Label: CETIRIZINE HCL AND PSEUDOEPHEDRINE HCL ER- cetirizine hcl and pseudoephedrine hcl tablet, film coated, extended release

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: CV
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated June 7, 2010

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  • Active Ingredient (in each extended release tablet)

    Cetirizine HCl 5 mg

    Pseudoephedrine HCl 120 mg

  • Purpose

    Antihistamine

    Nasal decongestant

  • Uses

    • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
      • runny nose
      • itchy, watery eyes
      • nasal congestion
      • sneezing
      • itching of the nose or throat
    • reduces swelling of nasal passages
    • temporarily relieves sinus congestion and pressure
    • temporarily restores freer breathing through the nose
  • 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.
    • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

    Ask a doctor before use if you have

    • heart disease
    • thyroid disease
    • diabetes
    • glaucoma
    • high blood pressure
    • trouble urinating due to an enlarged prostate gland
    • 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

    • do not use more than directed
    • 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.
    • you get nervous, dizzy, or sleepless
    • symptoms do not improve within 7 days or are accompanied by fever

    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

    • do not break or chew tablet; swallow tablet whole
    adults and children 12 years and overtake 1 tablet every 12 hours; do not take more than 2 tablets in 24 hours.
    adults 65 years and overask a doctor
    children under 12 years of ageask a doctor
    consumers with liver or kidney diseaseask a doctor
  • Other Information

    • Safety sealed: do not use if the imprinted bottle seal is open or torn (for bottle only).
    • DO NOT USE IF BLISTER UNIT IS BROKEN OR TORN (for blister package only).

    Store at 20°-25°C (68°-77°F) (see USP Controlled Room Temperature).

  • Inactive Ingredients

    Colloidal silicon dioxide, croscarmellose sodium, D & C yellow aluminum lake, hypromellose, iron oxide red, iron oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate, povidone, and titanium dioxide.

  • Questions or comments?

    1-800-525-8747

    Sandoz Inc.

    Princeton, NJ 08540

    05-2010M



    Relabeling of Additional Barcode by:
    Physicians Total Care, Inc.
    Tulsa, OK     74146

    HOW SUPPLIED:


    30 Tablets, Bottles              NDC 54868-5884-1

    60 Tablets, Bottles              NDC 54868-5884-0

    24 Tablets, Blister Pack      NDC 54868-5884-2

  • 5 mg/120 mg Label

    Cetirizine HCl and

    Pseudoephedrine HCl

    Extended Release Tablets

    5 mg/120 mg

    antihistamine/

    nasal decongestant

    Indoor & Outdoor Allergies

    ALLERGY & CONGESTION

    12 hour Relief of

    Runny Nose Itchy, Watery Eyes Sinus Pressure

    Sneezing Itchy Throat or Nose Nasal Congestion

    Cetirizine HCl and Pseudoephedrine HCl 5 mg and 120 mg Label

  • INGREDIENTS AND APPEARANCE
    CETIRIZINE HCL AND PSEUDOEPHEDRINE HCL  ER
    cetirizine hcl and pseudoephedrine hcl tablet, film coated, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54868-5884(NDC:0781-5285)
    Route of AdministrationORALDEA ScheduleCV    
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24) CETIRIZINE HYDROCHLORIDE5 mg
    PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE120 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    HYPROMELLOSE 2208 (15000 CPS) (UNII: Z78RG6M2N2)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POVIDONE (UNII: FZ989GH94E)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColoryellowScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code SZ912
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54868-5884-24 in 1 CARTON
    16 in 1 BLISTER PACK
    2NDC:54868-5884-130 in 1 BOTTLE
    3NDC:54868-5884-060 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07799103/31/2008
    Labeler - Physicians Total Care, Inc. (194123980)
    Establishment
    NameAddressID/FEIBusiness Operations
    Physicians Total Care, Inc.194123980relabel
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