Label: LORATADINE- loratadine tablet

  • 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 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 LABEL 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 (LORATADINE) LORATADINE 10 mg
    Inactive Ingredients
    Ingredient Name Strength
    LACTOSE MONOHYDRATE  
    MAGNESIUM STEARATE  
    POVIDONE  
    STARCH, CORN  
    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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