Label: ALLERGY RELIEF-D- cetirizine hydrochloride and pseudoephedrine hydrochloride tablet, extended release

  • NDC Code(s): 69842-994-12, 69842-994-24
  • Packager: CVS PHARMACY
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated January 12, 2024

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

View All Sections
  • 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) (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 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: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895

  • PRINCIPAL DISPLAY PANEL - 12 Tablet Blister Pack Carton

    CVSHealth®

    Compare to the active
    ingredients in Zyrtec-D® 12Hr Tablets*

    Indoor & Outdoor Allergies

    Original Prescription Strength

    NDC 69842-994-12

    Allergy & Congestion

    Allergy Relief-D

    CETIRIZINE HYDROCHLORIDE &
    PSEUDOEPHEDRINE HYDROCHLORIDE
    EXTENDED-RELEASE TABLETS, USP

    12
    HOUR

    5 mg/120 mg

    Antihistamine; Nasal decongestant

    12 Hour 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
    ALLERGY RELIEF-D 
    cetirizine hydrochloride and pseudoephedrine hydrochloride tablet, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-994
    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)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeROUND (Circular) Size9mm
    FlavorImprint Code 915
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-994-122 in 1 CARTON06/30/2019
    16 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:69842-994-244 in 1 CARTON06/30/2019
    26 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09092206/30/2019
    Labeler - CVS PHARMACY (062312574)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sun Pharmaceutical Industries Limited650445203ANALYSIS(69842-994) , MANUFACTURE(69842-994)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials

More Info on this Drug

Get Label RSS Feed, View NDC Code(s)NEW!