FEXOFENADINE HCL- fexofenadine hcl tablet, film coated 
Strategic Sourcing Services, LLC

----------

Fexofenadine HCl Tablets, 180 mg
ANTIHISTAMINE

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.

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
(1-800-222-1222).

Directions adults and children 12 years and over           : take 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

Other Information
• 
store between 20º and 25ºC (68º and 77ºF)
• 
protect from excessive moisture

Inactive ingredients
colloidal anhydrous silica, colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide red,
iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, purified
water, titanium dioxide

Questions or comments?
833-358-6431

Package and principle display

Image.jpg

FEXOFENADINE HCL 
fexofenadine hcl tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70677-1239
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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE (UNII: FZ989GH94E)  
STARCH, CORN (UNII: O8232NY3SJ)  
WATER (UNII: 059QF0KO0R)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
Colororange (ORANGE (PEACH)) Scoreno score
ShapeCAPSULESize17mm
FlavorImprint Code 180
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70677-1239-1100 in 1 BOTTLE; Type 0: Not a Combination Product02/22/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21013702/22/2024
Labeler - Strategic Sourcing Services, LLC (116956644)

Revised: 3/2024
Document Id: 14055d12-e0a6-618c-e063-6394a90a4442
Set id: 7a49f700-5892-404b-b81a-4a92c1928806
Version: 2
Effective Time: 20240319
 
Strategic Sourcing Services, LLC