Label: LORATADINE - loratadine solution 

  • Label RSS
  • 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.

Drug Label Information

Updated 06/14

If you are a consumer or patient please visit this version.

  • Loratadine Oral Solution - Allergy
  • ACTIVE INGREDIENT

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

    Close
  • PURPOSE

    Purpose: Antihistamine

    Close
  • Uses

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

    •  runny nose
    • itchy, watery eyes
    • sneezing
    • itching of the nose or throat
    Close
  • 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 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.

    Close
  • Directions

    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
    Close
  • 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)
    Close
  • Inactive ingredients

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

    Close
  • Questions

    1-800-616-2471

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

    Close
  • INGREDIENTS AND APPEARANCE
    LORATADINE 
    loratadine solution
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0904-6234
    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  
    glycerin  
    propylene glycol  
    sodium benzoate  
    sucralose  
    water  
    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)
    Close