Label: CETIRIZINE HYDROCHLORIDE tablet, film coated

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

Drug Label Information

Updated December 12, 2019

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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 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 a Poison Control Center right away.

  • Directions

     adults and children 6 years and over

     Take 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
  • Other information

    •
    store between 20° and 25°C (68° - 77°F)
  • Inactive ingredients

    Lactose Monohydrate, microcrystalline cellulose, starch (corn), magnesium stearate, hypromellose, polydextrose, polyethylene glycol, and titanium dioxide.

  • Questions or comments?

    call 1-800-706-5575, weekdays, 8:30am - 5:00pm Eastern Standard Time

    Manufactured by:

    Apotex In c.

    Toronto, Ontario

    Canada M9L 1T9

    Manufactured for:

    Apotex Corp.

    Weston, Florida

    33326

    Distributed By:

    MAJOR® PHARMACEUTICALS

    31778 Enterprise Drive

    Livonia, MI 48150

  • Principal Display Panel

    Cetirizine 10 mg

    Cetirizine Hydrochloride Tablets

    Antihistamine/Original Prescription Strength

    Indoor & Outdoor Allergies

    24 hour

    Relief of

     
    • Sneezing
     
    • Runny Nose
     
    • Itchy, Watery Eyes
     
    • Itchy Throat or Nose

    Cetirizine HCl Tablets, 10 mg

    14 Tablets

    carton
  • Principal Display Panel

    Cetirizine HCl Tablets, 10 mg

    30 Tablets

    bottle label
  • Principal Display Panel

    Cetirizine HCl Tablets, 10 mg

    45 Tablets

    bottle label
  • Principal Display Panel

    Cetirizine HCl Tablets, 10 mg

    90 Tablets

    bottle label
  • Principal Display Panel

    Cetirizine HCl Tablets, 10 mg

    100 Tablets

    bottle label
  • Principal Display Panel

    Cetirizine HCl Tablets, 10 mg

    100 Tablets

    carton label
  • INGREDIENTS AND APPEARANCE
    CETIRIZINE HYDROCHLORIDE 
    cetirizine hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-5852(NDC:60505-2633)
    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
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    POLYDEXTROSE (UNII: VH2XOU12IE)  
    POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeRECTANGLE (pillow-shaped) Size9mm
    FlavorImprint Code 10MG;APO
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0904-5852-4114 in 1 CARTON12/27/200702/29/2020
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:0904-5852-4345 in 1 BOTTLE; Type 0: Not a Combination Product12/27/2007
    3NDC:0904-5852-4630 in 1 BOTTLE; Type 0: Not a Combination Product12/27/2007
    4NDC:0904-5852-60100 in 1 BOTTLE; Type 0: Not a Combination Product12/27/2007
    5NDC:0904-5852-8990 in 1 BOTTLE; Type 0: Not a Combination Product12/27/2007
    6NDC:0904-5852-61100 in 1 CARTON12/27/200702/29/2020
    61 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07831712/27/2007
    Labeler - Major Pharmaceuticals (191427277)
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