LORATADINE- loratadine oral solution 
BluePoint Laboratories

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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



Manufactured by:

Aurobindo Pharma Limited

Hyderabad-500 090,

India

For BluePoint Laboratories



Made in India


Code:TS/DRUGS/19/1993

Issued: 06/2020

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:

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



4FL OZ (120 mL)

Loratadine OS Label

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:

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



4 FL OZ (120 mL)

Loratadine OS Carton





LORATADINE 
loratadine oral solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68001-449
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:68001-449-981 in 1 CARTON07/31/2020
1120 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20893107/31/2020
Labeler - BluePoint Laboratories (985523874)
Establishment
NameAddressID/FEIBusiness Operations
Aurobindo Pharma Limited918917642analysis(68001-449) , manufacture(68001-449)

Revised: 7/2020
Document Id: ab820f80-b5fd-7896-e053-2995a90a4b1c
Set id: ab820f80-b5fc-7896-e053-2995a90a4b1c
Version: 1
Effective Time: 20200731
 
BluePoint Laboratories