Label: CETIRIZINE HYDROCHLORIDE- cetirizine hydrochloride tablet

  • NDC Code(s): 0536-4088-07, 0536-4088-11, 0536-4088-88
  • Packager: Rugby Laboratories Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated 04/13

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

  • Active Ingredient (in each tablet)

    Cetirizine HCl 10 mg

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  • Purpose

    Antihistamine

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  • 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

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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.

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  • Ask a doctor before use if you have

     liver or kidney disease. Your doctor should determine if you need a different dose.

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  • Ask a doctor or pharmacist before use if you are

     taking tranquilizers or sedatives.

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  • 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

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  • Stop use and ask a doctor if

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

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  • 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.

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  • 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
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  • Other Information

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

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  • Inactive Ingredients

    lactose monohydrate, magnesium stearate, polyvinyl alcohol, polyethylene glycol, povidone, starch, talc, titanium dioxide.

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  • Questions or comments?

    Call 1-800-645-2158, 9am-5pm ET. Monday-Friday

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  • Principal Display Panel

    Compare to Active Ingredient in ZYRTEC®*

    Original Prescription Strength

    CETIRIZINE HYDROCHLORIDE TABLETS, 10 mg

    ANTIHISTAMINE

    ALLERGY

    Indoor and Outdoor Allergies

    24 hour relief of:

    • Runny nose
    • Sneezing
    • Itchy, watery eyes
    • Itchy throat or nose

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

    THIS PRODUCT IS PACKAGED IN A CHILD RESISTANT AND TAMPER EVIDENT PACKAGE. USE ONLY IF BLISTERS ARE INTACT.

    *Rugby Laboratories is not affiliated with the owner of the trademark Zyrtec®.

    Distributed by: Rugby Laboratories

    31778 Enterprise Drive

    Livonia, MI  48150

    www.rugbylaboratories.com

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  • Product Label

    Cetirizine 10 mg

    Rugby Cetirizine 10 mg Allergy Tablet



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  • INGREDIENTS AND APPEARANCE
    CETIRIZINE HYDROCHLORIDE 
    cetirizine tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0536-4088
    Route of Administration ORAL DEA Schedule     
    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
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYVINYL ALCOHOL (UNII: 532B59J990)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    POVIDONES (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Color WHITE (white) Score no score
    Shape OVAL (oval) Size 8mm
    Flavor Imprint Code IP;46
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0536-4088-11 4 in 1 BOX
    1 90 in 1 BLISTER PACK
    2 NDC:0536-4088-88 1 in 1 BOX
    2 14 in 1 BLISTER PACK
    3 NDC:0536-4088-07 2 in 1 BOX
    3 30 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA078780 03/23/2012
    Labeler - Rugby Laboratories Inc (191427277)
    Registrant - P and L Development of New York Corporation (800014821)
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