LORATADINE - loratadine solution 
Major Pharmaceuticals, Inc


Children's Loratadine Oral Solution

Loratadine Oral Solution - Allergy

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

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 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.


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

Inactive ingredients

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



Distributed by:
Major Pharmaceuticals
31778 Enterprise Drive,
Livonia, MI 48150 USA

Carton Label

loratadine solution
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0904-6234
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Loratadine (UNII: 7AJO3BO7QN) (Loratadine - UNII:7AJO3BO7QN) Loratadine 5 mg  in 5 mL
Inactive Ingredients
Ingredient Name Strength
anhydrous citric acid (UNII: XF417D3PSL)  
butylated hydroxyanisole (UNII: REK4960K2U)  
glycerin (UNII: PDC6A3C0OX)  
propylene glycol (UNII: 6DC9Q167V3)  
sodium benzoate (UNII: OJ245FE5EU)  
sucralose (UNII: 96K6UQ3ZD4)  
water (UNII: 059QF0KO0R)  
Product Characteristics
Color      Score     
Shape Size
Flavor GRAPE (grape flavor) Imprint Code
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0904-6234-20 120 mL in 1 CARTON
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077421 02/17/2011
Labeler - Major Pharmaceuticals, Inc (191427277)

Revised: 6/2014
Document Id: cbc33bcc-7963-47c9-a772-d303fe771c41
Set id: 72500b55-efa6-4b7c-9946-cee6bfc05970
Version: 7
Effective Time: 20140627
Major Pharmaceuticals, Inc