Label: ALLEROFF- cetirizine hydrochloride tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated February 15, 2010

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  • ACTIVE INGREDIENT


    Cetirizine HCL 10 mg..........Antihistamine
  • ASK DOCTOR


    Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.
  • ASK DOCTOR/PHARMACIST


    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
  • 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 hidroxyzine

  • 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
  • STOP USE

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

  • PURPOSE


    Uses

    Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

    • Runny Nose
    • Itchy,water eyes
    • Itching of the nose or throat
    • Sneezing
  • QUESTIONS

    If you have questions of a medical nature, please contact your pharmacist, doctor or health care profesional

    Questions or comments? 561 338 5221

  • STORAGE AND HANDLING

    Do not use if blister unit is broken or lorn

    Store between 20ºC to 25ºC ( 68ºF to 77ºF)

  • DOSAGE & ADMINISTRATION

    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 strenght may be appropiate for less severe symptoms

    Adults 65 years and over                               Ask a Doctor

    Children under 6 years of age                         Ask a Doctor

    Consumer with liver or kidney disease             Ask a Doctor

  • INACTIVE INGREDIENT

    Microcrystalline Cellulose, Lactose Monohydrate, Crosscaramellose Sodium, Magnesium Stearate

  • PRINCIPAL DISPLAY PANEL


    Image of Carton Label

  • INGREDIENTS AND APPEARANCE
    ALLEROFF 
    cetirizine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:16853-1307
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (Cetirizine - UNII:YO7261ME24) CETIRIZINE HYDROCHLORIDE10.0 mg
    Inactive Ingredients
    Ingredient NameStrength
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) 150.0 mg
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) 5.0 mg
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) 50.0 mg
    MAGNESIUM STEARATE (UNII: 70097M6I30) 2.0 mg
    Product Characteristics
    Colorwhite (white) Scorescore with uneven pieces
    ShapeROUND (Tablet) Size8mm
    FlavorImprint Code None
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:16853-1307-200000000000003 in 1 BOX
    1NDC:16853-1307-1000000000010 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01983501/01/2010
    Labeler - Corporacion Infarmasa (934098294)
    Establishment
    NameAddressID/FEIBusiness Operations
    Corporacion Infarmasa934098294manufacture
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