CARTON06/03/2019
    350 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02242906/03/2019
    Labeler - KROGER COMPANY (006999528)
    Registrant - Bionpharma Inc. (079637826)
    Establishment
    NameAddressID/FEIBusiness Operations
    Patheon Softgels Inc.002193829manufacture(30142-995)
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