Label: CETIRIZINE HYDROCHLORIDE- cetirizine tablet

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

Drug Label Information

Updated February 22, 2012

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

View All Sections

  • Drug Facts

  • ACTIVE INGREDIENT

    (in each tablet)

    Cetirizine HCl 10 mg

  • PURPOSE

    Antihistamine

  • INDICATIONS AND USAGE

    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

  • 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 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 drink

    ● alcohol, sedatives, and tranquilizers may increase drowsiness

    ● be careful when driving a motor vehicle or operating machinery

  • WARNINGS

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

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding :

    • if breast-feeding: not recommended

    • if pregnant: ask a health professional

    before use.

  • 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.

  • DOSAGE AND ADMINISTRATION

    Adults andchildren 6years andoverOne 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 65years andoverAsk a doctor.
    Childrenunder 6 yearsof ageask a doctor
    Consumerswith liver orkidneydiseaseask a doctor
  • OTHER INFORMATION

    Other information

    • store between 20 to 25°C (68 to 77°F)

  • INACTIVE INGREDIENT

    Inactive ingredients

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

  • OTC - QUESTIONS

    Questions or Comments?

    Call 1-877-835-5472

    Monday through Friday 9AM-5PM EST

  • Distributed by:  Amneal Pharmaceuticals

    Glasgow, KY 42141

    Rev. 01-2009

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    4061bbde-figure-01
    4061bbde-figure-02
    4061bbde-figure-03
  • INGREDIENTS AND APPEARANCE
    CETIRIZINE HYDROCHLORIDE 
    cetirizine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65162-046
    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)  
    POLYVINYL ALCOHOL (UNII: 532B59J990)  
    POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeOVALSize8mm
    FlavorImprint Code IP;46
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65162-046-031 in 1 CARTON
    130 in 1 BOTTLE
    2NDC:65162-046-50500 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07878001/21/2010
    Labeler - Amneal Pharmaceuticals (123797875)
    Registrant - Amneal Pharmaceuticals (123797875)
    Establishment
    NameAddressID/FEIBusiness Operations
    Amneal Pharmaceuticals831227801ANALYSIS, LABEL, MANUFACTURE, PACK
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!