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  5. Label Information: Loratadine

FDA Label for Loratadine

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT(S)
    2. PURPOSE
    3. USE(S)
    4. WARNINGS
    5. ASK A DOCTOR BEFORE USE IF
    6. WHEN USING THIS PRODUCT
    7. STOP USE AND ASK DOCTOR IF
    8. PREGNANCY/BREASTFEEDING
    9. KEEP OUT OF REACH OF CHILDREN
    10. DIRECTIONS
    11. INACTIVE INGREDIENTS
    12. STORAGE
    13. PRINCIPAL DISPLAY PANEL

Loratadine Product Label

The following document was submitted to the FDA by the labeler of this product Marksans Pharma Limited. 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.

Active Ingredient(S)




Loratadine  10mg




Purpose



Antihistamine


Use(S)



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

• runny nose

• sneezing

• itchy, water eyes

• itching of the nose or throat




Warnings



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



an allergic reaction to this product occurs. Seek medical help right away


Pregnancy/Breastfeeding



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.


Directions



Adults and children  6 years and over: 1 capsule daily; Not more than 1 capsule in 24 hours.
Children under 6 years of age: ask a doctor.
Consumers with Liver or kidney disease: ask a doctor.


Inactive Ingredients



FD&C Blue no. 1, gelatine, mono anddiglyceride of caprilic/capric acid, pharmaceutical ink, polysorbate 80,povidone, purified water, sorbitol, sorbitan solution.


Storage



Store at 20°-25°C (68°-77°F).

Protect from freezing.

Safely sealed: do not use if the safety seal is open or torn.


Principal Display Panel



NDC# 25000-021-13
Loratadine Capsules, 10 mg
600 counts Bottle Label







NDC# 25000-021-34
Loratadine Capsules, 10 mg
28 counts Blister Pack





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