ZERO ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET [EFFICIENT LABORATORIES INC]

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ZERO ALLERGY (CETIRIZINE HYDROCHLORIDE) TABLET [EFFICIENT LABORATORIES INC]
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NDC 58593-827-14
Set ID 51b3fc6e-851c-44de-8ca9-701dfc40e3fc
Category HUMAN OTC DRUG LABEL
Packager Efficient Laboratories Inc
Generic Name
Product Class
Product Number
Application Number ANDA077498
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  • 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).

  • ACTIVE INGREDIENT

    Active Ingredient (per tablet)                 Purpose


    Cetririzine HCl 10 mg ....................................Antihistamine


  • PURPOSE

    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

    Warnings

    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

  • DO NOT USE

    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.

    Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

  • KEEP OUT OF REACH OF CHILDREN

    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)


  • PREGNANCY OR BREAST FEEDING


    If pregnant or breast-feeding:

    • if breast-feeding: not recommended
    • if pregnant: ask a health professional before use.
  • DOSAGE & ADMINISTRATION

    Directions

    adults and children 6 years and over                  
    		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 sever symptoms
    adults 65 years and over
    		ask a doctor
    children 6 years of age
    		ask a doctor
    consumers with liver or kidney disease
    		ask a doctor
  • INDICATIONS & USAGE

    Othe information

    • TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.
    • store between 20 degrees to 25 degrees C (68 to 77 degrees F)
  • INACTIVE INGREDIENT

    Inactive ingredients

    corn starch, hypromellose, lactose monhydrate, magnesium stearate, polyethylene glycol, povidone, talc, titanium dioxide

  • QUESTIONS

    Questions?

    Call: 1-305-805-3456 M-F 9:00AM - 5:00PM EST

  • PRINCIPAL DISPLAY PANEL

    zeroallergy

  • INGREDIENTS AND APPEARANCE
    ZERO ALLERGY 
    cetirizine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58593-827
    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
    POVIDONE (UNII: FZ989GH94E)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeRECTANGLESize9mm
    FlavorImprint Code RI52
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58593-827-1414 in 1 BLISTER PACK; Type 0: Not a Combination Product04/01/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07749804/01/2013
    Labeler - Efficient Laboratories Inc (969044932)
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