Label: CETIRIZINE HYDROCHLORIDE tablet

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

Drug Label Information

Updated September 18, 2019

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  • Active Ingredients

    Cetirizine HCl 10 mg..............................................................................................Antihistimine Active Ingredients (in each tablet)                                                        Purpose

  • PURPOSE

    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

    if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine. Do Not Use

  • ASK DOCTOR

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

  • ASK DOCTOR/PHARMACIST

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

  • 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

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

  • 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 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
  • Inactive Ingredients

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

  • 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

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    CETIRIZINE HYDROCHLORIDE 
    cetirizine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55700-331(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, 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:55700-331-3030 in 1 BOTTLE; Type 0: Not a Combination Product07/24/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07782910/01/2009
    Labeler - Lake Erie Medical DBA Quality Care Products LLC (831276758)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lake Erie Medical DBA Quality Care Products LLC831276758repack(55700-331)
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