Label: REXALL ALLERGY RELIEF NON DROWSY- loratadine tablet

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

Drug Label Information

Updated 08/10

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

  • Active ingredient (in each tablet)

    Loratadine 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

    Ask a doctor before use if you have

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

    When using this product

    do not take more than directed. Taking more than directed may cause drowsiness.

    Stop use and ask a doctor if

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

    If pregnant or breast-feeding,

    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 1 tablet daily; not 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
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  • Other information

    • do not use if printed foil under cap is broken or missing
    • store at 20°-25°C (68°-77°F)
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  • Inactive ingredients

    lactose monohydrate, magnesium stearate, povidone, pregelatinized starch

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  • Principal Display Panel

    Non-Drowsy*

    24 Hour

    Actual Size

    Allergy Relief

    Loratadine Tablets, 10 mg/Antihistamine

    Gluten Free

    Relief of

    Sneezing

    Itchy, watery eyes

    Runny nose

    Itchy throat or nose

    Original Prescription Strength

    Indoor & outdoor allergies

    *When taken as directed.

    See Drug Facts Panel.

    Allergy Relief Carton Image 1

    Allergy Relief Carton Image 1

    Allergy Relief Carton Image 2

    Allergy Relief Carton Image 2

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  • INGREDIENTS AND APPEARANCE
    REXALL ALLERGY RELIEF  NON DROWSY
    loratadine tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:55910-612
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE 10 mg
    Inactive Ingredients
    Ingredient Name Strength
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POVIDONE (UNII: FZ989GH94E)  
    Product Characteristics
    Color WHITE Score no score
    Shape OVAL Size 8mm
    Flavor Imprint Code L612
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:55910-612-65 1 in 1 CARTON
    1 30 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA076301 08/22/2010
    Labeler - Dolgencorp, LLC (068331990)
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