Label: LORATADINE- loratadine tablet

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

Drug Label Information

Updated 03/14

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

  • USES

    temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

    • runny nosesneezing
    • itchy, watery eyes
    • itching of the nose or throat
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  • ACTIVE INGREDIENT IN EACH TABLET

    Loratadine 10 mg

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  • PURPOSE

    Antihistamine

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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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  • DOSAGE & ADMINISTRATION

    Directions

    image description

    Other information

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

    Questions or comments?

    1-800-719-9260

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  • INACTIVE INGREDIENTS

    Inactive ingredients

    lactose monohydrate, magnesium stearate, povidone, pregelatinized starch

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  • KEEP OUT OF REACH OF CHILDREN
  • PRINCIPAL DISPLAY PANEL

    Compare to Claritin® active ingredient

    Loratadine Tablets, 10 mg

    Antihistamine

    24 Hour

    Relief of:

    Sneezing

    Runny Nose

    Itchy, Watery Eyes

    Itchy Throat or Nose

    Indoor & Outdoor Allergies

    Non-Drowsy*

    *When taken as directed. See Drug Facts Panel.

    10mg Label Image:

    image description

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  • INGREDIENTS AND APPEARANCE
    LORATADINE 
    loratadine tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:61919-142(NDC:45802-650)
    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)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    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:61919-142-10 10 in 1 BOTTLE
    1 NDC:61919-142-30 30 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA076301 01/01/2014
    Labeler - DIRECT RX (079254320)
    Establishment
    Name Address ID/FEI Business Operations
    DIRECT RX 079254320 repack(61919-142) , relabel(61919-142)
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