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 June 11, 2019

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  • Drug Facts

  • Active ingredient (in each tablet)

    Loratadine USP 10 mg

  • Purpose

    Antihistamine

  • 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
  • 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 (1-800-222-1222) right away.

  • 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
  • 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
  • Inactive ingredients

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

  • Questions or comments?

    1-888-287-1915

  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg, Blister Carton 10 (1 x 10) Orally Disintegrating Tablets

    NDC 49035-806-03
    equateTM
    Compare to Claritin® RediTabs® active Ingredient**
    Children's Non-Drowsy*
    LORATADINE ORALLY
    DISINTEGRATING
    Tablets USP 10 mg
    Antihistamine
    FOR CHILDREN SIX YEARS OF AGE OR OLDER
    Indoor & Outdoor
    Allergies
    LASTS UP TO
    24 HOURS
    Relief of:
    Sneezing
    Runny Nose                                           Dissolves in
    Itchy, Watery Eyes                               Your Mouth
    Itchy Throat or Nose
    *When taken as directed.                     Original
    See Drug Facts Panel.                          Prescription Strength
    10 (1X10) Orally Disintegrating Tablets
    figure1

  • INGREDIENTS AND APPEARANCE
    LORATADINE ODT 
    loratadine tablet, orally disintegrating
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-806
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    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
    ColorWHITE (White to Off-white) Scoreno score
    ShapeROUND (Biconvex) Size8mm
    FlavorPEPPERMINTImprint Code K;9
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49035-806-031 in 1 CARTON04/11/2018
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20847704/11/2018
    Labeler - Wal-Mart Stores, Inc. (051957769)
    Registrant - Aurohealth LLC (078728447)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vasudha Pharma Chem Ltd.725431626API MANUFACTURE(49035-806)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aurobindo Pharma Limited650381903ANALYSIS(49035-806) , MANUFACTURE(49035-806)
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