Fexofenadine Hydrochloride

Mylan Institutional Inc.

Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredient (in each tablet)
• Purpose
• Fexofenadine Hydrochloride Uses
• Warnings
  • Do not use
  • Ask a doctor before use
  • When using this product
  • Stop and ask a doctor if
  • If pregnant or breast-feeding,
  • Keep out of reach of children.
• Directions
• Fexofenadine Hydrochloride Other information
• Inactive ingredients
• Questions?
• HOW SUPPLIED

FULL PRESCRIBING INFORMATION

Original Prescription Strength

Non-Drowsy

Indoor & Outdoor Allergies

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

Active ingredient (in each tablet)

Fexofenadine hydrochloride USP

Purpose

Antihistamine

Fexofenadine Hydrochloride Uses

temporarily relieves these symptoms due to hay fever or
other upper respiratory allergies:

• •runny nose
• •sneezing
• •itchy, watery eyes
• •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 kidney disease. Your doctor
should determine if you need a different dose.

When using this product

• •do not take more than directed
• •do not take at the same time as aluminum or magnesium antacids
• •do not take with fruit juices (see Directions)

Stop 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

Fexofenadine Hydrochloride Other information

• • 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

Butylated hydroxyanisole, crospovidone, FD&C Blue No. 1
Aluminum Lake, hypromellose, lactose monohydrate, magnesium
stearate, microcrystalline cellulose, polydextrose, polyethylene glycol,
polysorbate 80, povidone, sodium lauryl sulfate, titanium dioxide
and triacetin.

Questions?

1-800-848-0462

• •Serious side effects associated with use of this product may be

reported to this number.

HOW SUPPLIED

Fexofenadine Hydrochloride Tablets, USP are available containing 60 mg
or 180 mg of fexofenadine hydrochloride, USP.

The 60 mg tablets are blue film-coated, round, unscored tablets
debossed with M over 753 on one side of the tablet and blank on the
other side. They are available as follows:

NDC 51079-547-20 - Unit dose blister packages of 100
(10 cards of 10 tablets each).

The 180 mg tablets are blue film-coated, caplet-shaped, unscored tablets
debossed with M 755 on one side of the tablet and blank on the other
side. They are available as follows:

NDC 51079-548-20 - Unit dose blister packages of 100
(10 cards of 10 tablets each).

Store between 20° to 25°C (68° to 77°F). Protect from excessive moisture.

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

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

S-11117 R1
11/13

PRINCIPAL DISPLAY PANEL - 60 mg

NDC 51079-547-20

FEXOFENADINE
HYDROCHLORIDE
TABLETS, USP
60 mg

Antihistamine 100 Tablets (10 x 10)

Original Prescription Strength Non-Drowsy

Indoor & Outdoor Allergies

12 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

Manufactured by:
Mylan Pharmceuticals Inc.
Morgantown, WV 26505 U.S.A.

S-11114 R1

Packaged and Distributed by:
UDL LABORATORIES, INC.
ROCKFORD, IL 61103

This unit dose package is not child resistant.
For institutional use only.
Keep this and all drugs out of the reach of children.
This container provides light-resistance.
See window for lot number and expiration date.