FEXOFENADINE HYDROCHLORIDE- fexofenadine hydrochloride tablet, film coated 
UDL Laboratories Inc.

----------

Drug Facts

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

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

60 mg (12 Hour Relief)
adults and children 12 years
of age and over
take one 60 mg tablet with water
every 12 hours; do not take
more than 2 tablets in 24 hours
children under 12 years of agedo not use
adults 65 years of age and olderask a doctor
consumers with kidney diseaseask a doctor
180 mg (24 Hour Relief)
adults and children 12 years
of age and over
take one 180 mg tablet with
water once a day; do not take
more than 1 tablet in 24 hours
children under 12 years of agedo not use
adults 65 years of age and olderask a doctor
consumers with kidney diseaseask a doctor

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:
UDL Laboratories, Inc.
Rockford, IL 61103

S-11117
7/15/11

  

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

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.

Fexofenadine Hydrochloride Tablets 60 mg Bottles
Unit Carton

  

PRINCIPAL DISPLAY PANEL - 180 mg

NDC 51079-548-20

FEXOFENADINE
HYDROCHLORIDE
TABLETS, USP 180 mg

Antihistamine
100 Tablets (10 x 10)

Original Prescription Strength Non-Drowsy

Indoor & 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

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

S-11115

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.

Fexofenadine Hydrochloride Tablets 180 mg Bottles
Unit Carton
FEXOFENADINE HYDROCHLORIDE 
fexofenadine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:51079-547
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE) FEXOFENADINE HYDROCHLORIDE60 mg
Inactive Ingredients
Ingredient NameStrength
BUTYLATED HYDROXYANISOLE 
CROSPOVIDONE 
FD&C BLUE NO. 1 
HYPROMELLOSES 
LACTOSE MONOHYDRATE 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYDEXTROSE 
POLYETHYLENE GLYCOLS 
POLYSORBATE 80 
POVIDONE 
SODIUM LAURYL SULFATE 
TITANIUM DIOXIDE 
TRIACETIN 
Product Characteristics
ColorBLUEScoreno score
ShapeROUNDSize8mm
FlavorImprint Code M;753
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51079-547-20100 in 1 BOX, UNIT-DOSE
1NDC:51079-547-011 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07708110/07/2011
FEXOFENADINE HYDROCHLORIDE 
fexofenadine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:51079-548
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE) FEXOFENADINE HYDROCHLORIDE180 mg
Inactive Ingredients
Ingredient NameStrength
BUTYLATED HYDROXYANISOLE 
CROSPOVIDONE 
FD&C BLUE NO. 1 
HYPROMELLOSES 
LACTOSE MONOHYDRATE 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYDEXTROSE 
POLYETHYLENE GLYCOLS 
POLYSORBATE 80 
POVIDONE 
SODIUM LAURYL SULFATE 
TITANIUM DIOXIDE 
TRIACETIN 
Product Characteristics
ColorBLUEScoreno score
ShapeOVAL (capsule-shaped) Size18mm
FlavorImprint Code M;755
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51079-548-20100 in 1 BOX, UNIT-DOSE
1NDC:51079-548-011 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07708110/07/2011
Labeler - UDL Laboratories Inc. (039615992)

Revised: 7/2011
 
UDL Laboratories Inc.