Your browser does not support JavaScript! FEXOFENADINE HYDROCHLORIDE TABLET, FILM COATED [WESTERN FAMILY FOODS INC]
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FEXOFENADINE HYDROCHLORIDE tablet, film coated
[Western Family Foods Inc]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL Abbreviated New Drug Application
Drug Label Sections

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

ORIGINAL PRESCRIPTION STRENGTH

ALLERGY

NON-DROWSY

Fexofenadine Hydrochloride TABLETS, 180 mg

ANTIHISTAMINE

24 HOUR

INDOOR & OUTDOOR ALLERGIES

RELIEF OF: SNEEZING; RUNNY NOSE

ITCHY, WATERY EYES; ITCHY NOSE or THROAT

Actual Size

30 TABLETS

180 mg EACH

ONE MONTH SUPPLY

COMPARE TO ALLEGRA® ALLERGY ACTIVE INGREDIENT

Fexofenadine Hydrochloride Tablets, 180 mg Carton Image 1

Fexofenadine Hydrochloride Tablets, 180 mg Carton Image 1

Fexofenadine Hydrochloride Tablets, 180 mg Carton Image 2

Fexofenadine Hydrochloride Tablets, 180 mg Carton Image 2

FEXOFENADINE HYDROCHLORIDE 
fexofenadine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:55312-571
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE) FEXOFENADINE HYDROCHLORIDE180 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
CROSCARMELLOSE SODIUM 
HYPROMELLOSES 
FERROSOFERRIC OXIDE 
FERRIC OXIDE YELLOW 
LACTOSE MONOHYDRATE 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOLS 
POVIDONES 
TITANIUM DIOXIDE 
FERRIC OXIDE RED 
Product Characteristics
ColorORANGE (peach) Scoreno score
ShapeROUNDSize12mm
FlavorImprint Code 93;7253
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55312-571-391 in 1 CARTON
130 in 1 BOTTLE
2NDC:55312-571-331 in 1 CARTON
260 in 1 BOTTLE
3NDC:55312-571-2215 in 1 CARTON
31 in 1 BLISTER PACK
4NDC:55312-571-011 in 1 CARTON
470 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07644704/14/2011
Labeler - Western Family Foods Inc (192166072)

Revised: 3/2014
 
Western Family Foods Inc

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