Label: CETIRIZINE HYDROCHLORIDE tablet

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

Drug Label Information

Updated March 25, 2011

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  • SPL UNCLASSIFIED SECTION

    Drug Facts:

  • Active Ingredient ( in each tablet)

    Cetirizine HCl 10 mg

  • 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 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

    • drowsiness may occur
    • avoid alcoholic drinks
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • be careful when driving a motor vehicle or operating machinery
  • Stop use and ask a doctor if

    an allergic reaction to this product occurs. Seek medical help right away.

  • If pregnant or breat-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 a Poison Control Center right away.

  • Directions

    adults and children 6 yearsand 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
  • SPL UNCLASSIFIED SECTION

    Other information

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

  • Inactive ingredients

    povidone, lactose monohydrate, corn starch, magnesium stearate, hypromelloses, titanium dioxide, polyethylene glycol, talc.

  • Questions?

    call 1-800-406-7984

  • SPL UNCLASSIFIED SECTION

    Manufactured for:

    Ohm Laboratories Inc.

    14 Terminal Road

    New Brunswick, NJ 08901

    Manufactured by:    

    Ipca Laboratories Limited

    1, Pharma Zone, SEZ Indore,

    Pithampur 454775, (M.P.), India

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Ohm Laboratories Inc.\Ranbaxy Group Company

    NDC: 57451-5067-1

    Cetirizine Hydrochloride Tablets 10 mg

    1x 10000 Tablets

    Each tablet contains:

    Cetirizine hydrochloride 10 mg

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

    Code                       :  MP/DRUGS/25/1/2008

    Batch No.           :

    Mfg. Dt.           :

    Exp. Dt.           :

    Manufactured for:

    Ohm Laboratories Inc.

    14 Terminal Road

    New Brunswick, NJ 08901

    Manufactured by:

    Ipca Laboratories Limited

    1, Pharma Zone, SEZ, Indore

    Pithampur- 454775 (M.P.), India

    10-mg
  • INGREDIENTS AND APPEARANCE
    CETIRIZINE HYDROCHLORIDE 
    cetirizine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57451-5067
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24) CETIRIZINE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    POVIDONE K30 (UNII: U725QWY32X)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeROUND (rectangular) Size9mm
    FlavorImprint Code RI52
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57451-5067-110000 in 1 POUCH
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07749812/27/2007
    Labeler - Ipca Laboratories Limited (862179827)
    Registrant - Ipca Laboratories Limited (650387009)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ipca Laboratories Limited677600550Manufacture
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