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 September 20, 2016

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.

    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
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • avoid alcoholic drinks
    •  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.  

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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 1-877-753-3935 Monday-Friday 9AM-5PM EST

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  • Principal Display Panel

    Compare to Active Ingredient in ZYRTEC®*

    Original Prescription Strength

    ALLERGY RELIEF

    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

    TABLETS

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

    TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING   

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

    Distributed by:

    Rugby Laboratories

    17177 N Laurel Park Dr., Suite 233

    Livonia, MI  48152

    www.rugbylaboratories.com

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  • Product Label

    Cetirizine HCI 10 mg

    RUGBY Allergy Relief



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  • INGREDIENTS AND APPEARANCE
    CETIRIZINE HYDROCHLORIDE 
    cetirizine hydrochloride tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0536-4088
    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
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    POVIDONE (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:0536-4088-88 1 in 1 BOX 03/23/2012
    1 14 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2 NDC:0536-4088-07 2 in 1 BOX 03/23/2012
    2 30 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3 NDC:0536-4088-11 1 in 1 BOX 03/23/2012
    3 90 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA078780 03/23/2012
    Labeler - Rugby Laboratories, Inc. (079246066)
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