LORATADINE- loratadine tablet 
Mylan Pharmaceuticals Inc.

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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 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

PRODUCT PACKAGING

NDC 0378-8880-10

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.

RMX8880C1

100 Tablets

Loratadine Tablets 10 mg Bottles Front First Layer
Loratadine Tablets 10 mg Bottles Back of Front Layer
Loratadine Tablets 10 mg Bottles Base Layer
LORATADINE 
loratadine tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0378-8880
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE 10 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN (UNII: O8232NY3SJ)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
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 Marketing Start Date Marketing End Date
1 NDC:0378-8880-10 1000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/01/2011
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076154 06/01/2011
Labeler - Mylan Pharmaceuticals Inc. (059295980)

Revised: 11/2013
Document Id: 1392dd15-842c-4689-87ba-caafc0503bca
Set id: 3b307aea-5a68-4c82-959a-cda4ffbd0a4a
Version: 6
Effective Time: 20131115
 
Mylan Pharmaceuticals Inc.