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  5. Label Information: Loratadine

FDA Label for Loratadine

View Indications, Usage & Precautions

Table of Contents

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

Loratadine Product Label

The following document was submitted to the FDA by the labeler of this product Rising Pharmaceuticals, Inc. 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.

Drug Facts




Otc - Active Ingredient



Active Ingredient (in each tablet)

Loratadine, 10 mg USP


Otc - Purpose



Purpose

Antihistamine


Uses



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

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

Warnings



Do not use if you ever have had an allergic reaction to this product or any of its ingredients.


Otc - Ask Doctor



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


Otc - When Using



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


Otc - Stop Use



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


Otc - Pregnancy Or Breast Feeding



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


Otc - Keep Out Of Reach Of Children



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


Directions



 adults and children 6 years of age and over 1 tablet daily; not more than 1 tablet in 24 hours
children under 6 years of age  ask a doctor 
consumers with liver or kidney disease ask a doctor 


Other Information



  • Tamper-evident: do not use if foil seal under cap, printed with "SEALED for YOUR PROTECTION" is missing, open or broken.
  • Store between 20° - 25°C (68°-77°F)

Inactive Ingredient



Inactive ingredients corn starch, lactose monohydrate, magnesium stearate, povidone


Otc - Questions



Questions or comments?

Call 1-800-874-7464 Monday to Friday 9 AM to 5 PM EST


Package Label.Principal Display Panel



30 Count Container Label

30-Count-Label - 30 Count Label

30-Count-Label - 30 Count Label

100 Count Container Label


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