LORATADINE  - loratadine solution 
Silarx Pharmaceuticals, Inc


Children's Loratadine Oral Solution

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

Purpose: Antihistamine


temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:


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.


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.



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

Carton Label

Container Label

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  
propylene glycol  
sodium benzoate  
Product Characteristics
Color      Score     
Shape Size
Flavor GRAPE (grape flavor) Imprint Code
# 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