Label: LORATADINE- loratadine tablet

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

Drug Label Information

Updated November 4, 2015

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.

    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

    Safety sealed: do not use if the imprinted bottle seal is open or torn (for bottle only).
    Safety sealed: do not use if open or torn (for blister package only).

    Store at 20°-25°C (68°-77°F) (see USP Controlled Room Temperature).
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  • Inactive Ingredients

    Lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate.

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  • Questions or comments?

    1-800-525-8747

    10-2015M

    Sandoz Inc.

    Princeton, NJ 08540

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  • 10 mg Label

    Loratadine 10 mg Label

    NDC 0781-5077-01 Non-Drowsy*

    Loratadine

    Tablets, USP

    10 mg

    Antihistamine

    Indoor & Outdoor Allergies

    100 Tablets

    SANDOZ

    24 Hour

    Relief of:

    Sneezing

    Runny Nose

    Itchy, Watery

    Eyes

    Itchy Throat

    or Nose

    * When taken as directed.

    See Drug Facts Panel.

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  • INGREDIENTS AND APPEARANCE
    LORATADINE 
    loratadine tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0781-5077
    Route of Administration ORAL
    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)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    Product Characteristics
    Color WHITE (white to off white) Score no score
    Shape ROUND Size 6mm
    Flavor Imprint Code GG296
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0781-5077-01 100 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA075209 01/21/2003
    Labeler - Sandoz Inc (110342024)
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