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

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 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)
    Close