LORATADINE- loratadine oral solution

Loratadine by

Drug Labeling and Warnings

Loratadine by is a Otc medication manufactured, distributed, or labeled by Aurohealth LLC, Aurobindo Pharma Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

• 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

• use only with enclosed dosing cup

• 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

• each teaspoonful contains: sodium 6 mg
• do not use if carton is opened, or if cap safety seal is broken or missing.
• store at 20° to 25°C (68° to 77°F)

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:

• Sneezing
• Runny Nose
• Itchy, Watery Eyes
• Itchy Throat or Nose

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

• Dye-Free
• Sugar-Free
• Alcohol Free 

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 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:

• Sneezing
• Runny Nose
• Itchy,watery Eyes
• Itchy Throat or Nose

   

Indoor & Outdoor Allergies

Dosing Cup Included

• Dye-Free

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)

INGREDIENTS AND APPEARANCE

LORATADINE 
loratadine oral solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58602-423
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN)	LORATADINE	5 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	YELLOW (colorless to light yellow)	Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58602-423-11	1 in 1 CARTON	06/29/2018
1		60 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
2	NDC: 58602-423-24	1 in 1 CARTON	06/29/2018
2		120 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA208931	06/29/2018

Labeler - Aurohealth LLC (078728447)

Establishment
Name	Address	ID/FEI	Business Operations
Aurobindo Pharma Limited		918917642	ANALYSIS(58602-423) , MANUFACTURE(58602-423)