Loratadine by Mylan Pharmaceuticals Inc. LORATADINE tablet

Loratadine by

Drug Labeling and Warnings

Loratadine by is a Otc medication manufactured, distributed, or labeled by Mylan Pharmaceuticals Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

PRINCIPAL DISPLAY PANEL

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

INGREDIENTS AND APPEARANCE

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)