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  5. Label Information: Loratadine

FDA Label for Loratadine

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    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. QUESTIONS OR COMMENTS?
    14. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Loratadine Product Label

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

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 of kidney disease

ask a doctor


Other Information



  • •Tamper Evident: do not use if foil seal under cap is missing, open or broken.
  • •store between 20° to 25°C (68° to 77°F)
  • •protect from excessive moisture

Inactive Ingredients



Corn starch, lactose monohydrate and magnesium stearate.


Questions Or Comments?



call 1-877-446-3679 (1-877-4-INFO-RX)

Manufactured for:
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Made in India
Code No.: MH/DRUGS/25/NKD/89


Package Label.Principal Display Panel



PRODUCT PACKAGING

NDC 0378-8880-93

Original Prescription Strength

Non-Drowsy*

Loratadine
Tablets USP, 10 mg

Antihistamine

Indoor and Outdoor Allergies

24 Hour Relief of:

  • •Sneezing
  • •Runny Nose
  • •Itchy, Watery Eyes
  • •Itchy Throat or Nose

    • *When taken as directed. See Drug Facts Panel.

    RMX8880H1

    30 Tablets


* Please review the disclaimer below.