Label: CETIRIZINE HYDROCHLORIDE- cetirizine tablet

  • NDC Code(s): 65162-045-03, 65162-045-50
  • Packager: Amneal Pharmaceuticals LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated August 8, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    (in each tablet)

    Cetirizine HCl, USP 5 mg

  • PURPOSE

    Antihistamine

  • INDICATIONS AND USAGE

    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

  • 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.

  • ASK DOCTOR

    Ask a doctor before use if you have liver or kidney disease.  Your doctor should determine if you need a different dose.

  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.

    When using this product

    ● 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

    Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding :

    • if breast-feeding: not recommended

    • if pregnant: ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    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

    Adults and children 6years and over1 tablet (5 mg) or 2 tablets (10 mg) once daily depending upon severity of symptoms; do not take more than 2 tablets (10 mg) in 24 hours.
    Adults 65years and over1 tablet (5 mg) once daily; do not take more than 1 tablet (5 mg) in 24 hours.
    Children under 6 years of ageask a doctor
    Consumers with liver or kidney diseaseask a doctor
  • OTHER INFORMATION

    Other information

    • store between 20° to 25°C (68° to 77°F)

  • INACTIVE INGREDIENTS

    Inactive ingredients

    lactose monohydrate, magnesium stearate, polyvinyl alcohol, polyethylene glycol, povidone, starch, talc and titanium dioxide.

  • OTC - QUESTIONS

    Questions or Comments?

    Call 1-877-835-5472

    Monday through Friday 9AM - 5PM EST.

  • SPL UNCLASSIFIED SECTION

    Distributed by: 
    Amneal Pharmaceuticals LLC
    Bridgewater, NJ08807

    Rev. 08-2023-01

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Label

    Carton
  • INGREDIENTS AND APPEARANCE
    CETIRIZINE HYDROCHLORIDE 
    cetirizine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65162-045
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24) CETIRIZINE HYDROCHLORIDE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeOVALSize6mm
    FlavorImprint Code IP;45
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65162-045-031 in 1 CARTON01/21/2010
    130 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:65162-045-50500 in 1 BOTTLE; Type 0: Not a Combination Product01/21/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07878001/21/2010
    Labeler - Amneal Pharmaceuticals LLC (123797875)
    Establishment
    NameAddressID/FEIBusiness Operations
    Amneal Pharmaceuticals of New York, LLC831227801analysis(65162-045) , label(65162-045) , manufacture(65162-045) , pack(65162-045)
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