Fexofenadine HCl by Valu Merchandisers Company (Best Choice) / P and L Development of New York Corporation FEXOFENADINE HCL tablet

Fexofenadine HCl by

Drug Labeling and Warnings

Fexofenadine HCl by is a Otc medication manufactured, distributed, or labeled by Valu Merchandisers Company (Best Choice), P and L Development of New York Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

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

• store at 20°-25°C (68°-77°F)
• protect from excessive moisture

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide red, iron oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone k-30, talc, titanium dioxide.

Questions or comments?

call toll free 1-877-753-3935 Monday- Friday 9AM- 5PM EST

Package/Label Principal Display Panel

Compare to the active ingredient in Allegra® Allergy 24 hour*

ORIGINAL PRESCRIPTION STRENGTH

NON-DROWSY

Fexofenadine HCl tablets, USP 180 mg

Antihistamine

ALLERGY

Indoor and outdoor allergies

24 Hour Relief of:

• sneezing
• runny nose
• itchy, watery eyes
• itchy nose or throat

*This product is not manufactured or distributed by Chattem Inc., distributor of Allegra® Allergy 24 hour

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

SAFETY SEALED: DO NOT USE IF CARTON IS OPEN OR IF INNER SEAL IMPRINTED WITH "SEALED FOR YOUR PROTECTION" IS MISSING OR TORN

Product Label

Fexofenadine HCl 180 mg

INGREDIENTS AND APPEARANCE

FEXOFENADINE HCL 
fexofenadine hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63941-189(NDC:55648-987)
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
HYPROMELLOSES (UNII: 3NXW29V3WO)
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)
POVIDONES (UNII: FZ989GH94E)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	WHITE	Score	no score
Shape	CAPSULE	Size	17mm
Flavor		Imprint Code	W987
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63941-189-30	1 in 1 BOX
1		30 in 1 BOTTLE
2	NDC: 63941-189-60	1 in 1 BOX
2		60 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA079112	06/04/2012

Labeler - Valu Merchandisers Company (Best Choice) (868703513)

Registrant - P and L Development of New York Corporation (800014821)