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  5. Label Information: Loratadine

FDA Label for Loratadine

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. USES
    4. WARNINGS
    5. OTC - ASK DOCTOR
    6. OTC - WHEN USING
    7. OTC - STOP USE
    8. OTC - PREGNANCY OR BREAST FEEDING
    9. OTC - KEEP OUT OF REACH OF CHILDREN
    10. DIRECTIONS
    11. OTHER INFORMATION
    12. INACTIVE INGREDIENTS
    13. QUESTIONS

Loratadine Product Label

The following document was submitted to the FDA by the labeler of this product Atlantic Biologicals Corps. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Active Ingredient



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


Otc - 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



ever had allergic reaction to this product or any of it's ingredients Do not use if you have


Otc - Ask Doctor



liver or kidney disease. Your doctor should determine if you need a different dose. Ask a doctor before use if you have


Otc - When Using



do not take more than directed. Taking more than directed may cause drowsiness. When using this product


Otc - Stop Use



an allergic reaction to this product occurs. Seek medical help right away. Stop use and ask a doctor if


Otc - Pregnancy Or Breast Feeding



, ask a health professional before use. If pregnant or breast-feeding


Otc - Keep Out Of Reach Of Children



. In case of overdose, get medical help or contact a Poison Control Center right away. Keep out of reach of children


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

Other Information



  • : sodium 1 mg Each teaspoonful contains
  • 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



1-800-616-2471

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




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