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Fexofenodine Hydrochloride

Dosage form: tablet, film coated
Ingredients: FEXOFENADINE HYDROCHLORIDE 60mg
Labeler: NCS HealthCare of KY, Inc dba Vangard Labs
NDC Code: 0615-7695

Fexofenadine Hydrochloride Tablets

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

 

FEXOFENODINE HYDROCHLORIDE 
fexofenadine tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0615-7695(NDC:45802-425)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE) FEXOFENADINE HYDROCHLORIDE60 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
CROSCARMELLOSE SODIUM 
HYPROMELLOSES 
FERROSOFERRIC OXIDE 
FERRIC OXIDE YELLOW 
LACTOSE MONOHYDRATE 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOLS 
POVIDONE 
TITANIUM DIOXIDE 
Product Characteristics
ColorORANGE (Peach) Scoreno score
ShapeROUNDSize8mm
FlavorImprint Code 93;7252
Contains    
Packaging
#Item CodePackage Description
1NDC:0615-7695-3930 TABLET, FILM COATED (30 TABLET) in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07644708/08/2011
Labeler - NCS HealthCare of KY, Inc dba Vangard Labs (050052943)
Establishment
NameAddressID/FEIOperations
NCS HealthCare of KY, Inc dba Vangard Labs050052943RELABEL(0615-7695), REPACK(0615-7695)

Revised: 04/2012
Document Id: cb572295-e78c-40b8-8a9b-d5d1b36e7b07
Set id: bbb5dbaa-dc63-4822-82cd-1acf9745f6f4
Version: 2
Effective Time: 20120426
 
NCS HealthCare of KY, Inc dba Vangard Labs

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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