CHILDREN'S CLARITIN –loratadine

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 TypeHUMAN OTC DRUGNDC Product Code (Source)11523-7197
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Loratadine (Loratadine) Loratadine5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
propylene glycol 
glycerin 
edetate disodium 
sodium benzoate 
phosphoric acid 
sodium phosphate, monobasic 
sorbitol 
sucralose 
maltitol 
water 
Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#NDCPackage DescriptionMultilevel Packaging
111523-7197-11 BOTTLE In 1 CARTONcontains a BOTTLE
1120 mL In 1 BOTTLEThis package is contained within the CARTON (11523-7197-1)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02064103/01/2011

Labeler - Schering-Plough HealthCare Products, Inc. (039137567)
Establishment
NameAddressID/FEIOperations
Schering-Plough Canada207093332Manufacture
Revised: 02/2011Schering-Plough HealthCare Products, Inc.