Label: CETIRIZINE HYDROCHLORIDE tablet

  • NDC Code(s): 16571-401-10
  • Packager: Rising Pharma Holdings, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated February 22, 2024

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  • Active Ingredient (in each tablet)

    Cetirizine HCl USP 5 mg

  • Purpose

    Antihistimine

  • 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 a doctor before use if you have 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

    • 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 and ask a doctor if an allergic reaction to this 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. (1-800-222-1222)

  • Directions


    Adults and children 6 years and over
    1 to 2 tablets once daily depending upon severity of symptoms; do not take more than 2 tablets in 24 hours

    Adults 65 years and over
    1 tablet once a day; do not take more than 1 tablet in 24 hours

    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

    129575

  • PRINCIPAL DISPLAY PANEL-100'S COUNT

    Rising NDC 16571-401-10

    Original Prescription Strength

    Cetirizine Hydrochloride Tablets USP 5 mg

    Antihistamine
    ALLERGY
    Indoor & Outdoor Allergies
    24 Hour Relief of:
    •Sneezing
    •Runny Nose
    •Itchy, Watery Eyes
    •Itchy Throat or Nose

    100 Tablets

    T10 - M.L. G/1430

    cetrizine-5mg-1

    cetrizine-5mg-2

    cetrizine-5mg-3

  • PRINCIPAL DISPLAY PANEL

    T20 - M.L. G/25/2188

    cetrizine-5mg-4

    cetrizine-5mg-5

    cetrizine-5mg-6

  • INGREDIENTS AND APPEARANCE
    CETIRIZINE HYDROCHLORIDE 
    cetirizine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:16571-401
    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
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    lactose (UNII: J2B2A4N98G)  
    magnesium stearate (UNII: 70097M6I30)  
    starch, corn (UNII: O8232NY3SJ)  
    polyethylene glycol (UNII: 3WJQ0SDW1A)  
    povidone (UNII: FZ989GH94E)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorWHITE (White) Scoreno score
    ShapeBULLET (Barrel Shaped) Size7mm
    FlavorImprint Code CTN;5
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:16571-401-10100 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 - Rising Pharma Holdings, Inc. (116880195)
    Registrant - Unique Pharmaceutical Laboratories (917165052)
    Establishment
    NameAddressID/FEIBusiness Operations
    Unique Pharmaceutical Laboratories650434645ANALYSIS(16571-401) , MANUFACTURE(16571-401)
    Establishment
    NameAddressID/FEIBusiness Operations
    Unique Pharmaceutical Laboratories864354608analysis(16571-401) , manufacture(16571-401)
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