Label: WAL-ZYR D- cetirizine hydrochloride and pseudoephedrine hydrochloride tablet, film coated, extended release

  • NDC Code(s): 0363-0989-12, 0363-0989-24
  • Packager: Walgreen Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated January 25, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each extended-release tablet)Purpose
    Cetirizine HCl, USP 5 mgAntihistamine
    Pseudoephedrine HCl, USP 120 mgNasal Decongestant
  • Uses

    • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
      • runny nose
      • sneezing
      • itchy, watery eyes
      • itching of 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) (cer tain 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 at 1-800-222-1222.

  • 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

    • store between 20° to 25°C (68° to 77°F)
    • do not use if carton is opened or if the blister unit is broken
    • see side panel for batch number and expiration date
  • Inactive ingredients

    hydroxyethyl cellulose, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, stearic acid, titanium dioxide

    Imprinting Ink Contents: ammonium hydroxide, iron oxide black, isopropyl alcohol, N-butyl alcohol, propylene glycol, shellac glaze

  • Questions?

    call toll free 1-800-818-4555 weekdays

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY: WALGREEN CO.
    200 WILMOT RD., DEERFIELD, IL 60015

  • PRINCIPAL DISPLAY PANEL - 12 Tablet Blister Pack Carton

    ORIGINAL PRESCRIPTION STRENGTH
    NDC 0363-0989-12

    Walgreens

    Compare to the active ingredients in
    Zyrtec-D® 12 Hour††

    • WALGREENS •
    PHARMACIST RECOMMENDED†

    Allergy Relief D12

    ALLERGY & CONGESTION
    CETIRIZINE HYDROCHLORIDE 5 mg / ANTIHISTAMINE
    PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg / NASAL DECONGESTANT

    12 Hour
    Extended-Release Tablets, USP
    Indoor & Outdoor Allergies

    • Relief of sneezing, itchy, watery eyes, sinus pressure, runny nose,
      itchy throat or nose & nasal congestion

    12 EXTENDED-RELEASE TABLETS

    ACTUAL SIZE

    PRINCIPAL DISPLAY PANEL - 12 Tablet Blister Pack Carton
  • INGREDIENTS AND APPEARANCE
    WAL-ZYR D 
    cetirizine hydrochloride and pseudoephedrine hydrochloride tablet, film coated, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0989
    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
    HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    AMMONIA (UNII: 5138Q19F1X)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    BUTYL ALCOHOL (UNII: 8PJ61P6TS3)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHELLAC (UNII: 46N107B71O)  
    HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%) (UNII: ZYD53NBL45)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeROUND (circular) Size9mm
    FlavorImprint Code 915
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-0989-122 in 1 CARTON11/01/2018
    16 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:0363-0989-244 in 1 CARTON11/01/2018
    26 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09092211/01/2018
    Labeler - Walgreen Company (008965063)
    Registrant - Sun Pharmaceutical Industries Limited (650172430)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sun Pharmaceutical Industries Limited650445203ANALYSIS(0363-0989) , MANUFACTURE(0363-0989)
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