LORATADINE - loratadine tablet 
Aurohealth LLC

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Loratadine 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

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

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 (150 Tablets Bottle)

Healthy Living™

LORATADINE                                
tablets USP 10 mg

Antihistamine
Indoor & Outdoor Allergies
Non-Drowsy*
 

24 Hour 

Relief of:  • Sneezing  •Runny Nose
•Itchy, Watery Eyes  •
Itchy Throat or Nose           
      
 *When taken as directed. See Drug Facts Panel.         150  Tablets


PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (90 Tablets Bottle)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg Container Carton (150 Tablets)

Healthy Living™

LORATADINE                                 *When taken as directed. See Drug Facts Panel.
tablets USP 10 mg

Antihistamine
Indoor & Outdoor Allergies
Non-Drowsy*
 

#Compare
to the Active

Ingredient in
Claritin®


24 Hour 

Relief of:  • Sneezing  •Runny Nose
•Itchy, Watery Eyes  •Itchy Throat or Nose                 150  Tablets
  


PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg Container Carton (90 Tablets)
LORATADINE 
loratadine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-847
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:58602-847-191 in 1 CARTON05/16/2020
190 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:58602-847-291 in 1 CARTON08/13/2020
2150 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20831405/16/2020
Labeler - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
Aurobindo Pharma Limited650381903ANALYSIS(58602-847) , MANUFACTURE(58602-847)

Revised: 6/2022
Document Id: e24be27d-9c5e-4ff5-ae6d-96a6c1b6e710
Set id: c6bfb54a-04d8-41c1-9fa9-5d4bae0a66d1
Version: 4
Effective Time: 20220618
 
Aurohealth LLC