Label: 24 HOUR ALLERGY LIL DRUG STORE PRODUCTS- cetirizine hydrochloride tablet

  • NDC Code(s): 66715-6850-0
  • Packager: Lil' Drug Store Products, Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated November 4, 2014

If you are a consumer or patient please visit this version.

  • 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
    • 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 overTake one 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)
  • Inactive ingredients

    lactose monohydrate, magnesium stearate, polyethylene glycol, polyvinyl alcohol, povidone, starch, talc, titanium dioxide

  • Questions or comments?

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

  • PRINCIPAL DISPLAY PANEL - 5 Tablet 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 Carton
  • INGREDIENTS AND APPEARANCE
    24 HOUR ALLERGY   LIL DRUG STORE PRODUCTS
    cetirizine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66715-6850
    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
    Lactose monohydrate (UNII: EWQ57Q8I5X)  
    Magnesium stearate (UNII: 70097M6I30)  
    Polyethylene Glycols (UNII: 3WJQ0SDW1A)  
    Polyvinyl alcohol (UNII: 532B59J990)  
    povidones (UNII: FZ989GH94E)  
    Starch, Corn (UNII: O8232NY3SJ)  
    talc (UNII: 7SEV7J4R1U)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeROUNDSize8mm
    FlavorImprint Code IP46
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66715-6850-01 in 1 CARTON
    15 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07878011/01/2014
    Labeler - Lil' Drug Store Products, Inc (093103646)