HEALTHY ACCENTS ALLERGY RELIEF- fexofenadine hydrochloride tablet, film coated
DZA Brands LLC

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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 printed foil under cap is broken or missing
•: 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?

1-866-322-2439

Package/Label Principal Display Panel

Compare to Allegra® Allergy tablets active ingredient

24 hour

original prescription strength

allergy relief

fexofenadine hydrochloride tablets, 180 mg/ antihistamine

indoor & outdoor allergies

relief of:

sneezing

runny nose

itchy, watery eyes

itchy nose or throat

non-drowsy

actual size

180 mg each

HEALTHY ACCENTS ALLERGY RELIEF
fexofenadine hcl tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55316-998
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
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
HYPROMELLOSES
FERROSOFERRIC OXIDE
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOLS
TITANIUM DIOXIDE
POVIDONES

Product Characteristics
Color	ORANGE (peach)	Score	no score
Shape	ROUND	Size	12mm
Flavor		Imprint Code	93;7253
Contains

Packaging
#	Item Code	Package Description
1	NDC:55316-998-95	1 in 1 CARTON
1		45 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA076447	06/15/2007

Labeler - DZA Brands LLC (090322194)

Revised: 10/2012

Document Id: 07f5e778-6525-443f-a120-8d4fb53c1b09

Set id: 07f5e778-6525-443f-a120-8d4fb53c1b09

Version: 1

Effective Time: 20121024

DZA Brands LLC