Label: LORATADINE - loratadine solution
- NDC Code(s): 0904-6234-20
- Packager: Major Pharmaceuticals, Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Updated June 27, 2014
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- Loratadine Oral Solution - Allergy
- ACTIVE INGREDIENT
Active Ingredient: Loratadine 5 mg (in each 5 mL(teaspoonful)(TSP))Close
temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- runny nose
- itchy, watery eyes
- itching of the nose or throat
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.
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
- Each teaspoonful contains: sodium 1 mg
- Safety Sealed. Do not use if imprinted seal around cap is broken or missing
- Store between 20° to 25°C (68° to 77°F)
- Inactive ingredients
Butylated hydroxylanisole, citric acid, glycerin, grape flavor, propylene glycol, purified water, sodium benzoate, sucralose.Close
31778 Enterprise Drive,
Livonia, MI 48150 USA
- INGREDIENTS AND APPEARANCE
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 Contains Packaging # 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)