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

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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 LABEL Item Code (Source) NDC:0536-4088
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CETIRIZINE HYDROCHLORIDE (CETIRIZINE) CETIRIZINE HYDROCHLORIDE 10 mg
    Inactive Ingredients
    Ingredient Name Strength
    LACTOSE MONOHYDRATE  
    MAGNESIUM STEARATE  
    POLYVINYL ALCOHOL  
    POLYETHYLENE GLYCOLS  
    POVIDONES  
    STARCH, CORN  
    TALC  
    TITANIUM DIOXIDE  
    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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