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Loratadine

Mylan Institutional Inc.

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Original Prescription Strength Non-Drowsy*

Indoor and Outdoor Allergies

*When taken as directed. See Drug Facts Panel.

TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.

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
or kidney disease

ask a doctor

  • TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.
  • •store between 20° to 25°C (68° to 77°F)
  • •protect from excessive moisture

Inactive Ingredients

Corn starch, lactose monohydrate and magnesium stearate.

1-800-848-0462

  • •Serious side effects associated with use of this product may be reported to this number.

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.

Distributed by:
Mylan Institutional Inc.
Rockford, IL 61103 U.S.A.

S-11333
10/12

PRINCIPAL DISPLAY PANEL – 10 mg

NDC 51079-246-20

LORATADINE
TABLETS, USP
10 mg

Antihistamine

100 Tablets (10 x 10)

Original Prescription Strength    Non-Drowsy*

*When taken as directed. See enclosed leaflet.

Indoor and Outdoor Allergies

24 Hour Relief (See Uses section of enclosed leaflet)

TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE
TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.

Loratadine

loratadine TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:51079-246
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
LORATADINE loratadine 10 mg

Inactive Ingredients

Ingredient Name Strength
STARCH, CORN
lactose monohydrate
MAGNESIUM STEARATE

Product Characteristics

Color Size Imprint Code Shape
WHITE (white to off-white) 6 mm G;L;10 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:51079-246-01 1 in 1 BLISTER PACK
2 NDC:51079-246-20 100 in 1 BOX, UNIT-DOSE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076154 2013-04-30


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Be sure to consult your doctor before taking any medication!
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