Label: ALL DAY ALLERGY RELIEF- cetirizine hydrochloride tablet

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

Drug Label Information

Updated 04/14

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 20º to 25ºC (68º to 77ºF)
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  • Inactive ingredients

    lactose monohydrate, magnesium stearate, polyethylene glycol, polyvinyl alcohol,  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 the active ingredient in Zyrtec®†

    all day

    allergy relief

    cetirizine HCl tablets 10 mg

    antihistamine

    treats indoor & outdoor allergies

    original prescription strength

    24 hour relief of:

    • sneezing
    • itchy, watery eyes
    • runny nose
    • itchy throat or nose

    tablets

    †This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Zyrtec®.

    Distributed by:

    PL Developments

    200 Hicks Street

    Westbury, NY 11590

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

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

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  • Package Labeling

    Cetirizine HCl 10 mg

    ReadyInCase All Day Allergy Relief Tablet

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  • INGREDIENTS AND APPEARANCE
    ALL DAY ALLERGY RELIEF 
    cetirizine hcl tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:59726-129(NDC:65162-046)
    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)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    POVIDONES (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POLYVINYL ALCOHOL (UNII: 532B59J990)  
    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:59726-129-14 1 in 1 CARTON
    1 14 in 1 BLISTER PACK
    2 NDC:59726-129-05 1 in 1 CARTON
    2 5 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA078780 09/01/2010
    Labeler - P and L Development of New York Corporation (ReadyInCase) (800014821)
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