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:

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 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 5 mg
do not use if tape imprinted with "SEALED FOR YOUR PROTECTION" on top and bottom flaps of carton is not intact.
store between 20° and 25°C (68° and 77°F)

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:

Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat or Nose

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: 02/2011Schering-Plough HealthCare Products, Inc.