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

  • NDC Code(s): 58602-703-09, 58602-703-53, 58602-703-75, 58602-703-76
  • Packager: Aurohealth LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated November 7, 2024

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  • Drug Facts

    Active ingredients (in each extended release tablet)
    Cetirizine HCl USP 5 mg
    Pseudoephedrine HCl  USP 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 carton is opened or if individual blister units are torn or broken
  • Inactive ingredients

    colloidal silicon dioxide, croscarmellose sodium, ferric oxide, hypromellose, magnesium stearate, microcrystalline cellulose.

    Questions or comments?
    call 1-855-274-4122
    (Monday - Friday 8:30 AM to 5:00 PM EST)

    Distributed by: AUROHEALTH LLC
    279 Princeton-Hightstown Road
    East Windsor, NJ 08520

    Made in India

    Code: AP/DRUGS/04/2016


  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -5 mg/120 mg (12 x 2) Blister Carton

    AUROHEALTH
    NDC 58602-703-09

    *Compare to the active
    ingredients of Zyrtec-D®

    Original Prescription Strength
    Cetirizine Hydrochloride and
    Pseudoephedrine Hydrochloride
    Extended-Release Tablets, USP
    5 mg/ 120 mg
    Antihistamine/Nasal Decongestant

    Indoor & Outdoor
    Allergies

    ALLERY + SINUS

    NASAL CONGESTION + SINUS  PRESSURE

    12 Hour     relief of

        Sneezing

        Runny Nose

        Itchy, Watery Eyes

        Itchy Throat or Nose

    Actual Size

    24
    EXTENDED-RELEASE TABLETS

    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -5 mg/120 mg (12 x 2) Blister Carton

  • 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:58602-703
    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)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    Product Characteristics
    ColorYELLOW (Pale Yellow to Yellow) Scoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code K15
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58602-703-764 in 1 CARTON03/08/2023
    16 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:58602-703-752 in 1 CARTON03/08/2023
    26 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:58602-703-5312 in 1 CARTON03/08/2023
    31 in 1 BLISTER PACK; Type 0: Not a Combination Product
    4NDC:58602-703-0912 in 1 CARTON03/08/2023
    42 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21240903/08/2023
    Labeler - Aurohealth LLC (078728447)
    Establishment
    NameAddressID/FEIBusiness Operations
    APL HEALTHCARE LIMITED650918514ANALYSIS(58602-703) , MANUFACTURE(58602-703)
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