Label: CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE tablet, film coated, extended release

  • NDC Code(s): 62756-915-60, 62756-915-62, 62756-915-73
  • Packager: Sun Pharmaceutical Industries, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated November 27, 2024

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  • Active ingredients

    Cetirizine HCl, USP 5 mg
    Pseudoephedrine HCl, USP 120 mg

  • Purposes

    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) (cer tain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks af ter 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 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 lot 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

  • Principal Display Panel - Showbox

    NDC 62756-915-62

    Original Prescription Strength
    Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride Extended-release Tablets, USP
    5 mg/120 mg
    Antihistamine/Nasal Decongestant
    Indoor & Outdoor Allergies
    ALLERGY & SINUS
    SUN PHARMA
    Actual Size
    DO NOT USE IF INDIVIDUAL BLISTER UNIT IS OPEN OR TORN
    12 Tablets (2 blister cards of 6 tablets each)

    13

  • Principal Display Panel - Blister pack

    Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release Tablet, USP

    5 mg/120 mg

    Mfg. by: Sun Pharmaceutical Ind. Ltd. India.

    spl-cetirizine-pseudoephedrine-blister

  • INGREDIENTS AND APPEARANCE
    CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE 
    cetirizine hydrochloride and pseudoephedrine hydrochloride tablet, film coated, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62756-915
    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)  
    HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
    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:62756-915-622 in 1 CARTON09/29/2012
    1NDC:62756-915-606 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:62756-915-734 in 1 CARTON09/29/2012
    2NDC:62756-915-606 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09092209/29/2012
    Labeler - Sun Pharmaceutical Industries, Inc. (146974886)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sun Pharmaceutical Industries Limited650445203ANALYSIS(62756-915) , MANUFACTURE(62756-915)
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