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  5. Label Information: Loratadine

FDA Label for Loratadine

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (IN EACH TABLET)
    2. PURPOSE
    3. USES
    4. DO NOT USE
    5. ASK A DOCTOR BEFORE USE IF YOU HAVE
    6. WHEN USING THIS PRODUCT
    7. STOP USE AND ASK A DOCTOR
    8. IF PREGNANT OR BREAST-FEEDING,
    9. KEEP OUT OF REACH OF CHILDREN.
    10. DIRECTIONS
    11. OTHER INFORMATION
    12. STORAGE AND HANDLING
    13. INACTIVE INGREDIENTS
    14. QUESTIONS OR COMMENTS?
    15. OTHER
    16. HOW SUPPLIED

Loratadine Product Label

The following document was submitted to the FDA by the labeler of this product A-s Medication Solutions. 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 (In Each Tablet)



Loratadine, USP 10 mg


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

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 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.


Directions



adults and children 6 years 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



  • •Safety sealed: do not use if the imprinted bottle seal is open or torn (for bottle only).
  • •Safety sealed: do not use if open or torn (for blister package only).

Storage And Handling



  • •Store at 20° to 25°C (68° to 77°F) (see USP Controlled Room Temperature).

Inactive Ingredients



Lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate.


Questions Or Comments?



1-800-206-7821


Other



© 2005 NorthStar Healthcare Holdings     I10-2015M

Manufactured for: Northstar Rx LLC

Memphis, TN 38141.

Manufactured by: Sandoz Inc.

Princeton, NJ 08540.


How Supplied



Product: 50090-3620

NDC: 50090-3620-0 10 TABLET in a BOTTLE


* Please review the disclaimer below.