LORATADINE - loratadine oral solution 
Aurohealth LLC

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Loratadine Oral Solution USP 5 mg/5 mL

Drug Facts

Active ingredient (in each 5 mL teaspoonful)
Loratadine USP 5 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
2 teaspoonfuls (tsp) daily; do not take more than 2 teaspoonfuls (tsp) in 24 hours 
children 2 to under 6 years of age
1 teaspoonful (tsp) daily; do not take more than 1 teaspoonful (tsp) in 24 hours
children under 2 years of age
ask a doctor
consumers with liver or kidney disease
ask a doctor

Other information

Inactive ingredients

artificial flavors, ascorbic acid, glycerin, maltitol, monobasic sodium phosphate monohydrate, phosphoric acid, propylene glycol, purified water, sodium benzoate, sodium metabisulfite, sorbitol, sucralose.

Questions or comments?

Call 1-855-274-4122

Distributed by:
AUROHEALTH LLC
2572 Brunswick Pike
Lawrenceville, NJ 08648

Made in India

 Code:TS/DRUGS/19/1993





PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 5 mg/5 mL  (60 mL Bottle)

NDC 58602-423-11

Ages
2 years
and older

Loratadine
Oral Solution USP
5 mg/5 mL

Antihistamine
 Non-Drowsy*

24 Hour Relief of:

Do not use if carton is opened,
or if cap safety seal is broken
 or missing.

Indoor & Outdoor Allergies 


Contains sodium metabisulfite,
a sulfite that may cause
allergic-type reactions.



* When taken as directed. See Drug Facts Panel.

Grape
Flavor

2 FL OZ (60 mL)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 5 mg/5 mL  (60 mL Bottle)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 5 mg/5 mL Carton (60 mL)

NDC 58602-423-11

#Compare to the
 active ingredient in
children’s Claritin®


Ages 
 

2years
and older

Loratadine
Oral Solution USP
5 mg/5 mL

Antihistamine

Non-Drowsy*

24 Hour Relief of:


   


Indoor & Outdoor Allergies

Dosing Cup Included



Contains sodium
metabisulfite, a sulfite
that may cause
allergic-type reactions.


 * When taken as directed.

See Drug Facts Panel.

Grape

 Flavor

 2 FL OZ (60 mL)


PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 5 mg/5 mL Carton (60 mL)


LORATADINE 
loratadine oral solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-423
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
GRAPE (UNII: 6X543N684K)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
MALTITOL (UNII: D65DG142WK)  
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)  
PHOSPHORIC ACID (UNII: E4GA8884NN)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Product Characteristics
ColorYELLOW (colorless to light yellow) Score    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58602-423-111 in 1 CARTON06/29/2018
160 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
2NDC:58602-423-241 in 1 CARTON06/29/2018
2120 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20893106/29/2018
Labeler - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
Aurobindo Pharma Limited918917642ANALYSIS(58602-423) , MANUFACTURE(58602-423)

Revised: 10/2022
Document Id: 3a36de14-2887-45e9-acc0-608fb1f73157
Set id: 0b86a9fe-db7e-470a-a8fa-d7d4373116ba
Version: 5
Effective Time: 20221031
 
Aurohealth LLC