FEXOFENADINE HYDROCHLORIDE - fexofenadine hydrochloride tablet, film coated 
Ahold U.S.A., Inc

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Active ingredient(in each tablet)


Fexofenadine HCl USP, 180 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

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 (180 mg 15 ct)


NDC 60000-409-53

*Compare to Active Ingredient in 24 Hour Allegra®
Original Prescription Strength Non-Drowsy

Fexofenadine Hydrochloride Tablets USP, 180 mg antihistamine
24 hour relief of Indoor & Outdoor Allergies:
Sneezing 
R
unny nose
Itchy, Watery Eyes
Itchy Nose or Throat

fexo10mg15ct.jpg

Principal Display Panel (180 mg 30 ct)


NDC 60000-409-30

*Compare to Active Ingredient in 24 Hour Allegra®
Original Prescription Strength Non-Drowsy

Fexofenadine Hydrochloride Tablets USP, 180 mg antihistamine
24 hour relief of Indoor & Outdoor Allergies:
Sneezing 
R
unny nose
Itchy, Watery Eyes
Itchy Nose or Throat
fexo180mg30ct.jpg

Principal Display Panel (180 mg 45 ct)


NDC 60000-409-45

*Compare to Active Ingredient in 24 Hour Allegra®
Original Prescription Strength Non-Drowsy

Fexofenadine Hydrochloride Tablets USP, 180 mg antihistamine
24 hour relief of Indoor & Outdoor Allergies:
Sneezing 
R
unny nose
Itchy, Watery Eyes
Itchy Nose or Throat

fexo180mg45ct.jpg

Principal Display Panel (180 mg 45 ct+ 50% bonus)


NDC 60000-409-48

*Compare to Active Ingredient in 24 Hour Allegra®
Original Prescription Strength Non-Drowsy

Fexofenadine Hydrochloride Tablets USP, 180 mg antihistamine
24 hour relief of Indoor & Outdoor Allergies:
Sneezing 
R
unny nose
Itchy, Watery Eyes
Itchy Nose or Throat
fexo180mg45ctbonus.jpg

FEXOFENADINE HYDROCHLORIDE 
fexofenadine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60000-409
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:60000-409-481 in 1 CARTON01/15/2015
145 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:60000-409-301 in 1 CARTON01/15/2015
230 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:60000-409-531 in 1 CARTON01/15/2015
315 in 1 BLISTER PACK; Type 0: Not a Combination Product
4NDC:60000-409-451 in 1 CARTON01/15/2015
445 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20203901/15/2015
Labeler - Ahold U.S.A., Inc (188910863)
Establishment
NameAddressID/FEIBusiness Operations
Aurolife Pharma, LLC829084461MANUFACTURE(60000-409)

Revised: 9/2019
Document Id: df192c93-2573-457f-9583-f94557ed028e
Set id: ce7e5fc4-630a-4184-a7a8-9d877bfbadc4
Version: 2
Effective Time: 20190911
 
Ahold U.S.A., Inc