Label: CETIRIZINE HYDROCHLORIDE tablet

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

Drug Label Information

Updated November 9, 2015

If you are a consumer or patient please visit this version.

View All Sections
  • OTC - ACTIVE INGREDIENT SECTION

    Active Ingredients (in each tablet)                                                        Purpose

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

  • OTC - PURPOSE SECTION

    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 SECTION

    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.

  • OTC - ASK DOCTOR SECTION

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

  • OTC - ASK DOCTOR/PHARMACIST SECTION

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

  • OTC - WHEN USING SECTION

    • drowsines may occur
    • avoid alcoholic drinks
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • be careful when driving a motor vehicle or operating machinary
  • INDICATIONS & USAGE SECTION

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

  • OTC - STOP USE SECTION

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

  • OTC - PREGNANCY OR BREAST FEEDING SECTION

    • if breast-feeding: not recommended
    • if pregnant: ask a health professional before use.
  • OTC - KEEP OUT OF REACH OF CHILDREN SECTION

    In case of overdose, get medical help or contact Poison Control Center right away.

  • INSTRUCTIONS FOR USE SECTION

    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 sever symptoms.
    Adults 65 years and overAsk a doctor
    Children under 6 years of ageAsk a doctor
    Consumers with liver or kidney diseaseAsk a doctor

  • DOSAGE & ADMINISTRATION SECTION

    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 sever 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 SAFETY INFORMATION

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

  • INACTIVE INGREDIENT SECTION

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

  • ​OTC - QUESTIONS SECTION

    Call 1-866-562-4597

  • SPL UNCLASSIFIED SECTION

    Manufactured for PACK Pharmaceuticals, LLC

    Buffalo Grove, IL 60089, USA

    Manufactured by Unique Pharmaceutical Laboratories (A Div. of J. B. Chemicals & Pharmaceuticals Ltd.),

    Mumbai 400 030, India

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    CETIRIZINE HYDROCHLORIDE 
    cetirizine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61919-538(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
    hypromelloses (UNII: 3NXW29V3WO)  
    lactose (UNII: J2B2A4N98G)  
    magnesium stearate (UNII: 70097M6I30)  
    starch, corn (UNII: O8232NY3SJ)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    povidone (UNII: FZ989GH94E)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeBULLETSize8mm
    FlavorImprint Code CTN;10
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61919-538-3030 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07782901/01/2014
    Labeler - DIRECT RX (079254320)
    Establishment
    NameAddressID/FEIBusiness Operations
    DIRECT RX079254320relabel(61919-538) , repack(61919-538)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!