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

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

View All Sections
  • 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:16853-1305
    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:16853-1305-200000000000001 in 1 BOX
    1NDC:16853-1305-1000000000010 in 1 BLISTER PACK
    2NDC:16853-1305-30000000002 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
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!