Label: LORATADINE tablet

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

Drug Label Information

Updated November 4, 2022

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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                                                                    
    • itchy, watery eyes
    • sneezing 
    • 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

    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


    • safety sealed: do not use if the individual blister unit is open or torn
    • store at 20° to 25°C (68° to 77°F)
    • protect from excessive moisture
  • Inactive ingredients

    lactose monohydrate, magnesium stearate, pregelatinized starch (maize), sodium starch glycolate.

  • Questions or comments?


    call 1-855-274-4122

    Distributed by:
    Consumer Value Products, Inc.
    PO Box 6115, Temple Texas 76502
    CVPproducts.com

    Made in India
    Code: TS/DRUGS/22/2009


  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg Blister Carton (10 Tablets)

    NDC 57243-200-69
    COMPARE TO
    THE ACTIVE INGREDIENT
    IN CLARITIN®
    CVP HEALTH
    NON-DROWSY*  . 24 Hour
    ALLERGY RELIEF
    LORATADINE TABLETS USP 10 mg
    ANTIHISTAMINE
    INDOOR & OUTDOOR
    ALLERGIES

    RELIEF OF:

     SNEEZING
     RUNNY NOSE
     ITCHY, WATERY EYES
     ITCHY THROAT OR NOSE

    10 Tablets

    *When taken as directed. See Drug Facts Panel.
    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg Blister Carton (10 Tablets)
     

  • INGREDIENTS AND APPEARANCE
    LORATADINE 
    loratadine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57243-200
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    Product Characteristics
    ColorWHITE (White to Off-white) Scoreno score
    ShapeROUNDSize6mm
    FlavorImprint Code 39;L
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57243-200-691 in 1 CARTON04/16/2018
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20831404/16/2018
    Labeler - McLane Company, Inc. (009830555)
    Registrant - Aurohealth LLC (078728447)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aurobindo Pharma Limited650381903ANALYSIS(57243-200) , MANUFACTURE(57243-200)
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