24 HOUR ALLERGY LIL DRUG STORE PRODUCTS (CETIRIZINE HYDROCHLORIDE) TABLET [LIL' DRUG STORE PRODUCTS, INC.]

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24 HOUR ALLERGY LIL DRUG STORE PRODUCTS (CETIRIZINE HYDROCHLORIDE) TABLET [LIL' DRUG STORE PRODUCTS, INC.]
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NDC 66715-6950-0
Set ID 814183e3-711e-4eee-bcc1-837e19601df6
Category HUMAN OTC DRUG LABEL
Packager Lil' Drug Store Products, Inc.
Generic Name
Product Class
Product Number
Application Number ANDA209274
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each tablet)

    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 (1-800-222-1222) right away.

  • Directions

    adults and children 6 years and overone 10 mg tablet once daily; do not take more than one 10 mg tablet 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 between 20° to 25°C (68° to 77°F)
    • contains no ingredient made from a gluten-containing grain (wheat, barley or rye)
  • Inactive ingredients

    colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide

  • Questions or comments?

    Call toll-free 1-877-507-6516 (M-F 8AM-4:30PM CST)

  • PRINCIPAL DISPLAY PANEL - 5 Tablet Blister Pack Carton

    QUALITY
    ⋆ GUARANTEED ⋆

    Compare to the Active
    Ingredient in Zyrtec®*

    24 Hour
    Allergy

    Indoor & Outdoor

    Cetirizine HCl Tablets, 10 mg
    Antihistamine

    Relieves

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

    ACTUAL SIZE

    5
    Tablets

    Lil'
    Drug Store®

    PRINCIPAL DISPLAY PANEL - 5 Tablet Blister Pack Carton
  • INGREDIENTS AND APPEARANCE
    24 HOUR ALLERGY  LIL DRUG STORE PRODUCTS
    cetirizine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66715-6950
    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
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Croscarmellose Sodium (UNII: M28OL1HH48)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    Lactose Monohydrate (UNII: EWQ57Q8I5X)  
    Magnesium Stearate (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    Titanium Dioxide (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorWHITEScore2 pieces
    ShapeOVALSize9mm
    FlavorImprint Code G;4
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66715-6950-01 in 1 CARTON06/01/2018
    15 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20927406/01/2018
    Labeler - Lil' Drug Store Products, Inc. (093103646)
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