Label: CHILDRENS 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 1, 2022

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

View All Sections
  • 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?

    call 1-855-274-4122
    DISTRIBUTED BY:
     WALGREEN CO.
    200 WILMOT RD., DEERFIELD, IL 60015

    Walgreens
    100% SATISFACTION
    GUARANTEED

    walgreens.com ©2021 Walgreen Co.

    MADE IN INDIA
    Code: TS/DRUGS/22/2009

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

    NDC 0363-4020-84
    Walgreens
    Compare to the active ingredient
    in Claritin® RediTabs®††

    Junior's
    Allergy Relief
    LORATADINE ORALLY DISINTEGRATING
    TABLETS USP 10 mg / ANTIHISTAMINE

    Dissolvable Tablet
    Non-Drowsy* 24 Hour

    • Melts in mouth with no water needed
    • 24-hour relief of sneezing, runny nose, itchy, watery eyes & itchy throat or nose
    • Indoor & outdoor allergies

    AGES 6 YEARS & OLDER

    30 ORALLY DISINTEGRATING
         TABLETS
    ACTUAL SIZE

    *WHEN TAKEN AS DIRECTED. SEE DRUG FACTS PANEL.


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





  • INGREDIENTS AND APPEARANCE
    CHILDRENS LORATADINE ODT 
    loratadine tablet, orally disintegrating
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-4020
    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 (120 .MU.M) (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:0363-4020-843 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 - WALGREEN CO. (008965063)
    Registrant - Aurohealth LLC (078728447)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aurobindo Pharma Limited650381903ANALYSIS(0363-4020) , MANUFACTURE(0363-4020)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!