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

  • NDC Code(s): 29300-313-22, 29300-313-24, 29300-313-61
  • Packager: Unichem Pharmaceuticals (USA), Inc.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated September 23, 2024

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  • SPL UNCLASSIFIED SECTION

    DRUG FACTS

  • ACTIVE INGREDIENTS

    (in each extended-release tablet)

    Cetirizine HCl USP 5 mg

    Pseudoephedrine HCl USP 120 mg

  • PURPOSE

  • SPL UNCLASSIFIED SECTION

    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 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 blister unit is torn or broken
    • keep the carton.  It contains important information.
  • INACTIVE INGREDIENT

  • SPL UNCLASSIFIED SECTION

    colloidal silicon dioxide, croscarmellose sodium, ferric oxide yellow, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide

  • QUESTIONS

  • SPL UNCLASSIFIED SECTION

    call 1-866-562-4616 from Monday to Friday between 8.00 AM to 8.00 PM, EST

    Manufactured by:

    UNICHEM LABORATORIES LTD.

    Pilerne Ind. Estate, Pilerne, Bardez,

    Goa 403511, India.

    Manufactured for:

    Unichem logo

    East Brunswick, NJ 08816.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Carton label
  • 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:29300-313
    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
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    HYPROMELLOSE 2208 (100000 MPA.S) (UNII: VM7F0B23ZI)  
    HYPROMELLOSE 2208 (4000 MPA.S) (UNII: 39J80LT57T)  
    HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorWHITE (White to Off White and White to Pale Yellow) Scoreno score
    ShapeROUND (Biconvex) Size10mm
    FlavorImprint Code U;313
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:29300-313-244 in 1 CARTON01/01/2025
    1NDC:29300-313-616 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:29300-313-222 in 1 CARTON01/01/2025
    2NDC:29300-313-616 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21050709/10/2024
    Labeler - Unichem Pharmaceuticals (USA), Inc. (181620514)
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