Label: LORATADINE ODT - loratadine tablet, orally disintegrating

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

Drug Label Information

Updated April 20, 2018

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

  • Drug Facts
  • 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
    • sneezing
    • itchy, watery eyes
    • 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 (1-800-222-1222) right away.

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  • Directions


    • place 1 tablet on tongue; tablet disintegrates, with or without water 

     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

    • Phenylketonurics: Contains phenylalanine 2.25 mg per tablet
    • do not use if the individual blister unit is open or torn
    • store at 20° to 25°C (68° to 77°F)
    • use tablet immediately after opening individual blister
    • Complies with USP test 2 for Disintegration
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  • Inactive ingredients

    aspartame, crospovidone, mannitol, microcrystalline cellulose,  peppermint, pregelatinized starch (maize), sodium stearyl fumarate

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  • Questions or comments?

    DISTRIBUTED BY: Walmart Inc,.
    Bentonville, AR 72716
    This Product is not manufactured or distributed
    by Bayer HealthCare LLC, distributor of claritin®RediTabs®

    Manufactured for :
    AUROHEALTH LLC
    2572 Brunswick Pikg
    Lawrenceville, NJ 08684

    Manufactured by :
    Aurobindo Pharma Limited
    Unit- VII (SEZ)
    Mahabubnagar (Dt) -509302
    India

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  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg, Blister Carton 30 (3 x 10) Orally Disintegrating Tablets

     

    NDC 49035-806-09

    equateTM

     

    Compared to
    the active        

    Ingredient

    In Claritin®

    RediTabs®**

     

    Non-Drowsy*

    Loratadine Orally                                        No Water Needed

    Disintegrating                                           Melts in Your Mouth
    Tablets USP 10 mg / Antihistamine

    Indoor & Outdoor Allergy Relief

    24 Hour Relief Of:

    • Sneezing
    • Runny nose                                            24
    • Itchy, watery eyes                                 HOUR
    • Itchy throat or nose

    Original  Prescription Strength                                                 

                                                                                             30    
    *When taken as directed. See Drug Facts Panel.     TABLETS   (310)Orally Disintegrating Tablets

    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg, Blister Carton 30 (3 x 10) Orally Disintegrating Tablets

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  • INGREDIENTS AND APPEARANCE
    LORATADINE ODT 
    loratadine tablet, orally disintegrating
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:49035-806
    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
    ASPARTAME (UNII: Z0H242BBR1)  
    CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)  
    MANNITOL (UNII: 3OWL53L36A)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    PEPPERMINT (UNII: V95R5KMY2B)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)  
    Product Characteristics
    Color WHITE (White to Off-white) Score no score
    Shape ROUND (Biconvex) Size 8mm
    Flavor PEPPERMINT Imprint Code K;9
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:49035-806-09 3 in 1 CARTON 04/11/2018
    1 10 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA208477 04/11/2018
    Labeler - Wal-Mart Stores, Inc. (051957769)
    Registrant - Aurohealth LLC (078728447)
    Establishment
    Name Address ID/FEI Business Operations
    Aurobindo Pharma Limited 650381903 ANALYSIS(49035-806) , MANUFACTURE(49035-806)
    Establishment
    Name Address ID/FEI Business Operations
    Vasudha Pharma Chem Ltd. 725431626 API MANUFACTURE(49035-806)
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