WAL-ZYR (CETIRIZINE HCL) CAPSULE [WALGREENS]

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WAL-ZYR (CETIRIZINE HCL) CAPSULE [WALGREENS]
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NDC 0363-0921-25, 0363-0921-40
Set ID e0c8457e-c77e-463d-9419-5876faf1c98c
Category HUMAN OTC DRUG LABEL
Packager Walgreens
Generic Name
Product Class
Product Number
Application Number NDA022429
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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

    • do not chew, crush, or dissolve capsule before swallowing 
    • 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 1-877-753-3935 Monday-Friday 9AM-5PM EST

  • Principal Display Panel

    Compare to Zyrtec® active ingredient≠≠

    ORIGINAL PRESCRIPTION STRENGTH

    Relieves symptoms associated with allergies

    24 Hour Allergy

    Cetirizine HCI Capsules 10 mg

    Antihistamine

    • 24 hour relief of runny nose, sneezing, itchy throat or nose & itchy, watery eyes

    INDOOR & OUTDOOR ALLERGIES | 24 HOUR SYMPTOM RELIEF

    SOFTGELS**

    (**Liquid-Filled Capsules)

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

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

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

    DISTRIBUTED BY: WALGREEN CO.

    200 WILMOT RD., DEERFIELD, IL 60015

    walgreens.com

    PRODUCT OF U.S.A.

  • Package Labeling

    Cetirizine HCI 10 mg

    WELL at WALGREENs 24 Hour Allergy Relief

  • INGREDIENTS AND APPEARANCE
    WAL-ZYR 
    cetirizine hcl capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0921
    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 CE1
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-0921-401 in 1 BOX02/06/2018
    140 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:0363-0921-251 in 1 BOX02/06/2018
    225 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02242902/06/2018
    Labeler - Walgreens (008965063)
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