LORATADINE - loratadine capsule, liquid filled 
Aurohealth LLC

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Drug Facts

Active ingredient

 (in each capsule)

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 capsule daily; not more than 1 capsule 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

Gelatin, glycerin, glyceryl monocaprylocaprate, hypromellose, isopropyl alcohol, Neelicert FD&C Blue No.1, polysorbate 80, povidone, propylene glycol, purified water, sorbitol sorbitan solution and titanium dioxide.

Questions or comments?

 call 1-855-274-4122 (Monday – Friday 8:30 AM to 5:00 PM EST)

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 (10 Capsule Blister Carton)

AUROHEALTH

NDC 58602-818-83

Compare to the active ingredient

in Claritin® Liqui-Gels®†

Non-Drowsy*

Loratadine Capsules USP 10 mg

Antihistamine

Indoor & Outdoor Allergies

Relief of:

24 HOUR

10 Liquid-Filled Capsules

*When taken as directed.

See Drug Facts Panel.

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

LORATADINE 
loratadine capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-818
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE10 mg
Inactive Ingredients
Ingredient NameStrength
GELATIN TYPE B BOVINE (160 BLOOM) (UNII: 1T8387508X)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL MONO AND DICAPRYLOCAPRATE (UNII: U72Q2I8C85)  
HYPROMELLOSE 2910 (3 MPA.S) (UNII: 0VUT3PMY82)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
POVIDONE K30 (UNII: U725QWY32X)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorBLUEScoreno score
ShapeOVALSize11mm
FlavorImprint Code LR10
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58602-818-831 in 1 CARTON03/24/2023
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:58602-818-672 in 1 CARTON03/24/2023
210 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:58602-818-843 in 1 CARTON03/24/2023
310 in 1 BLISTER PACK; Type 0: Not a Combination Product
4NDC:58602-818-084 in 1 CARTON03/24/2023
410 in 1 BLISTER PACK; Type 0: Not a Combination Product
5NDC:58602-818-055 in 1 CARTON03/24/2023
510 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21190003/24/2023
Labeler - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
Aurobindo Pharma Limited650381903ANALYSIS(58602-818) , MANUFACTURE(58602-818)

Revised: 3/2023
Document Id: a057241d-a655-4847-9d2d-d45293f45d87
Set id: a057241d-a655-4847-9d2d-d45293f45d87
Version: 1
Effective Time: 20230324
 
Aurohealth LLC