Learn how to prepare for Severe Allergy Attacks.

Loratadine Tablet

Pronunciation

Dosage Form: tablet

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:

Slideshow: 2014 Update - First Time Brand-to-Generic Switches

  • 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 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

Manufactured in India by:
Matrix Laboratories Limited
Secunderabad–500 003, India
Code No.: MH/DRUGS/25/NKD/89

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

PRODUCT PACKAGING

NDC 0378-8880-93

Non-Drowsy*

Original Prescription
Strength

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.

30 TABLETS

RMX8880H

LORATADINE 
Loratadine Tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0378-8880
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LORATADINE (LORATADINE) LORATADINE 10 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN  
LACTOSE MONOHYDRATE  
MAGNESIUM STEARATE  
Product Characteristics
Color WHITE (white to off-white) Score no score
Shape ROUND Size 6mm
Flavor Imprint Code G;L;10
Contains         
Packaging
# Item Code Package Description
1 NDC:0378-8880-93 30 TABLET (TABLET) in 1 BOTTLE, PLASTIC
2 NDC:0378-8880-10 1000 TABLET (TABLET) in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076154 07/07/2010
Labeler - Mylan Pharmaceuticals Inc. (059295980)
Registrant - Mylan Pharmaceuticals Inc. (059295980)
Revised: 06/2010
 
Mylan Pharmaceuticals Inc.



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