Label: CETIRIZINE HYDROCHLORIDE tablet

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

Drug Label Information

Updated April 7, 2010

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  • ACTIVE INGREDIENT

    (in each Tablet)
    Cetirizine HCI 10mg
  • PURPOSE

    ANTIHISTAMINE
    24 Hour Relief of Indoor and Outdoor Allergies

    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

    • drowsines may occur
    • avoid alcoholic drinks
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • be careful when driving a motor vehicle or operating machinary.
  • 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 Poison Control Center right away.

  • Directions

    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.
    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 and inactive ingredients

    Other information
    • store between 20° to 25°C (68° to 77°F)
    Inactive ingredients

    anhydrous lactose, colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, sodium lauryl sulfate, titanium dioxide, and triacetin

  • Questions

    Call 1-800-262-5244

    Monday though Friday 9AM – 2PM MST

    Distributed by:

    RejuviLife, Phoenix, AZ

    RejuviLife is a trademark of Apotheca Inc.

  • PACKAGE LABEL AND PRINCIPAL DISPLAY PANEL

    NDC 12634-987-71
    CETIRIZINE HCI
    Antihistamine
    Indoor and Outdoor Allergies
    24 Hour Relief of Sneezing, Runny Nose, Itchy,
    Watery Eyes, Itchy Throat or Nose.
    Allergy Tablets
    RejuviLife
    30 Tablets
    10 MG
    image of label

  • INGREDIENTS AND APPEARANCE
    CETIRIZINE HYDROCHLORIDE 
    cetirizine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12634-987(NDC:0378-3637)
    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
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    HYPROMELLOSE (UNII: 3NXW29V3WO)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Colorwhite (WHITE) Scoreno score
    ShapeBULLET (Barrel Shaped) Size8mm
    FlavorImprint Code M;C37
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:12634-987-966 in 1 BOTTLE, PLASTIC
    2NDC:12634-987-977 in 1 BOTTLE, PLASTIC
    3NDC:12634-987-0010 in 1 BOTTLE, PLASTIC
    4NDC:12634-987-8020 in 1 BOTTLE, PLASTIC
    5NDC:12634-987-7130 in 1 BOTTLE, PLASTIC
    6NDC:12634-987-5050 in 1 BOTTLE, PLASTIC
    7NDC:12634-987-01100 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07667701/01/2010
    Labeler - Apotheca Inc. (051457844)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Inc.051457844repack, relabel
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