Label: LORATADINE ODT- loratadine tablet, orally disintegrating

  • NDC Code(s): 58602-821-83, 58602-821-84
  • Packager: Aurohealth LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated November 3, 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:

    AUROHEALTH LLC

    2572 Brunswick Pike

    Lawrenceville, NJ 08648

    Made in India

    Code: TS/DRUGS/22/2009

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

    NDC 58602-821-83

    PrimaryHEALTH

    COMPARE TO Claritin℗ RediTabs℗Active ingredient**
    Non-Drowsy*
    Allergy Relief
    Loratadine Orally Disintegrating Tablets USP 10 mg
    Antihistamine
    Indoor & Outdoor Allergies
    Original Prescription Strength

    24 HOUR
    Relief of:
    • Sneezing
    • Runny Nose
    • Itchy, Watery Eyes
    • Itchy Throat or Nose

    No Water Needed
    Melts in Your Mouth

    *When taken as directed. See Drug Facts Panel.

    10 Orally Disintegrating Tablets


    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg, Blister Carton (10 Orally Disintegrating Tablets)
  • INGREDIENTS AND APPEARANCE
    LORATADINE ODT 
    loratadine tablet, orally disintegrating
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-821
    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:58602-821-831 in 1 CARTON04/11/2018
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:58602-821-843 in 1 CARTON04/11/2018
    210 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 - Aurohealth LLC (078728447)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aurobindo Pharma Limited650381903ANALYSIS(58602-821) , MANUFACTURE(58602-821)
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!