FEXOFENADINE HYDROCHLORIDE- fexofenadine hydrochloride tablet 
RETAIL BUSINESS SERVICES, LLC

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FEXOFENADINE HYDROCHLORIDE TABLETS

Drug Facts

Active ingredient (in each tablet)

Fexofenadine HCl 180 mg

Purpose

Antihistamine

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
 runny nose  sneezing  itchy, watery eyes  itching of the nose or throat

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  do not take more than directed  do not take at
the same time as aluminum or magnesium antacids  do not take with fruit juices (see
Directions)

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek
medical help right away. You may report side effects to FDA at 1-800-FDA-1088.

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 age do not use
 adults 65 years of age and older ask a doctor
 consumers with kidney disease ask a doctor

Drug Facts (continued)

Other information  safety sealed: do not use if printed foil inner
seal on bottle is torn or missing  store between 20º and 25ºC (68º
and 77ºF)  protect from excessive moisture

Inactive ingredients colloidal silicone dioxide, croscarmellose sodium, hypromellose,
magnesium stearate, microcrystalline cellulose, polyethylene
glycol/macrogol, povidone, pregelatinized starch, red iron oxide,
silica, titanium dioxide, yellow iron oxide.

Questions or comments? call +1-888-333-9792

PRINCIPAL DISPLAY PANEL

non-drowsy
FEXOFENADINE
HYDROCHLORIDE
TABLETS USP
180 mg
antihistamine

24 Hour

indoor & outdoor allergy relief
• sneezing • runny nose
• itchy, watery eyes
• itchy nose or throat

image description

FEXOFENADINE HYDROCHLORIDE 
fexofenadine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72476-121
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
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
HYPROMELLOSE 2910 (15 MPA.S) (UNII: 36SFW2JZ0W)  
HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
POVIDONE (UNII: FZ989GH94E)  
STARCH, CORN (UNII: O8232NY3SJ)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColororangeScoreno score
ShapeCAPSULESize17mm
FlavorImprint Code 180
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72476-121-301 in 1 CARTON09/17/2020
130 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21013709/17/2020
Labeler - RETAIL BUSINESS SERVICES, LLC (967989935)

Revised: 9/2020
Document Id: af8425e2-7318-88b7-e053-2995a90a3c1f
Set id: af8425e2-7317-88b7-e053-2995a90a3c1f
Version: 1
Effective Time: 20200917
 
RETAIL BUSINESS SERVICES, LLC