ALLERGY RELIEF- fexofenadine hydrochloride tablet, film coated
HyVee Inc

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Hy-Vee, Inc. Allergy Relief Drug Facts

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?

1-800-719-9260

Package/Label Principal Display Panel

Compare to the Active Ingredient of Allegra® Allergy Tablets

Non-Drowsy

Allergy Relief

FEXOFENADINE HYDROCHLORIDE TABLETS, 180 mg/ANTIHISTAMINE

Indoor & Outdoor Allergies

Relief of:

Sneezing

Runny Nose

Itchy, Watery Eyes

Itchy Nose or Throat

ORIGINAL PRESCRIPTION STRENGTH

ACTUAL SIZE

24 HOUR

45 Tablets 180 mg EACH

ALLERGY RELIEF
fexofenadine hcl tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG LABEL	Item Code (Source)	NDC:42507-692
Route of Administration	ORAL	DEA Schedule

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

Ingredient Name	Strength
Inactive Ingredients
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
HYPROMELLOSES
FERROSOFERRIC OXIDE
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOLS
POVIDONES
TITANIUM DIOXIDE

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

#	Item Code	Package Description
Packaging
1	NDC:42507-692-95	1 in 1 CARTON
1		45 in 1 BOTTLE
2	NDC:42507-692-76	1 in 1 CARTON
2		120 in 1 BOTTLE
3	NDC:42507-692-39	1 in 1 CARTON
3		30 in 1 BOTTLE
4	NDC:42507-692-13	5 in 1 CARTON
4		1 in 1 BLISTER PACK
5	NDC:42507-692-22	15 in 1 CARTON
5		1 in 1 BLISTER PACK

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA076447	02/12/2014

Labeler - HyVee Inc (006925671)

Revised: 2/2014

Document Id: 879bbd56-2cad-4eb1-b3fa-69af277f7f58

Set id: 879bbd56-2cad-4eb1-b3fa-69af277f7f58

Version: 1

Effective Time: 20140212

HyVee Inc