FEXOFENADINE HYDROCHLORIDE - fexofenadine hydrochloride tablet, film coated 
Aurohealth LLC

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Active ingredient(in each tablet)


Fexofenadine HCl USP, 180 mg

Fexofenadine HCl USP, 60 mg


Purpose


Antihistamine

Uses


temporarily relieves these symptoms due to hay fever or other upper resporatory 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




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 agedo not use
adults 65 years of age and olderask a doctor
consumers with kidney diseaseask a doctor

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



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

Questions or comments?


 call 1-855-274-4122

Principal Display Panel



NDC 58602-711-19

*Compare to 24 Hour Allegra®
Allergy active ingrediant

Original Prescription Strength Non-Drowsy


Fexofenadine Hydrochloride Tablets USP, 180 mg/antihistamine
 
Allergy
Indoor & Outdoor Allergies

24 Hours Relief of: 


 Sneezing 
 R
unny nose
Itchy, Watery Eyes
Itchy Nose or Throat


DO NOT USE IF FOIL SEAL IS TORN OR MISSING

90 Tablets 180 mg each


Principal Display panel-180 mg-90s count



Principal Display Panel




NDC 58602-710-40

*Compare to 12 Hour Allegra®
Allergy active ingredient

Original Prescription Strength Non-Drowsy


Fexofenadine Hydrochloride Tablets USP, 60 mg/antihistamine
 
Allergy 
Indoor & Outdoor Allergies

12 Hours Relief of: 


 Sneezing 
 R
unny nose
Itchy, Watery Eyes
Itchy Nose or Throat


DO NOT USE IF FOIL SEAL IS TORN OR MISSING 

500 Tablets 60 mg each



fexofenadinehcl

Principal Display Panel

NDC 58602-710-40

*Compare to 12 Hour Allegra®
Allergy active ingredient

Original Prescription Strength Non-Drowsy


Fexofenadine Hydrochloride Tablets USP, 60 mg/antihistamine
 
Allergy 
Indoor & Outdoor Allergies

12 Hours Relief of: 


 Sneezing 
 R
unny nose
Itchy, Watery Eyes
Itchy Nose or Throat


DO NOT USE IF FOIL SEAL IS TORN OR MISSING 

12 Tablets 60 mg each

fexo-fig3

FEXOFENADINE HYDROCHLORIDE 
fexofenadine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-711
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)  
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:58602-711-191 in 1 CARTON01/15/2015
190 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:58602-711-211 in 1 CARTON01/15/2015
2100 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20203901/15/2015
FEXOFENADINE HYDROCHLORIDE 
fexofenadine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-710
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)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
STARCH, 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,Bioconvex) Size12mm
FlavorImprint Code E;42
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58602-710-401 in 1 CARTON; Type 0: Not a Combination Product10/05/2016
2NDC:58602-710-751 in 1 CARTON; Type 0: Not a Combination Product10/05/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20203910/05/2016
Labeler - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
Aurolife Pharma, LLC829084461MANUFACTURE(58602-710, 58602-711)

Revised: 9/2019
Document Id: 89f401d2-5303-4773-93b9-ef63772ce9dc
Set id: a02e680f-60f3-41cc-91df-0fcd76fe36f6
Version: 5
Effective Time: 20190910
 
Aurohealth LLC