FEXOFENADINE HYDROCHLORIDE  - fexofenadine hydrochloride tablet, film coated 
St Marys Medical Park Pharmacy

----------

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:

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

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

Fexofenadine Hydrochloride Tablets, 180 mg Carton Image 1

Fexofenadine Hydrochloride Tablets, 180 mg Carton Image 2

fexofenadine180mglabel

FEXOFENADINE HYDROCHLORIDE  
fexofenadine hydrochloride tablet, film coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:60760-104(NDC:45802-571)
Route of Administration ORAL DEA Schedule     
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)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
POVIDONE (UNII: FZ989GH94E)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Product Characteristics
Color ORANGE (peach) Score no score
Shape ROUND Size 12mm
Flavor Imprint Code 93;7253
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:60760-104-30 30 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076447 01/10/2013
Labeler - St Marys Medical Park Pharmacy (063050751)
Establishment
Name Address ID/FEI Business Operations
St Marys Medical Park Pharmacy 063050751 relabel(60760-104) , repack(60760-104)
Establishment
Name Address ID/FEI Business Operations
Teva Pharmaceutical Industries Ltd. 533065798 manufacture(60760-104)

Revised: 1/2013
Document Id: dc5901bc-99a7-45b0-87b9-37368a423ae4
Set id: 27da5da7-3f3c-4c19-b3b8-5a4ba58fa711
Version: 1
Effective Time: 20130110
 
St Marys Medical Park Pharmacy