Label: CETIRIZINE HYDROCHLORIDE tablet

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

Drug Label Information

Updated October 1, 2019

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  • ACTIVE INGREDIENTS (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

    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 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 6years 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 1-866-562-4597

  • 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

    120004

    Repackaged By;

    Proficient Rx LP

    Thousand Oaks 91320

  • Cetirizine Hydrochloride Tablets USP 5 mg

    NDC 71205-093-30

    Original Prescription Strength

    Cetirizine Hydrochloride
    Tablets 5 mg

    30 Tablets

    71205-093-30
  • INGREDIENTS AND APPEARANCE
    CETIRIZINE HYDROCHLORIDE 
    cetirizine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71205-093(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
    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) Size7mm
    FlavorImprint Code CTN;5
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71205-093-1515 in 1 BOTTLE; Type 0: Not a Combination Product08/01/2018
    2NDC:71205-093-3030 in 1 BOTTLE; Type 0: Not a Combination Product08/01/2018
    3NDC:71205-093-6060 in 1 BOTTLE; Type 0: Not a Combination Product08/01/2018
    4NDC:71205-093-9090 in 1 BOTTLE; Type 0: Not a Combination Product08/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07782910/01/2009
    Labeler - Proficient Rx LP (079196022)
    Establishment
    NameAddressID/FEIBusiness Operations
    Proficient Rx LP079196022REPACK(71205-093) , RELABEL(71205-093)
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