Label: CETIRIZINE HYDROCHLORIDE tablet, film coated

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

Drug Label Information

Updated May 27, 2013

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  • Active ingredient (in each tablet)

    Cetirizine hydrochloride USP, 10 mg

  • Purpose

    Antihistamine

  • 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

    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.

  • Directions

    adults and children 6 years and overone 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 severe symptoms.

    adults 65 years and over

    ask a doctor

    children under 6 years of age

    ask a doctor

    consumers with liver or kidney disease

    ask a doctor
  • Other information

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

  • Inactive ingredients

    corn starch, lactose monohydrate, povidone, magnesium stearate and opadry white. The components of opadry white are: hydroxypropyl methylcellulose, polyethylene glycol 400, titanium dioxide

  • Questions or comments?

    call toll free 1-800-206-7821

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 16714-271-02

    Cetirizine Hydrochloride Tablets, USP 10 mg

    6 Years and Older

    Allergy

    Antihistamine

    24 Hour Relief of

    •
    runny nose
    •
    sneezing
    •
    itchy, watery eyes
    •
    itching of the nose or throat

    NORTHSTAR

    100 Tablets

    Cetirizine HCl 10mg Tablets #30
  • INGREDIENTS AND APPEARANCE
    CETIRIZINE HYDROCHLORIDE 
    cetirizine hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66116-417(NDC:16714-271)
    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
    STARCH, CORN (UNII: O8232NY3SJ)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    POVIDONE K29/32 (UNII: 390RMW2PEQ)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeCAPSULESize9mm
    FlavorImprint Code S;521
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66116-417-3030 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07886210/19/2009
    Labeler - MedVantx, Inc. (806427725)
    Registrant - Northstar Rx LLC (830546433)
    Establishment
    NameAddressID/FEIBusiness Operations
    Blenheim Pharmacal, Inc.171434587REPACK(66116-417)
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