Label: LORATADINE- loratadine tablet 

  • Label RSS
  • NDC Code(s): 0378-8880-10, 0378-8880-93
  • Packager: Mylan Pharmaceuticals Inc.
  • 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 11/13

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

  • Active ingredient

    (in each tablet)

    Loratadine USP, 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
    itchy, watery eyes
    sneezing
    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.

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  • Ask a doctor before use if you have

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

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  • When using this product

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

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  • Stop use and ask a doctor if

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

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  • If pregnant or breast-feeding,

    ask a health professional before use.

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  • 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 of kidney disease

    ask a doctor

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  • Other information

    Tamper Evident: do not use if foil seal under cap is missing, open or broken.
    store between 20° to 25°C (68° to 77°F)
    protect from excessive moisture
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  • Inactive ingredients

    Corn starch, lactose monohydrate and magnesium stearate.

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  • Questions or comments?

    call 1-877-446-3679 (1-877-4-INFO-RX)

    Manufactured for:
    Mylan Pharmaceuticals Inc.
    Morgantown, WV 26505 U.S.A.

    Made in India
    Code No.: MH/DRUGS/25/NKD/89

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  • PRINCIPAL DISPLAY PANEL

    PRODUCT PACKAGING

    NDC 0378-8880-93

    Original Prescription Strength

    Non-Drowsy*

    Loratadine
    Tablets USP, 10 mg

    Antihistamine

    Indoor and Outdoor Allergies

    24 Hour Relief of:

    Sneezing
    Runny Nose
    Itchy, Watery Eyes
    Itchy Throat or Nose

    *When taken as directed. See Drug Facts Panel.

    RMX8880H1

    30 Tablets

    Loratadine Tablets 10 mg Bottles Front First Layer
    Loratadine Tablets 10 mg Bottles Back of Front Layer
    Loratadine Tablets 10 mg Bottles Second Layer
    Loratadine Tablets 10 mg Bottles Back of Second Layer
    Loratadine Tablets 10 mg Bottles Back of Front Layer
    Loratadine Tablets 10 mg Bottles Front Layer
    Loratadine Tablets 10 mg Bottles Second Front Layer
    Loratadine Tablets 10 mg Bottles Base Layer
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  • INGREDIENTS AND APPEARANCE
    LORATADINE 
    loratadine tablet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0378-8880
    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
    STARCH, CORN  
    LACTOSE MONOHYDRATE  
    MAGNESIUM STEARATE  
    Product Characteristics
    Color WHITE (white to off-white) Score no score
    Shape ROUND Size 6mm
    Flavor Imprint Code G;L;10
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0378-8880-93 30 in 1 BOTTLE, PLASTIC
    2 NDC:0378-8880-10 1000 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA076154 03/27/2013
    Labeler - Mylan Pharmaceuticals Inc. (059295980)
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