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Fexofenadine hydrochloride

Medically reviewed by Drugs.com. Last updated on Sep 3, 2020.

Dosage form: tablet
Ingredients: Fexofenadine Hydrochloride 30mg
Labeler: Dr. Reddy's Laboratories Limited
NDC Code: 55111-782

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
  • store between 20° and 25°C (68° and 77°F)
  • protect from excessive moisture
  • this product meets the requirements of USP Dissolution Test 4

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

PACKAGE LABEL PRINCIPAL DISPLAY PANEL SECTION

Bottle label:

Fexofenadine HCL Tablets, 30 mg Carton:

Fexofenadine HCL Tablets USP, 60 mg Carton:

Fexofenadine HCL Tablets USP, 180 mg Carton Label:

FEXOFENADINE HYDROCHLORIDE 
fexofenadine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55111-782
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Fexofenadine Hydrochloride (FEXOFENADINE) Fexofenadine Hydrochloride30 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
ShapeOVALSize4mm
FlavorImprint Code192;R
Contains    
Packaging
#Item CodePackage Description
1NDC:55111-782-3030 TABLET in 1 BOTTLE
2NDC:55111-782-9090 TABLET in 1 BOTTLE
3NDC:55111-782-01100 TABLET in 1 BOTTLE
4NDC:55111-782-7810 BLISTER PACK in 1 CARTON
4NDC:55111-782-7910 TABLET in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07650201/03/2011
FEXOFENADINE HYDROCHLORIDE 
fexofenadine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55111-783
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Fexofenadine Hydrochloride (FEXOFENADINE) Fexofenadine Hydrochloride60 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
ShapeOVALSize5mm
FlavorImprint Code193;R
Contains    
Packaging
#Item CodePackage Description
1NDC:55111-783-3030 TABLET in 1 BOTTLE
2NDC:55111-783-6060 TABLET in 1 BOTTLE
3NDC:55111-783-9090 TABLET in 1 BOTTLE
4NDC:55111-783-01100 TABLET in 1 BOTTLE
5NDC:55111-783-7810 BLISTER PACK in 1 CARTON
5NDC:55111-783-7910 TABLET in 1 BLISTER PACK
6NDC:55111-783-282 BLISTER PACK in 1 CARTON
66 TABLET in 1 BLISTER PACK
7NDC:55111-783-244 BLISTER PACK in 1 CARTON
76 TABLET in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07650201/03/2011
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, 55111-782, 55111-783), manufacture(55111-784, 55111-782, 55111-783)
Establishment
NameAddressID/FEIOperations
Reed-Lane, Inc.001819879repack(55111-784, 55111-782, 55111-783)
Establishment
NameAddressID/FEIOperations
Quality Packaging Specialists International, LLC080629831repack(55111-784)
Establishment
NameAddressID/FEIOperations
Dr. Reddy's Laboratories Louisiana, LLC830397282repack(55111-784)
Establishment
NameAddressID/FEIOperations
DR. REDDY'S LABORATORIES LIMITED 860037244repack(55111-784)

 
Dr. Reddy's Laboratories Limited

Further information

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