FEXOFENADINE HYDROCHLORIDE tablet, film coated

Fexofenadine hydrochloride by

Drug Labeling and Warnings

Fexofenadine hydrochloride by is a Otc medication manufactured, distributed, or labeled by Wal-Mart Stores, Inc, Aurolife Pharma, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT(S)

Fexofenadine HCl USP, 180 mg

PURPOSE

Antihistamine

USE(S)

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 aluminium or magnesium antacids
• do not take with fruit juices (see Directions)

STOP USE AND ASK 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

• safety sealed: do not use if carton is opened or if individual blister units are torn or opened
• store between 200 and 250C (680 and 770F)
• protect from excessive moisture and light

INACTIVE INGREDIENTS

anhydrous lactose, colloidal silicon dioxide, corn starch,croscarmellose sodium, hypromellose, lactose monohydrate, polyethylene glycol 400, pregelatinized corn starch, red iron oxide, stearic acid, titanium dioxide, and yellow iron oxide

QUESTIONS OR COMMENTS?

call 1-888-287-1915

PRINCIPAL DISPLAY PANEL

NDC: 49035-995-62

Non-Drowsy
Original Prescription Strength

Fexofenadine HCl Tablets USP,
180 mg/Antihistamine

Allergy Relief

Indoor and Outdoor Allergies
Relief of:

• Sneezing
• Runny nose
• Itchy, watery eyes
• Itchy nose or throat                                                                    180 mg EACH  15 TABLETS

INGREDIENTS AND APPEARANCE

FEXOFENADINE HYDROCHLORIDE 
fexofenadine hydrochloride tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49035-995
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
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STARCH, CORN (UNII: O8232NY3SJ)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
HYPROMELLOSES (UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
FERRIC OXIDE RED (UNII: 1K09F3G675)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)

Product Characteristics
Color	ORANGE (Peach)	Score	no score
Shape	CAPSULE (Bevel Edge, Biconvex)	Size	17mm
Flavor		Imprint Code	E;44
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49035-995-62	3 in 1 CARTON	09/30/2015
1	NDC: 49035-995-60	5 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA202039	09/30/2015

Labeler - Wal-Mart Stores, Inc (051957769)

Establishment
Name	Address	ID/FEI	Business Operations
Aurolife Pharma, LLC		829084461	MANUFACTURE(49035-995)