Label: CETIRIZINE HYDROCHLORIDE tablet

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

Drug Label Information

Updated March 25, 2024

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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 over

    Ask a doctor

    Children under 6 years of age

    Ask a doctor

    Consumers with liver or kidney disease

    Ask 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 1-844-874-7464

  • SPL UNCLASSIFIED SECTION

    Manufactured by:

    Unique Pharmaceutical Labs.

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


    Distributed by:

    Rising Pharma holdings, Inc.
    East Brunswick, NJ 08816

     

    M. L. G/1430    Jul. 2020

     

    126406

    Repackaged By: Preferred Pharmaceuticals Inc

  • PRINCIPAL DISPLAY PANEL-100'S COUNT

    ———PRINCIPAL DISPLAY PANEL———
    Rising®

    Repackaged By: Preferred Pharmaceuticals Inc

    NDC 68788-0790
    Original Prescription Strength
    Cetirizine Hydrochloride Tablets USP 10 mg
    6 yrs & older

    Cetirizine Hydrochloride Tablet 10mg


  • INGREDIENTS AND APPEARANCE
    CETIRIZINE HYDROCHLORIDE 
    cetirizine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68788-0790(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)  
    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:68788-0790-114 in 1 BOTTLE; Type 0: Not a Combination Product10/01/2009
    2NDC:68788-0790-515 in 1 BOTTLE; Type 0: Not a Combination Product10/01/2009
    3NDC:68788-0790-330 in 1 BOTTLE; Type 0: Not a Combination Product10/01/2009
    4NDC:68788-0790-660 in 1 BOTTLE; Type 0: Not a Combination Product10/01/2009
    5NDC:68788-0790-990 in 1 BOTTLE; Type 0: Not a Combination Product10/01/2009
    6NDC:68788-0790-0100 in 1 BOTTLE; Type 0: Not a Combination Product10/01/2009
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07782910/01/2009
    Labeler - Preferred Pharmaceuticals, Inc. (791119022)
    Registrant - Preferred Pharmaceuticals, Inc. (791119022)
    Establishment
    NameAddressID/FEIBusiness Operations
    Preferred Pharmaceuticals, Inc.791119022REPACK(68788-0790)
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