LORATADINE- loratadine oral solution

Loratadine by

Drug Labeling and Warnings

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

Drug Details [pdf]

Drug Facts

Active ingredient (in each 5 mL)

Loratadine USP 5 mg

Purpose

Antihistamine

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

• runny nose
• itchy, watery eyes
• sneezing
• 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
• mL= milliliter

• adults and children 6 years and over: 10mL daily; do not take more than 10mL in 24 hours
• children 2 to under 6 years of age: 5mL daily; do not take more than 5mL in 24 hours
• children under 2 years of age: ask a doctor
• consumers with liver or kidney disease: ask a doctor

Other information

• each 5mLcontains: 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



Manufactured by:

Aurobindo Pharma Limited

Hyderabad-500 090, India

For BluePoint Laboratories

Code:TS/DRUGS/19/1993

Revised: 04/2025

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 5 mg/5 mL (120 mL Bottle)

NDC: 68001-449-98



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



4FL OZ (120 mL)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 5 mg/5 mL Carton (120 mL)

NDC: 68001-449-98

#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
• Sugar-Free
• Alcohol Free

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

* When taken as directed.

See Drug Facts Panel.



Grape

Flavor



4 FL OZ (120 mL)

INGREDIENTS AND APPEARANCE

LORATADINE 
loratadine oral solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68001-449
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: 68001-449-98	1 in 1 CARTON	07/31/2020
1		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	07/31/2020

Labeler - BluePoint Laboratories (985523874)

Establishment
Name	Address	ID/FEI	Business Operations
Aurobindo Pharma Limited		918917642	analysis(68001-449) , manufacture(68001-449)