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

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

  • 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)