ZYRTEC (CETIRIZINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]

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ZYRTEC (CETIRIZINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]
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NDC 50580-779-12, 50580-779-25, 50580-779-40, 50580-779-65
Set ID 605adf29-734f-451a-8ff3-74be7b5814a6
Category HUMAN OTC DRUG LABEL
Packager Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
Generic Name
Product Class
Product Number
Application Number NDA022429
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • 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
    • 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.

    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
    • do not use if foil inner seal printed with "SAFETY SEAL®" is broken or missing
  • Inactive ingredients

    gelatin, glycerin, mannitol, pharmaceutical ink, polyethylene glycol 400, purified water, sodium hydroxide, sorbitan, sorbitol

  • Questions?

    call 1-800-343-7805 (toll-free) or 215-273-8755 (collect)

  • PRINCIPAL DISPLAY PANEL

    Original Prescription Strength

    NDC 50580-779-12

    ZYRTEC®
    ALLERGY

    INDOOR + OUTDOOR
    ALLERGIES

    Cetirizine HCl/
    antihistamine
    10 mg capsules

    LIQUID
    GELS

    24
    HOUR
    RELIEF OF

    • Sneezing
    • Runny Nose
    • Itchy, Watery Eyes
    • Itchy Throat or Nose

    (Actual Size)

    12
    LIQUID GELS*
    *LIQUID-FILLED CAPSULES
    10 mg each

    PRINCIPAL DISPLAY PANEL
  • INGREDIENTS AND APPEARANCE
    ZYRTEC 
    cetirizine hydrochloride capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50580-779
    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
    gelatin, unspecified (UNII: 2G86QN327L)  
    glycerin (UNII: PDC6A3C0OX)  
    mannitol (UNII: 3OWL53L36A)  
    polyethylene glycol 400 (UNII: B697894SGQ)  
    water (UNII: 059QF0KO0R)  
    sodium hydroxide (UNII: 55X04QC32I)  
    sorbitan (UNII: 6O92ICV9RU)  
    sorbitol (UNII: 506T60A25R)  
    Product Characteristics
    ColorYELLOW (Clear) Scoreno score
    ShapeOVALSize14mm
    FlavorImprint Code Z10
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50580-779-121 in 1 PACKAGE02/08/2010
    112 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:50580-779-251 in 1 PACKAGE02/08/2010
    225 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:50580-779-401 in 1 PACKAGE02/08/2010
    340 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:50580-779-6565 in 1 PACKAGE, COMBINATION; Type 0: Not a Combination Product02/08/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02242902/08/2010
    Labeler - Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division (878046358)
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