LORATADINE capsule, liquid filled

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:
- 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

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
- do not use if the individual blister unit is open or torn
- store between 20° to 25°C (68° to 77°F)
- protect from freezing
- FDA approved dissolution test specifications differ from USP
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:
- Sneezing
- Runny Nose
- Itchy, Watery Eyes
- Itchy Throat or Nose
24 HOUR

10 Liquid-Filled Capsules

*When taken as directed.

See Drug Facts Panel.

INGREDIENTS AND APPEARANCE

LORATADINE
loratadine capsule, liquid filled

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN)	LORATADINE	10 mg

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC: 58602-818-83	1 in 1 CARTON	03/24/2023
1		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 58602-818-67	2 in 1 CARTON	03/24/2023
2		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC: 58602-818-84	3 in 1 CARTON	03/24/2023
3		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
4	NDC: 58602-818-08	4 in 1 CARTON	03/24/2023
4		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
5	NDC: 58602-818-05	5 in 1 CARTON	03/24/2023
5		10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA211900	03/24/2023

Labeler - Aurohealth LLC (078728447)

Name	Address	ID/FEI	Business Operations
Establishment
Aurobindo Pharma Limited		650381903	ANALYSIS(58602-818) , MANUFACTURE(58602-818)

Loratadine by