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
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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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 DEA Schedule 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)