Children's Loratadine Oral Solution

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 TypeHUMAN OTC DRUGNDC Product Code (Source)54838-558
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Loratadine (Loratadine) Loratadine5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
anhydrous citric acid 
butylated hydroxyanisole 
glycerin 
propylene glycol 
sodium benzoate 
sucralose 
water 
Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPE (grape flavor) Imprint Code
Contains    
Packaging
#NDCPackage DescriptionMultilevel Packaging
154838-558-40120 mL In 1 CARTONNone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07742111/24/2010

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