FEXOFENADINE - fexofenadine hydrochloride tablet, film coated
Wockhardt USA LLC.

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Active ingredient (in each tablet)

For 30 mg:

Fexofenadine HCl 30 mg

For 60 mg:

Fexofenadine HCl 60 mg

For 180 mg:

Fexofenadine HCl 180 mg

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 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

For 30 mg:

adults and children 12 years of age and over	take two 30 mg tablets with water every 12 hours; do not take more than 4 tablets in 24 hours
children 6 to under 12 years of age	take one 30 mg tablet with water every 12 hours; do not take more than 2 tablets in 24 hours
children under 6 years of age	do not use
adults 65 years of age and older	ask a doctor
consumers with kidney disease	ask a doctor

For 60 mg:

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 age	do not use
adults 65 years of age and older	ask a doctor
consumers with kidney disease	ask a doctor

For 180 mg:

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 age	do not use
adults 65 years of age and older	ask a doctor
consumers with kidney disease	ask a doctor

Other information

safety sealed: do not use if carton is open or if inner seal imprinted with "Sealed for Your Protection" is missing or torn
safety sealed: do not use if carton is open or if individual blister unit is torn or open
store between 20° to 25°C (68° to 77°F)
protect from excessive moisture

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone K-30, talc, titanium dioxide

Questions or comments?

Call toll-free 1-800-346-6854

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FEXOFENADINE
fexofenadine tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:64679-744
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE)	FEXOFENADINE HYDROCHLORIDE	30 mg

Inactive Ingredients
Ingredient Name	Strength
CELLULOSE, MICROCRYSTALLINE
CROSCARMELLOSE SODIUM
HYPROMELLOSES
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL
POVIDONE K30
SILICON DIOXIDE
TALC
TITANIUM DIOXIDE

Product Characteristics
Color	WHITE	Score	no score
Shape	ROUND (round)	Size	7mm
Flavor		Imprint Code	W;30
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:64679-744-09	1 BLISTER PACK (1 BLISTER PACK) in 1 CARTON	contains a BLISTER PACK (64679-744-08)
1	NDC:64679-744-08	6 TABLET, FILM COATED (6 TABLET) in 1 BLISTER PACK	This package is contained within the CARTON (64679-744-09)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA079112	02/08/2012

FEXOFENADINE
fexofenadine tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:64679-982
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE)	FEXOFENADINE HYDROCHLORIDE	60 mg

Inactive Ingredients
Ingredient Name	Strength
CELLULOSE, MICROCRYSTALLINE
CROSCARMELLOSE SODIUM
HYPROMELLOSES
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL
POVIDONE K30
SILICON DIOXIDE
TALC
TITANIUM DIOXIDE

Product Characteristics
Color	WHITE	Score	no score
Shape	CAPSULE (Capsule)	Size	11mm
Flavor		Imprint Code	W;982
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:64679-982-09	2 BLISTER PACK (2 BLISTER PACK) in 1 CARTON	contains a BLISTER PACK (64679-982-08)
1	NDC:64679-982-08	6 TABLET, FILM COATED (6 TABLET) in 1 BLISTER PACK	This package is contained within the CARTON (64679-982-09)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA079112	02/08/2012

FEXOFENADINE
fexofenadine tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:64679-987
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE)	FEXOFENADINE HYDROCHLORIDE	180 mg

Inactive Ingredients
Ingredient Name	Strength
CELLULOSE, MICROCRYSTALLINE
CROSCARMELLOSE SODIUM
HYPROMELLOSES
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL
POVIDONE K30
SILICON DIOXIDE
TALC
TITANIUM DIOXIDE

Product Characteristics
Color	WHITE	Score	no score
Shape	CAPSULE (Capsule)	Size	17mm
Flavor		Imprint Code	W;987
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:64679-987-14	2 BOTTLE (2 BOTTLE) in 1 CARTON	contains a BOTTLE
1		45 TABLET, FILM COATED (45 TABLET) in 1 BOTTLE	This package is contained within the CARTON (64679-987-14)
2	NDC:64679-987-13	1 BOTTLE (1 BOTTLE) in 1 CARTON	contains a BOTTLE
2		45 TABLET, FILM COATED (45 TABLET) in 1 BOTTLE	This package is contained within the CARTON (64679-987-13)
3	NDC:64679-987-12	1 BOTTLE (1 BOTTLE) in 1 CARTON	contains a BOTTLE
3		30 TABLET, FILM COATED (30 TABLET) in 1 BOTTLE	This package is contained within the CARTON (64679-987-12)
4	NDC:64679-987-10	1 BLISTER PACK (1 BLISTER PACK) in 1 CARTON	contains a BLISTER PACK (64679-987-09)
4	NDC:64679-987-09	5 TABLET, FILM COATED (5 TABLET) in 1 BLISTER PACK	This package is contained within the CARTON (64679-987-10)
5	NDC:64679-987-11	3 BLISTER PACK (3 BLISTER PACK) in 1 CARTON	contains a BLISTER PACK (64679-987-09)
5	NDC:64679-987-09	5 TABLET, FILM COATED (5 TABLET) in 1 BLISTER PACK	This package is contained within the CARTON (64679-987-11)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA079112	02/08/2012

Labeler - Wockhardt USA LLC. (170508365)

Registrant - Wockhardt USA LLC. (170508365)

Establishment
Name	Address	ID/FEI	Operations
Wockhardt Limited		676257570	Manufacture

Revised: 02/2012 Wockhardt USA LLC.