Label: CETIRIZINE HYDROCHLORIDE- cetirizine hydrochloride tablet, film coated

  • NDC Code(s): 29300-133-00, 29300-133-01, 29300-133-05, 29300-133-13, view more
    29300-133-19, 29300-133-45, 29300-133-75, 29300-133-99, 29300-134-00, 29300-134-01, 29300-134-05, 29300-134-10, 29300-134-13, 29300-134-19, 29300-134-45, 29300-134-50, 29300-134-75, 29300-134-99
  • Packager: Unichem Pharmaceuticals (USA), Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated May 10, 2018

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

  • SPL UNCLASSIFIED SECTION

    DRUG FACTS

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  • ACTIVE INGREDIENT

    (IN EACH TABLET)

    For 5 mg

    Cetirizine Hydrochloride USP, 5 mg

    For 10 mg

    Cetirizine Hydrochloride USP, 10 mg

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  • PURPOSE

    Antihistamine

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  • INDICATIONS AND USAGE

    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
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  • 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.
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  • KEEP OUT OF REACH OF CHILDREN

    In case of overdose, get medical help or contact a Poison Control Center right away.(1-800-222-1222)

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  • DOSAGE AND ADMINISTRATION

    For 5 mg

    adults and children 6 years 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

    For 10 mg

    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 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
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  • STORAGE AND HANDLING

    • store between 20oto 25oC (68o to 77oF)
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  • INACTIVE INGREDIENT

    corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone and titanium dioxide

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  • QUESTIONS

    call 1-866-562-4616 from Monday to Friday between 8.00 Am to 8.00 PM, EST

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  • SPL UNCLASSIFIED SECTION

    Manufactured by:

    UNICHEM LABORATORIES LTD.

    Pilerne Ind. Estate, Pilerne, Bardez, Goa 403 511, India.

    Manufactured for:

    Company Logo

    Hasbrouck Heights, NJ 07604.

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  • PRINCIPAL DISPLAY PANEL
  • INGREDIENTS AND APPEARANCE
    CETIRIZINE HYDROCHLORIDE 
    cetirizine hydrochloride tablet, film coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:29300-133
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24) CETIRIZINE HYDROCHLORIDE 5 mg
    Inactive Ingredients
    Ingredient Name Strength
    HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Color WHITE Score no score
    Shape RECTANGLE (Rounded-off) Size 7mm
    Flavor Imprint Code U;133
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:29300-133-13 30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/01/2018
    2 NDC:29300-133-45 45 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/01/2018
    3 NDC:29300-133-75 75 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/01/2018
    4 NDC:29300-133-19 90 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/01/2018
    5 NDC:29300-133-01 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/01/2018
    6 NDC:29300-133-05 500 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/01/2018
    7 NDC:29300-133-99 66500 in 1 DRUM; Type 0: Not a Combination Product 06/01/2018
    8 NDC:29300-133-00 200000 in 1 DRUM; Type 0: Not a Combination Product 06/01/2018
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA078680 06/26/2009
    CETIRIZINE HYDROCHLORIDE 
    cetirizine hydrochloride tablet, film coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:29300-134
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24) CETIRIZINE HYDROCHLORIDE 10 mg
    Inactive Ingredients
    Ingredient Name Strength
    HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Color WHITE Score no score
    Shape RECTANGLE (Rounded Off) Size 9mm
    Flavor Imprint Code U;134
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:29300-134-13 30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/01/2018
    2 NDC:29300-134-45 45 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/01/2018
    3 NDC:29300-134-75 75 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/01/2018
    4 NDC:29300-134-19 90 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/01/2018
    5 NDC:29300-134-01 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/01/2018
    6 NDC:29300-134-05 500 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/01/2018
    7 NDC:29300-134-10 1000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/01/2018
    8 NDC:29300-134-50 5000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/01/2018
    9 NDC:29300-134-99 35700 in 1 DRUM; Type 0: Not a Combination Product 06/01/2018
    10 NDC:29300-134-00 100000 in 1 DRUM; Type 0: Not a Combination Product 06/01/2018
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA078680 06/26/2009
    Labeler - Unichem Pharmaceuticals (USA), Inc. (181620514)
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