Label: LORATADINE- loratadine tablet

  • NDC Code(s): 53329-651-33, 53329-651-38
  • Packager: Medline Industries, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated 03/13

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.

    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

    • store between 20 and 25° C (68 and 77° F)
    • protect from excessive moisture
    • TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.
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  • INACTIVE INGREDIENTS

    Corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch

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  • QUESTIONS?

    Call 1-800-MEDLINE (633-5463), Monday - Friday, 9AM - 5PM CST

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  • PRINCIPAL DISPLAY PANEL

    MEDLINE

    NDC 53329-651-33

    Compare to the active ingredient in Claritin®

    NON-DROWSY*

    LORATADINE TABLETS, USP 10 mg

    ANTIHISTAMINE

    ALLERGY RELIEF

    Indoor & Outdoor Allergies

    24 HOUR RELIEF of:

    Sneezing

    Runny Nose

    Itchy, Watery Eyes

    • Itchy Throat or Nose

    10 mg

    30 Tablets

    (When taken as directed. See Drug Facts Panel.)

    Distributed by: Medline, Industries, Inc.

    5099016/1012

    30's bottle label
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  • INGREDIENTS AND APPEARANCE
    LORATADINE 
    loratadine tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:53329-651
    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
    STARCH, CORN (UNII: O8232NY3SJ)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    Color white (White to Off-White) Score no score
    Shape ROUND Size 6mm
    Flavor Imprint Code RX526
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:53329-651-33 30 in 1 BOTTLE
    2 NDC:53329-651-38 90 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA076134 08/19/2003
    Labeler - Medline Industries, Inc. (025460908)
    Registrant - Ranbaxy Pharmaceuticals Inc. (937890044)
    Establishment
    Name Address ID/FEI Business Operations
    Ohm Laboratories Inc. 051565745 manufacture(53329-651)
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