Label: CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE- cetirizine hydrochloride, pseudoephedrine hydrochloride tablet, film coated, extended release

  • NDC Code(s): 45802-147-53, 45802-147-62
  • Packager: Padagis Israel Pharmaceuticals Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated November 4, 2021

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  • Active ingredients (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
    •
    sneezing
    •
    itchy, watery eyes
    •
    itching of the nose or throat
    •
    nasal congestion
    •
    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. (1-800-222-1222)

  • Directions

    •
    do not break or chew tablet; swallow tablet whole
     
    adults and children 12 years and over
     
    take 1 tablet every 12 hours; do not take more than 2 tablets in 24 hours.
     
    adults 65 years and over
     
    ask a doctor
     
    children under 12 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)
    •
    do not use if blister unit is broken or torn
    •
    see side panel for lot number and expiration date
    •
    meets USP Dissolution Test 2
  • Inactive ingredients

    colloidal silicon dioxide, hypromellose, lactose monohydrate, low-substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide

  • Questions or comments?

    1-800-719-9260

  • Package/Label Principal Display Panel

    Compare to Zyrtec-D®

    active ingredients

    Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride

    Extended Release Tablets

    5 mg/120 mg

    Antihistamine / Nasal Decongestant

    12 Hour Relief of:

    Sneezing

    Itchy, Watery Eyes

    Runny Nose

    Itchy Throat or Nose

    Sinus Pressure

    Nasal Congestion

    Original Prescription Strength

    actual size

    Indoor & Outdoor Allergies

    12 Extended Release Tablets

    Allergy & Congestion

    Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride Extended Release Tablets, 5 mg/120 mg Carton Image 1
    Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride Extended Release Tablets, 5 mg/120 mg Carton Image 2
  • INGREDIENTS AND APPEARANCE
    CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE 
    cetirizine hydrochloride, pseudoephedrine hydrochloride tablet, film coated, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45802-147
    Route of AdministrationORAL
    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)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 2165RE0K14)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code L147
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:45802-147-5312 in 1 CARTON03/31/2020
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:45802-147-6224 in 1 CARTON03/31/2020
    21 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21071903/31/2020
    Labeler - Padagis Israel Pharmaceuticals Ltd (600093611)
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