FEXOFENADINE HYDROCHLORIDE tablet, film coated

Active ingredient (in each tablet)

Fexofenadine HCl 180 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

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. (1-800-222-1222)

Directions

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
- do not use if blister unit is broken or torn (Use for Blister Configurations Only)
- do not use if printed foil under cap is broken or missing (Use for Bottle Configurations Only)
- store at 20°-25°C (68°-77°F)
- protect from excessive moisture
- this product meets the requirements of USP Dissolution Test 3
Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, titanium dioxide
Questions or comments?

1-800-719-9260
Package/Label Principal Display Panel

NDC: 66336-0561-XX
NDC: 66336-0561-30

COMPARE TO active ingredient of ALLEGRA® ALLERGY TABLETS

Original Prescription Strength

FEXOFENADINE HYDROCHLORIDE TABLETS, 180 mg

Antihistamine
ALLERGY

Relief of:

Sneezing

Runny Nose

Itchy, Watery Eyes

Itchy Nose or Throat

Indoor and Outdoor Allergies

24 HOUR

Non-Drowsy

actual size

180 mg EACH

INGREDIENTS AND APPEARANCE

FEXOFENADINE HYDROCHLORIDE
fexofenadine hydrochloride tablet, film coated

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
FEXOFENADINE HYDROCHLORIDE (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V)	FEXOFENADINE HYDROCHLORIDE	180 mg

Ingredient Name	Strength
Inactive Ingredients
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
HYPROMELLOSES (UNII: 3NXW29V3WO)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 66336-561-30	30 in 1 BOTTLE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA076447	04/14/2011

Labeler - Dispensing Solutions, Inc. (066070785)

Registrant - PSS World Medical, Inc. (101822682)

Name	Address	ID/FEI	Business Operations
Establishment
Dispensing Solutions, Inc.		066070785	relabel, repack

fexofenadine hydrochloride by