Label: CETIRIZINE HYDROCHLORIDE tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated January 18, 2020

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  • ACTIVE INGREDIENTS

    Active Ingredients (in each tablet)                                                Purpose

    Cetirizine HCl USP 10 mg................................................................Antihistimine

  • PURPOSE

    Antihistamine

  • 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
  • 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

    • drowsines may occur
    • avoid alcoholic drinks
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • be careful when driving a motor vehicle or operating machinary.
  • STOP USE

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

  • 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 Poison Control Center right away.

  • DIRECTIONS

    Adults and children 6
     years and over    		one 10 mg tablet once daily, do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms.
    Adults 65 years and overAsk a doctor
    Children under 6 years of ageAsk a doctor
    Consumers with liver or kidney diseaseAsk a doctor
  • OTHER INFORMATION

    store at 20° to 25°C (68° to 77°F)

    [See USP Controlled Room Temperature]

  • INACTIVE INGREDIENTS

    Hypromellose, lactose, magnesium stearate, maize starch, polyethylene glycol, povidone, titanium dioxide.

  • QUESTIONS?

    Call 1-866-562-4597

  • SPL UNCLASSIFIED SECTION

    Manufactured by:

    Unique Pharmaceutical Labs.

    (A Div. of J. B. Chemicals & Pharmaceuticals Ltd.),
    Mumbai 400 030, India


    Distributed by:

    Rising Pharmaceuticals, Inc.
    Saddle Brook, NJ 07663

     

    M. L. G/1430    May 2018

     

    120005


  • Cetirizine Hydrochloride

    Label Image
  • INGREDIENTS AND APPEARANCE
    CETIRIZINE HYDROCHLORIDE 
    cetirizine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50090-1089(NDC:16571-402)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24) CETIRIZINE HYDROCHLORIDE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
    magnesium stearate (UNII: 70097M6I30)  
    starch, corn (UNII: O8232NY3SJ)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorWHITE (White) Scoreno score
    ShapeBULLET (Barrel Shaped) Size8mm
    FlavorImprint Code CTN;10
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50090-1089-014 in 1 BOTTLE; Type 0: Not a Combination Product11/28/201408/31/2019
    2NDC:50090-1089-390 in 1 BOTTLE; Type 0: Not a Combination Product11/28/2014
    3NDC:50090-1089-130 in 1 BOTTLE; Type 0: Not a Combination Product11/28/2014
    4NDC:50090-1089-2100 in 1 BOTTLE; Type 0: Not a Combination Product11/28/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07782910/01/2009
    Labeler - A-S Medication Solutions (830016429)
    Establishment
    NameAddressID/FEIBusiness Operations
    A-S Medication Solutions830016429RELABEL(50090-1089) , REPACK(50090-1089)
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