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Fexofenadine hydrochloride by Dr. Reddy's Laboratories Limited

Dosage form: tablet
Ingredients: Fexofenadine Hydrochloride 180mg
Labeler: Dr. Reddy's Laboratories Limited
NDC Code: 55111-784

Fexofenadine HCl Tablets USP

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
  • 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 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 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 printed foil inner seal on bottle is torn or missing

Storage
  • store between 20° and 25°C (68° and 77°F)
  • protect from excessive moisture
  • this product meets the requirements of USP Dissolution Test 2

Inactive ingredients

colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C Red no. 40, hypromellose, iron oxide black, magnesium stearate, mannitol, polyethylene glycol, powder cellulose and titanium dioxide

Questions?

Call 1-888-375-3784

Carton label

Bottle label

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) 
FERROSOFERRIC OXIDE 
POLYETHYLENE GLYCOL 400 
TITANIUM DIOXIDE 
STARCH, CORN 
Product Characteristics
ColorPINKScoreno score
ShapeOVALSize7mm
FlavorImprint Code194;R
Contains    
Packaging
#Item CodePackage Description
1NDC:55111-784-301 BOTTLE in 1 CARTON
130 TABLET in 1 BOTTLE
2NDC:55111-784-432 BOTTLE in 1 CARTON
230 TABLET in 1 BOTTLE
3NDC:55111-784-401 BOTTLE in 1 CARTON
340 TABLET in 1 BOTTLE
4NDC:55111-784-451 BOTTLE in 1 CARTON
445 TABLET in 1 BOTTLE
5NDC:55111-784-592 BOTTLE in 1 CARTON
560 TABLET in 1 BOTTLE
6NDC:55111-784-751 BOTTLE in 1 CARTON
670 TABLET in 1 BOTTLE
7NDC:55111-784-901 BOTTLE in 1 CARTON
790 TABLET in 1 BOTTLE
8NDC:55111-784-011 BOTTLE in 1 CARTON
8100 TABLET in 1 BOTTLE
9NDC:55111-784-151 BOTTLE in 1 CARTON
9150 TABLET in 1 BOTTLE
10NDC:55111-784-181 BOTTLE in 1 CARTON
10180 TABLET in 1 BOTTLE
11NDC:55111-784-051 BOTTLE in 1 CARTON
11500 TABLET in 1 BOTTLE
12NDC:55111-784-231 BLISTER PACK in 1 CARTON
122 TABLET in 1 BLISTER PACK
13NDC:55111-784-071 BLISTER PACK in 1 CARTON
135 TABLET in 1 BLISTER PACK
14NDC:55111-784-293 BLISTER PACK in 1 CARTON
145 TABLET in 1 BLISTER PACK
15NDC:55111-784-7810 BLISTER PACK in 1 CARTON
15NDC:55111-784-7910 TABLET in 1 BLISTER PACK
16NDC:55111-784-283 BLISTER PACK in 1 CARTON
1615 TABLET in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07650201/03/2011
Labeler - Dr. Reddy's Laboratories Limited (650562841)
Establishment
NameAddressID/FEIOperations
Dr. Reddy's Laboratories Limited (FTO III)918608162analysis(55111-784), manufacture(55111-784)
Establishment
NameAddressID/FEIOperations
Reed-Lane, Inc.001819879repack(55111-784)

 
Dr. Reddy's Laboratories Limited

← See all Fexofenadine hydrochloride brands

Medically reviewed on Jun 26, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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