Label: CETIRIZINE HCL capsule

  • NDC Code(s): 69452-265-15, 69452-265-86, 69452-265-88
  • Packager: Bionpharma Inc.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated December 29, 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 1-888-235-2466 (Mon - Fri 9AM - 5PM EST)

  • SPL UNCLASSIFIED SECTION

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

    KEEP THIS CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

    †This product is not manufactured or distributed by the owners of Zyrtec®

    Manufactured for:

    BIONPHARMA

    600 Alexander Road, Princeton, NJ 08540

    R0921

    L0000534

  • Principal Display Panel - 65's carton

    †compare to the active ingredient in Zyrtec®

    NDC 69452-265-88

    a+health TM

    cetirizine HCl capsules, 10 mg

    antihistamine

    indoor & outdoor allergies

    24 hour relief of:

    • sneezing
    • runny nose
    • itchy, watery eyes
    • itchy throat or nose

    65 softgels**

    **liquid-filled capsule

    carton

  • INGREDIENTS AND APPEARANCE
    CETIRIZINE HCL 
    cetirizine hcl capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69452-265
    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:69452-265-861 in 1 CARTON05/01/2019
    125 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:69452-265-151 in 1 CARTON05/01/2019
    240 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    3NDC:69452-265-881 in 1 CARTON05/01/2019
    365 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02242905/01/2019
    Labeler - Bionpharma Inc. (079637826)
    Registrant - Bionpharma Inc. (079637826)
    Establishment
    NameAddressID/FEIBusiness Operations
    Patheon Softgels Inc.002193829manufacture(69452-265)
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