FEXOFENADINE HYDROCHLORIDE- fexofenadine hydrochloride tablet 
Dr. Reddy's Laboratories Limited

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Active ingredient(s)

Fexofenadine HCl USP, 180 mg

Purpose

Antihistamine

Use(s)

temporarily relieves these symptoms due to hay fever or otherupper respiratory allergies:

  • runny nose
  • itchy, watery eys
  • sneezing
  • itching of the nose or Throad



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 doctorshould 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 doctor if

Allergy

an allergic reaction to this product occurs. Seek medical help right away.

Pregnancy/Breastfeeding

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 agedo not use
Adults 65 years of age  and olderask a doctor
consumers with kidney diseaseask a doctor

Other information

safety sealed: do not use if carton is opened or if individual blister units are torn or opened.

Storage

store between 20° - 25°C (68° - 77°F)

protect from excessive moisture

Inactive ingredients

colloidal silicon dioxide, corn starch, croscarmellose sodium, magnesium stearate, mannitol, and powdered cellulose, opadry pink 03B54504 containing FD&C Red no. 40, hypromellose, iron oxide black, polyethylene glycol and titanium dioxide.

Questions

call toll-free 1-888-375-3784

Manufactured by:

Dr. Reddy’s Laboratories Louisiana LLC,

8800 Line Ave Shreveport, LA, 71106. 

OR

Manufactured by:

Dr. Reddy’s Laboratories Limited

Bachepalli - 502 325 INDIA

Principal Display Panel

Container carton label : 180 mg - 30's count

container3

Principal Display Panel

Blister Carton abel : 180 mg - Allergy

carton5

FEXOFENADINE HYDROCHLORIDE 
fexofenadine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55111-784
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 
magnesium stearate 
mannitol 
POWDERED CELLULOSE 
FD&C RED NO. 40 
HYPROMELLOSE 2910 (6 MPA.S) 
FERRIC OXIDE BLACK 
polyethylene glycol 400 
TITANIUM DIOXIDE 
STARCH, CORN 
Product Characteristics
ColorPINKScoreno score
ShapeOVALSize7mm
FlavorImprint Code 194;R
Contains    
Packaging
#Item CodePackage Description
1NDC:55111-784-3030 in 1 BOTTLE
2NDC:55111-784-4545 in 1 BOTTLE
3NDC:55111-784-432 in 1 CARTON
3NDC:55111-784-3030 in 1 BOTTLE
4NDC:55111-784-9090 in 1 BOTTLE
5NDC:55111-784-071 in 1 CARTON
55 in 1 BLISTER PACK
6NDC:55111-784-293 in 1 CARTON
65 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07650204/15/2011
Labeler - Dr. Reddy's Laboratories Limited (862179079)
Establishment
NameAddressID/FEIBusiness Operations
Dr. Reddy's Laboratories Limited (FTO III)918608162manufacture, analysis

Revised: 04/2011
Document Id: 4954e7ba-2027-03ae-afc4-25a463431cbf
Set id: 864e3052-5787-bf11-9d17-11274ca2304f
Version: 4
Effective Time: 20110425
 
Dr. Reddy's Laboratories Limited