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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. WARNINGS
    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. QUESTIONS OR COMMENTS?
    14. PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 MG CONTAINER CARTON (30 TABLETS)

Loratadine Product Label

The following document was submitted to the FDA by the labeler of this product Kroger Company. 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

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 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 (1-800-222-1222) 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




  • Tamper-evident: do not use if foil seal under cap, printed with “SEALED for YOUR PROTECTION” is missing, open or broken
  • store at 20° to 25°C (68° to 77°F)
  • protect from excessive moisture

Inactive Ingredients



lactose monohydrate, magnesium stearate, pregelatinized starch (maize), sodium starch glycolate.


Questions Or Comments?




1-800-632-6900
 DISTRIBUTED BY THE KROGER CO.
CINCINNATI, OHIO 45202
MADE IN INDIA

Code: TS/DRUGS/22/2009


Package Label-Principal Display Panel - 10 Mg Container Carton (30 Tablets)



COMPARE TO the active ingredient of CLARITIN® TABLETS **See bottom panel
NDC 30142-066-09
Kroger®
Non-Drowsy*
Allergy Relief
Loratadine Tablets USP 10 mg/Antihistamine

INDOOR & OUTDOOR ALLERGIES
RELIEF OF: Sneezing; Runny Nose;
Itchy, Watery Eyes; Itchy Throat or Nose

*When taken as directed. See Drug Facts Panel.

24
HOUR

actual
size            L

30 TABLETS



PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (45 Tablets Bottle) - loratadine fig1

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (45 Tablets Bottle) - loratadine fig1


* Please review the disclaimer below.