CLARITIN - loratadine solution 
Schering-Plough HealthCare Products, Inc.

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CHILDREN'S CLARITIN –loratadine

Active ingredient (in each 5 mL teaspoonful)

Loratadine 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 right away.

Directions

Use only with enclosed dosing cup

Other information

Inactive ingredients

edetate disodium, flavor, glycerin, maltitol, monobasic sodium phosphate, phosphoric acid, propylene glycol, sodium benzoate, sorbitol, sucralose, purified water

Questions or comments?

1-800-CLARITIN (1-800-252-7484) or www.claritin.com

PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton

NDC 11523-7197-1

Dye-Free

ages
2 years
and older®

Children's
Claritin®

Allergy

loratadine oral solution
5 mg/5 mL-antihistamine

Non-Drowsy*

24 Hour Relief of:

Indoor & Outdoor
Allergies

DYE-FREE

4 FL OZ
(120 ml)

Grape
Taste

*When taken as directed.
See Drug Facts Panel.

PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton

CLARITIN 
loratadine   solution
Product Information
Product Type HUMAN OTC DRUG NDC Product Code (Source) 11523-7197
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Loratadine (Loratadine) Loratadine 5 mg  in 5 mL
Inactive Ingredients
Ingredient Name Strength
propylene glycol  
glycerin  
edetate disodium  
sodium benzoate  
phosphoric acid  
sodium phosphate, monobasic  
sorbitol  
sucralose  
maltitol  
water  
Product Characteristics
Color      Score     
Shape Size
Flavor GRAPE Imprint Code
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 11523-7197-1 1 BOTTLE In 1 CARTON contains a BOTTLE
1 120 mL In 1 BOTTLE This package is contained within the CARTON (11523-7197-1)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020641 03/01/2011

Labeler - Schering-Plough HealthCare Products, Inc. (039137567)
Establishment
Name Address ID/FEI Operations
Schering-Plough Canada 207093332 Manufacture
Revised: 02/2011 Schering-Plough HealthCare Products, Inc.