FEXOFENADINE HYDROCHLORIDE - fexofenadine hydrochloride tablet, film coated 
Sam's West 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 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




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



NDC 68196-976-91

Original Prescription Strength



Fexofenadine Hydrochloride Tablets USP, 180 mg/antihistamine
 

Indoor & Outdoor Allergies
Non-Drowsy

24 Hours Relief of: 


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



150 Tablets 180 mg each





Principle Display Panel-180 mg 150s count
FEXOFENADINE HYDROCHLORIDE 
fexofenadine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68196-976
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:68196-976-911 in 1 CARTON01/15/2015
1150 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 - Sam's West Inc (051957769)
Establishment
NameAddressID/FEIBusiness Operations
Aurolife Pharma, LLC829084461MANUFACTURE(68196-976)

Revised: 9/2019
Document Id: 52d0f22a-fe82-4725-aba6-f95a44740285
Set id: 53d6c830-060b-4427-8acc-51a6c50f8a11
Version: 2
Effective Time: 20190910
 
Sam's West Inc