Label: CETIRIZINE HYDROCHLORIDE tablet

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

Drug Label Information

Updated February 9, 2011

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

  • Active ingredient

    (in each tablet)

    Cetirizine HCl 10 mg

  • Purpose

    Antihistamine

  • Keep out of reach of children

    In case of overdose, get medical help or contact a Poison Control Center right away.

  • 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 reactions 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.
  • 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 overask 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, hypromellose, lactose monohydrate, macrogol, magnesium stearate, povidone and titanium dioxide.

    Questions? 1-800-525-8747

    Manufactured in India by Sandoz Private Ltd.,

    for Sandoz Inc., Princeton, NJ 08540

    Rev.02/2008

    Repackaged by:

    Rebel Distributors Corp

    Thousand Oaks, CA 91320

  • Principal Display Panel

    NDC 21695-709-10 Bottle of 10

    NDC 21695-709-14 Bottle of 14

    NDC 21695-709-20 Bottle of 20

    NDC 21695-709-30 Bottle of 30

    Cetirizine HCl Tablets

    10 mg

    antihistamine

    Do not use if individual blister unit is open or torn

    ALLERGY

    Indoor & Outdoor Allergies

    24 hour Relief of

    • Sneezing
    • Runny Nose
    • Itchy, Watery Eyes
    • Itchy Throat or Nose
    Cetirizine HCl 10mg

  • INGREDIENTS AND APPEARANCE
    CETIRIZINE HYDROCHLORIDE 
    cetirizine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21695-709(NDC:0781-1684)
    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)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POVIDONE (UNII: FZ989GH94E)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    Product Characteristics
    ColorWHITE (white to off-white) Scoreno score
    ShapeROUND (round shape) Size8mm
    FlavorImprint Code SZ;906
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:21695-709-1414 in 1 BOTTLE
    2NDC:21695-709-2020 in 1 BOTTLE
    3NDC:21695-709-3030 in 1 BOTTLE
    4NDC:21695-709-1010 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07794612/27/2007
    Labeler - Rebel Distributors Corp (118802834)
    Establishment
    NameAddressID/FEIBusiness Operations
    Rebel Distributors Corp118802834RELABEL, REPACK