FEXOFENODINE HYDROCHLORIDE- fexofenadine tablet, film coated 
NCS HealthCare of KY, LLC dba Vangard Labs

----------

Fexofenadine Hydrochloride Tablets 60mg

Active ingredient (in each tablet)

Fexofenadine HCI 60mg 

Purpose

Antihistamine 

Use(s)

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

  • runny nose
  • itchy, watery eyes
  • sneezing
  • 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 of age and overtake one 60 mg tablet with water every 12 hours; do not take more than 2 tablets in 24 hours
children under 12 years of agedo not use
adults 65 years of age and olderask a doctor

Other information

  • do not use if printed foil under cap is broken or missing
  • store at 20°-25°C (68°-77°F)
  • protect from excessive moisture
  • this product meets the requirements of USP Dissolution Test 3

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, titanium dioxide 

Questions or Comments?

 1-800-719-9260

Principal Display Panel

 Principal Display Panel-Fexofenadine Hydrochloride Tabs 60mg

FEXOFENODINE HYDROCHLORIDE 
fexofenadine tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0615-7695(NDC:45802-425)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FEXOFENADINE HYDROCHLORIDE (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V) FEXOFENADINE HYDROCHLORIDE60 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE (UNII: FZ989GH94E)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
Colororange (Peach) Scoreno score
ShapeROUNDSize8mm
FlavorImprint Code 93;7252
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0615-7695-3930 in 1 BLISTER PACK; Type 0: Not a Combination Product04/19/201208/31/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07644708/08/201108/31/2014
Labeler - NCS HealthCare of KY, LLC dba Vangard Labs (050052943)
Establishment
NameAddressID/FEIBusiness Operations
NCS HealthCare of KY, LLC dba Vangard Labs050052943repack(0615-7695)

Revised: 5/2021
 
NCS HealthCare of KY, LLC dba Vangard Labs