FEXOFENADINE HYDROCHLORIDE - fexofenadine hydrochloride tablet, film coated 
Aurolife Pharma, LLC

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Active ingredient (in each tablet)


For 60 mg:

Fexofenadine HCl USP, 60 mg


For 180 mg:

Fexofenadine HCl USP, 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


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

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 overtake 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



anhydrous lactose, colloidal silicon dioxide, corn starch,croscarmellose sodium, hypromellose, lactose monohydrate, polyethylene glycol 400, pregelatinized corn starch, red iron oxide, stearic acid, titanium dioxide, and yellow iron oxide

Questions or comments?


call toll free 1-866-850-2876 



Principal Display Panel - 60 mg 500's count



NDC 13107-066-05


*Compare to 12 Hour Allegra®
Allergy active ingredient


Fexofenadine Hydrochloride Tablets USP, 60 mg/antihistamine
 
Allergy 

Relief of: 


 Sneezing
 R
unny nose
Itchy, watery eyes
Itchy nose or throat           12 Hour

Indoor & Outdoor Allergies

DO NOT USE IF FOIL SEAL IS TORN OR MISSING

500 Tablets 60 mg each



fexofenadine60mg

Principal Display Panel - 180 mg 500's count

NDC 13107-067-05


*Compare to 24 Hour Allegra®
Allergy active ingredient


Fexofenadine Hydrochloride Tablets USP, 180 mg/antihistamine

Allergy

Relief of:


Sneezing
R
unny nose
Itchy, watery eyes
Itchy nose or throat   24 Hour

Indoor & Outdoor Allergies

DO NOT USE IF FOIL SEAL IS TORN OR MISSING

500 Tablets 180 mg each


Fexo180mg
FEXOFENADINE HYDROCHLORIDE 
fexofenadine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13107-066
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
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
COLLOIDAL SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorORANGE (Peach) Scoreno score
ShapeCAPSULE (Bevel Edge, Biconvex) Size12mm
FlavorImprint Code E;42
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13107-066-051 in 1 CARTON
1500 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20203908/26/2015
FEXOFENADINE HYDROCHLORIDE 
fexofenadine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13107-067
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
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
COLLOIDAL SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorORANGE (Peach) Scoreno score
ShapeCAPSULE (Bevel Edge, Biconvex) Size17mm
FlavorImprint Code E;44
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13107-067-051 in 1 CARTON
1500 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20203911/19/2014
Labeler - Aurolife Pharma, LLC (829084461)
Establishment
NameAddressID/FEIBusiness Operations
Aurolife Pharma, LLC829084461MANUFACTURE(13107-066, 13107-067)

Revised: 8/2015
Document Id: 536dab2f-7586-4d45-b745-99c6cab47743
Set id: bc176016-ebab-4430-82ac-dde96b545194
Version: 2
Effective Time: 20150826
 
Aurolife Pharma, LLC