LORATADINE ODT - loratadine tablet, orally disintegrating 
Aurohealth LLC

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Loratadine Orally Disintegrating Tablets USP 10 mg

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:

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

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
279 Princeton-Hightstown Road
East Windsor, NJ 08520

Made in India

Code: TS/DRUGS/22/2009

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg, Blister Carton 60 (6 X 10) Orally Disintegrating Tablets

Healthy LivingTM

Original Prescription Strength        *When taken as directed. See Drug Facts Panel.

LORATADINE
orally disintegrating tablets USP 10 mg

Antihistamine
Non-Drowsy
Indoor & Outdoor Allergies

Compare
to the Active
Ingredient in
Claritin®
RediTabs®

24 Hour                                                                     ACTUAL SIZE
                                                                                      60 (6 X 10)
• Relief of sneezing, runny nose, itchy,
  watery eyes & itchy throat or nose                        Orally Disintegrating
• No water needed — melts in your mouth                        Tablets
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg, Blister Carton 60 (6 X 10) Orally Disintegrating Tablets

LORATADINE ODT 
loratadine tablet, orally disintegrating
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-881
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:58602-881-156 in 1 CARTON06/18/2022
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20847706/18/2022
Labeler - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
Aurobindo Pharma Limited650381903ANALYSIS(58602-881) , MANUFACTURE(58602-881)

Revised: 6/2022
Document Id: a6e04fe7-23d3-47d7-9f18-5c4298fbc28b
Set id: a6e04fe7-23d3-47d7-9f18-5c4298fbc28b
Version: 1
Effective Time: 20220620
 
Aurohealth LLC