LORATADINE  - loratadine solution 
Silarx Pharmaceuticals, Inc

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Children's Loratadine Oral Solution

Active Ingredient: Loratadine 5 mg (in each 5 mL)

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 allergic reaction to this product or any of it's 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 way.

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

adults and children 6 years and over
2 teaspoonfuls daily; do not take more than 2 teaspoonfuls in 24 hours
children 2 to under 6 years of age
1 teaspoonful daily; do not take more than 1 teaspoonful 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

Butylated hydroxylanisole, citric acid, glycerin, grape flavor, propylene glycol, purified water, sodium benzoate, sucralose.

Questions

1-888-974-5279

Manufactured by:
Silarx Pharmaceuticals, Inc.
19 West Street
Spring Valley, NY 10977 USA
Revised – August 2010


Carton Label

Container Label


LORATADINE 
loratadine   solution
Product Information
Product Type HUMAN OTC DRUG NDC Product Code (Source) 54838-558
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
anhydrous citric acid  
butylated hydroxyanisole  
glycerin  
propylene glycol  
sodium benzoate  
sucralose  
water  
Product Characteristics
Color      Score     
Shape Size
Flavor GRAPE (grape flavor) Imprint Code
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 54838-558-40 120 mL In 1 CARTON None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077421 11/24/2010

Labeler - Silarx Pharmaceuticals, Inc (161630033)
Revised: 11/2010 Silarx Pharmaceuticals, Inc