Label: ALLEROFF- cetirizine hydrochloride syrup

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

Drug Label Information

Updated January 15, 2010

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  • ACTIVE INGREDIENT


    (in each 5 ml teaspoonful) Cetirizine HCL 5 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


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

    See bottom panel for lot number and expiration date

  • DOSAGE & ADMINISTRATION

    Use only with enclosed dosing cup

    Adults and Children 6 years and over             1 teaspoonful (5ml) ot 2 teaspoonful (10ml) once daily depending upon severity of symptoms; do not take more than 2 teaspoonful (10ml) in 24        hours

    Adults 65 years and over                               1 teaspoonful (5ml) once daily; do not take more than 1 teaspoonful (5ml) in 24 hours

    Children 2 to under 6 years of age                   1/2 teaspoonful (2.5ml) once daily.If needed, dose can be increased to a maximum of 1 teaspoon (5ml) once daily or 1/2 teaspoonful (2.5ml) every 12 hours. Do not give more than 1 teaspoonful (5ml) in 24 hours

    Children under 2 years of age                          Ask a Doctor

    Consumer with liver or kidney disease             Ask a Doctor

  • INACTIVE INGREDIENT

    Citric and monohydrate, Sodium Benzoate, Sodium Citrate Tribasic Dihydrate, FDC Red Nº 40, Disodium Edetate, Strawberry Essence Liquid, Glycerol, Saccharin Sodium, Sorbitol, Purified Water

  • PRINCIPAL DISPLAY PANEL

    Image of Carton LabelEnter section text here

  • INGREDIENTS AND APPEARANCE
    ALLEROFF 
    cetirizine hydrochloride syrup
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:16853-1261
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (Cetirizine - UNII:YO7261ME24) CETIRIZINE HYDROCHLORIDE1 mg
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) 0.080 mg
    SODIUM BENZOATE (UNII: OJ245FE5EU) 0.100 mg
    SODIUM CITRATE (UNII: 1Q73Q2JULR) 0.090 mg
    FD&C RED NO. 40 (UNII: WZB9127XOA) 0.003 mg
    EDETATE DISODIUM (UNII: 7FLD91C86K) 0.025 mg
    GLYCERIN (UNII: PDC6A3C0OX) 25 mg
    SACCHARIN SODIUM (UNII: SB8ZUX40TY) 0.075 mg
    SORBITOL (UNII: 506T60A25R) 30 mg
    WATER (UNII: 059QF0KO0R) 100 mL
    STRAWBERRY (UNII: 4J2TY8Y81V) 0.07 mg
    Product Characteristics
    Colorpink (pink) Score    
    ShapeSize
    FlavorSTRAWBERRY (Strawberry) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:16853-1261-11 in 1 CARTON
    2NDC:16853-1261-22 in 1 PACKAGE, COMBINATION
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02215501/15/2010
    Labeler - Corporacion Infarmasa (934098294)
    Establishment
    NameAddressID/FEIBusiness Operations
    Corporacion Infarmasa934098294manufacture
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