FEXOFENADINE- fexofenadine tablet, film coated 
Wockhardt Limited

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Fexofenadine Tablets

Active ingredient (in each tablet)

For 30 mg:

Fexofenadine HCl 30 mg

For 60 mg:

Fexofenadine HCl 60 mg

For 180 mg:

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.

Directions

For 30 mg:

adults and children 12 years of age and over
take two 30 mg tablets with water every 12 hours;
do not take more than 4 tablets in 24 hours
children 6 to under 12 years of age
take one 30 mg tablet with water every 12 hours;
do not take more than 2 tablets in 24 hours
children under 6 years of age
do not use
adults 65 years of age and older
ask a doctor
consumers with kidney disease
ask a doctor

For 60 mg:

adults and children 12 years of age and over
take one 60 mg tablet with water every 12 hours;
do not take more than 2 tablets 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

For 180 mg:

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, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone K-30, talc, titanium dioxide

Questions or comments?

Call toll-free 1-800-346-6854

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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FEXOFENADINE 
fexofenadine tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55648-744
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
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
POVIDONE K30 (UNII: U725QWY32X)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorWHITEScoreno score
ShapeROUND (round) Size7mm
FlavorImprint Code W;30
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55648-744-091 in 1 CARTON
1NDC:55648-744-086 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07911202/08/2012
FEXOFENADINE 
fexofenadine tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55648-982
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
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
POVIDONE K30 (UNII: U725QWY32X)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorWHITEScoreno score
ShapeCAPSULE (Capsule) Size11mm
FlavorImprint Code W;982
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55648-982-092 in 1 CARTON
1NDC:55648-982-086 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07911202/08/2012
FEXOFENADINE 
fexofenadine tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55648-987
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
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
POVIDONE K30 (UNII: U725QWY32X)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorWHITEScoreno score
ShapeCAPSULE (Capsule) Size17mm
FlavorImprint Code W;987
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55648-987-121 in 1 CARTON
130 in 1 BOTTLE
2NDC:55648-987-131 in 1 CARTON
245 in 1 BOTTLE
3NDC:55648-987-142 in 1 CARTON
345 in 1 BOTTLE
4NDC:55648-987-101 in 1 CARTON
4NDC:55648-987-095 in 1 BLISTER PACK
5NDC:55648-987-113 in 1 CARTON
5NDC:55648-987-095 in 1 BLISTER PACK
6NDC:55648-987-052000 in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07911202/08/2012
Labeler - Wockhardt Limited (650069115)
Registrant - Wockhardt Limited (650069115)
Establishment
NameAddressID/FEIBusiness Operations
Wockhardt Limited676257570Manufacture

Revised: 5/2012
Document Id: 865eb588-6553-4222-b98e-3759fab38f2d
Set id: db8d895c-1004-4d5b-bc0d-81f192bfc7b0
Version: 1
Effective Time: 20120508
 
Wockhardt Limited