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

  • NDC Code(s): 11822-9994-1, 11822-9994-2
  • Packager: RITE AID
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated August 8, 2023

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)Purposes
    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: RITE AID,
    200 NEWBERRY COMMONS, ETTERS, PA 17319

  • PRINCIPAL DISPLAY PANEL - 12 Tablet Blister Card Carton

    NDC 11822-9994-1
    12 HOUR

    Compare to the active ingredient of Zyrtec-D® 12hr*

    ORIGINAL PRESCRIPTION STRENGTH

    ALLERGY RELIEF
    NASAL DECONGESTANT

    CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE
    HYDROCHLORIDE EXTENDED-RELEASE TABLETS, USP 5 mg/120 mg

    ANTIHISTAMINE/NASAL DECONGESTANT

    INDOOR & OUTDOOR ALLERGIES
    ALLERGY & SINUS

    12 HOUR RELIEF OF
    Sneezing • Runny nose • Nasal congestion
    Itchy, watery eyes • Sinus pressure
    Itchy throat or nose

    ACTUAL
    SIZE

    12
    TABLETS
    (2 blister cards of 6 tablets each)

    PRINCIPAL DISPLAY PANEL - 12 Tablet Blister Card Carton
  • INGREDIENTS AND APPEARANCE
    ALLERGY RELIEF-D 
    cetirizine hydrochloride and pseudoephedrine hydrochloride tablet, film coated, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-9994
    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:11822-9994-12 in 1 CARTON07/20/2023
    16 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:11822-9994-26 in 1 BLISTER PACK; Type 0: Not a Combination Product07/20/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09092207/20/2023
    Labeler - RITE AID (014578892)
    Registrant - Sun Pharmaceutical Industries Limited (650172430)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sun Pharmaceutical Industries Limited650445203MANUFACTURE(11822-9994)
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!