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

----------

Fexofenadine HCl Tablets USP

Active ingredient(s)

Fexofenadine HCl USP, 30 mg

Fexofenadine HCl USP, 60 mg

Fexofenadine HCl USP, 180 mg

Purpose

Antihistamine

Use(s)

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 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

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:

container180mg

Fexofenadine HCl Tablets, 30 mg Carton:

carton30mg

Fexofenadine HCl Tablets USP, 60 mg Carton:

carton60mg

Fexofenadine HCl Tablets USP, 180 mg Carton Label:

carton

FEXOFENADINE HYDROCHLORIDE 
fexofenadine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55111-782
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Fexofenadine Hydrochloride (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V) Fexofenadine Hydrochloride30 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
magnesium stearate (UNII: 70097M6I30)  
mannitol (UNII: 3OWL53L36A)  
POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
polyethylene glycol 400 (UNII: B697894SGQ)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
ColorPINKScoreno score
ShapeOVALSize4mm
FlavorImprint Code 192;R
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55111-782-3030 in 1 BOTTLE; Type 0: Not a Combination Product01/03/2011
2NDC:55111-782-9090 in 1 BOTTLE; Type 0: Not a Combination Product01/03/2011
3NDC:55111-782-01100 in 1 BOTTLE; Type 0: Not a Combination Product01/03/2011
4NDC:55111-782-7810 in 1 CARTON01/03/2011
4NDC:55111-782-7910 in 1 BLISTER PACK; Type 0: Not a Combination Product
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 AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Fexofenadine Hydrochloride (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V) Fexofenadine Hydrochloride60 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
magnesium stearate (UNII: 70097M6I30)  
mannitol (UNII: 3OWL53L36A)  
POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
polyethylene glycol 400 (UNII: B697894SGQ)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
ColorPINKScoreno score
ShapeOVALSize5mm
FlavorImprint Code 193;R
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55111-783-3030 in 1 BOTTLE; Type 0: Not a Combination Product01/03/2011
2NDC:55111-783-6060 in 1 BOTTLE; Type 0: Not a Combination Product01/03/2011
3NDC:55111-783-9090 in 1 BOTTLE; Type 0: Not a Combination Product01/03/2011
4NDC:55111-783-01100 in 1 BOTTLE; Type 0: Not a Combination Product01/03/2011
5NDC:55111-783-7810 in 1 CARTON01/03/2011
5NDC:55111-783-7910 in 1 BLISTER PACK; Type 0: Not a Combination Product
6NDC:55111-783-282 in 1 CARTON12/01/2020
66 in 1 BLISTER PACK; Type 0: Not a Combination Product
7NDC:55111-783-244 in 1 CARTON12/01/2020
76 in 1 BLISTER PACK; Type 0: Not a Combination Product
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 AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Fexofenadine Hydrochloride (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V) Fexofenadine Hydrochloride180 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MANNITOL (UNII: 3OWL53L36A)  
POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
ColorPINKScoreno score
ShapeOVALSize7mm
FlavorImprint Code 194;R
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55111-784-301 in 1 CARTON01/03/2011
130 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:55111-784-432 in 1 CARTON01/03/2011
230 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:55111-784-401 in 1 CARTON01/03/2011
340 in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:55111-784-451 in 1 CARTON01/03/2011
445 in 1 BOTTLE; Type 0: Not a Combination Product
5NDC:55111-784-592 in 1 CARTON01/03/2011
560 in 1 BOTTLE; Type 0: Not a Combination Product
6NDC:55111-784-751 in 1 CARTON01/03/2011
670 in 1 BOTTLE; Type 0: Not a Combination Product
7NDC:55111-784-901 in 1 CARTON01/03/2011
790 in 1 BOTTLE; Type 0: Not a Combination Product
8NDC:55111-784-011 in 1 CARTON01/03/2011
8100 in 1 BOTTLE; Type 0: Not a Combination Product
9NDC:55111-784-151 in 1 CARTON01/03/2011
9150 in 1 BOTTLE; Type 0: Not a Combination Product
10NDC:55111-784-181 in 1 CARTON01/03/2011
10180 in 1 BOTTLE; Type 0: Not a Combination Product
11NDC:55111-784-051 in 1 CARTON01/03/2011
11500 in 1 BOTTLE; Type 0: Not a Combination Product
12NDC:55111-784-231 in 1 CARTON01/03/2011
122 in 1 BLISTER PACK; Type 0: Not a Combination Product
13NDC:55111-784-071 in 1 CARTON01/03/2011
135 in 1 BLISTER PACK; Type 0: Not a Combination Product
14NDC:55111-784-352 in 1 CARTON12/01/2021
145 in 1 BLISTER PACK; Type 0: Not a Combination Product
15NDC:55111-784-293 in 1 CARTON01/03/2011
155 in 1 BLISTER PACK; Type 0: Not a Combination Product
16NDC:55111-784-7810 in 1 CARTON01/03/2011
16NDC:55111-784-7910 in 1 BLISTER PACK; Type 0: Not a Combination Product
17NDC:55111-784-283 in 1 CARTON01/03/2011
1715 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07650201/03/2011
Labeler - Dr. Reddy's Laboratories Limited (650562841)
Establishment
NameAddressID/FEIBusiness Operations
Dr. Reddy's Laboratories Limited (FTO III)918608162analysis(55111-784, 55111-782, 55111-783) , manufacture(55111-784, 55111-782, 55111-783)
Establishment
NameAddressID/FEIBusiness Operations
Reed-Lane, Inc.001819879repack(55111-784, 55111-782, 55111-783)
Establishment
NameAddressID/FEIBusiness Operations
Quality Packaging Specialists International, LLC080629831repack(55111-784)
Establishment
NameAddressID/FEIBusiness Operations
Dr. Reddy's Laboratories Louisiana, LLC830397282repack(55111-784)
Establishment
NameAddressID/FEIBusiness Operations
DR. REDDY'S LABORATORIES LIMITED 860037244repack(55111-784, 55111-783) , analysis(55111-783) , manufacture(55111-783)

Revised: 6/2021
Document Id: c8ff984d-35b8-9174-a6ed-5cc49e6bb054
Set id: 864e3052-5787-bf11-9d17-11274ca2304f
Version: 16
Effective Time: 20210624
 
Dr. Reddy's Laboratories Limited