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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 IF
    8. IF PREGNANT OR BREAST-FEEDING
    9. KEEP OUT OF REACH OF CHILDREN.
    10. DIRECTIONS
    11. OTHER INFORMATION
    12. INACTIVE INGREDIENTS
    13. PRINCIPAL DISPLAY PANEL

Loratadine Product Label

The following document was submitted to the FDA by the labeler of this product Publix Super Markets 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.

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



  • store between 20 and 25° C (68 and 77° F)
  • protect from excessive moisture
  • TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.

Inactive Ingredients



Corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch


Principal Display Panel



Publix

24 - HOUR

allergy relief

LORATADINE TABLETS USP, 10 mg

ANTIHISTAMINE

  • sneezing
  • runny nose
  • itchy, watery eyes
  • itchy throat or nose

    • 10 TABLETS

    NON-DROWSY*

    *When taken as directed.

    See Drug Facts Panel.

    **Compare to Active Ingredient in Claritin®

    DISTRIBUTED BY PUBLIX SUPER MARKETS, INC.

    5084017/0211


* Please review the disclaimer below.