FEXOFENADINE HYDROCHLORIDE- fexofenadine hydrochloride tablet 
Safrel Pharmaceuticals, LLC.

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Fexofenadine HCl Tablets 180 mg

ACTIVE INGREDIENT(S)

Fexofenadine HCl USP 60 mg (for 60 mg)

Fexofenadine HCl USP 180 mg (for 180 mg)

PURPOSE

Antihistamine

USE(S)

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 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

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 (for 60 mg)
take one 180 mg tablet with water once a day; do not take more than 1 tablet in 24 hours (for 180 mg) 
 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, pregelatinized starch (maize), red iron oxide, stearic acid, titanium dioxide and yellow iron oxide

QUESTIONS OR COMMENTS

Contact 1-844-384-3723 Mon-Fri 8:00 AM EST to 5:00 PM PST



Distributed By:

Safrel Pharmaceuticals, LLC
Bridgewater, NJ 08807

PRINCIPAL DISPLAY PANEL

NDC 71309-091-01 - 100 Count

Fexo

FEXOFENADINE HYDROCHLORIDE 
fexofenadine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71309-091
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
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STARCH, CORN (UNII: O8232NY3SJ)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
Product Characteristics
Colororange (PEACH) Scoreno score
ShapeOVAL (Capsule-shaped) Size17mm
FlavorImprint Code G6
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71309-091-01100 in 1 BOTTLE; Type 0: Not a Combination Product01/31/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21107501/03/2021
Labeler - Safrel Pharmaceuticals, LLC. (080566287)

Revised: 3/2023
Document Id: f7f18cee-5649-13c4-e053-6294a90ad4a8
Set id: d6120f56-ab28-2696-e053-2995a90adf47
Version: 2
Effective Time: 20230328
 
Safrel Pharmaceuticals, LLC.