Label: LORATADINE solution

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated May 14, 2024

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  • Loratadine Oral Solution - Allergy
  • ACTIVE INGREDIENT
    Active Ingredient: Loratadine 5 mg (in each 5 mL(teaspoonful)(TSP))
  • PURPOSE
    Purpose: Antihistamine
  • 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
  • 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 ...
  • 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 ...
  • 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.
  • Questions
    DISTRIBUTED BY: ATLANTIC BIOLOGICALS CORP. MIAMI, FL 33179
  • Loratadine Oral Solution - Hives Relief
  • ACTIVE INGREDIENT
    Active Ingredient: Loratadine 5 mg (in each 5 mL(teaspoonful(tsp)))
  • PURPOSE
    Purpose: Antihistamine
  • Uses
    relieves itching due to hives (urticaria). This product will not prevent hives or an allergic skin reaction from occurring.
  • Warnings
    Severe Allergy Warning: Get emergency help immediately if you have hives along with any of the following symptoms: trouble swallowing - dizziness or loss of consciousness - swelling of ...
  • Directions
    adults and children 6 years and over -  2 teaspoonfuls (tsp) daily; do not take more than 2 teaspoonfuls (tsp) in 24 hours -  children under 6 years of age -  ask a doctor -  consumers ...
  • Inactive ingredients
    Butylated hydroxyanisole, citric acid, glycerin, grape flavor, propylene glycol, purified water, sodium benzoate, sucralose.
  • Questions
    DISTRIBUTED BY: ATLANTIC BIOLOGICALS CORP. MIAMI, FL 33179
  • Patient Leaflet
    Once Daily / Non-Drowsy* Loratadine Oral Solution - Hives Relief - 5 mg per 5 mL - Antihistamine - What you should know about: Non- Drowsy* Loratadine Oral Solution – Hives Relief - Original Prescription ...
  • PRINCIPAL DISPLAY PANEL
    NDC 17856-0557-1
  • INGREDIENTS AND APPEARANCE
    Product Information