FEXOFENADINE HYDROCHLORIDE- fexofenadine hydrochloride tablet, film coated 
REMEDYREPACK INC.

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Perrigo Fexofenadine Hydrochloride Tablets, 180 mg Drug Facts

OTC - ACTIVE INGREDIENT

Fexofenadine HCl 180 mg

 

OTC - PURPOSE

Antihistamine

 

INDICATIONS & USAGE

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

if you have ever had an allergic reaction to this product or any of its ingredients.

 

kidney disease. Your doctor should determine if you need a different dose.

 

  • 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)

 

an allergic reaction to this product occurs. Seek medical help right away.

 

ask a health professional before use.

 

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

 

DOSAGE & ADMINISTRATION

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 agedo not use
adults 65 years of age and olderask a doctor
consumers with kidney diseaseask a doctor

 

STORAGE AND HANDLING

  • 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 INGREDIENT

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

 

OTC - QUESTIONS

1-800-719-9260

 

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

DRUG: fexofenadine hydrochloride


GENERIC: fexofenadine hydrochloride


DOSAGE: TABLET, FILM COATED


ADMINSTRATION: ORAL


NDC: 49349-890-20


ACTIVE INGREDIENT(S):

  • FEXOFENADINE HYDROCHLORIDE 180mg in 1


INACTIVE INGREDIENT(S):

  • CELLULOSE, MICROCRYSTALLINE
  • FERRIC OXIDE RED
  • POLYETHYLENE GLYCOLS
  • MAGNESIUM STEARATE
  • POVIDONE
  • TITANIUM DIOXIDE
  • CROSCARMELLOSE SODIUM
  • FERROSOFERRIC OXIDE
  • HYPROMELLOSES
  • FERRIC OXIDE YELLOW
  • LACTOSE MONOHYDRATE
  • SILICON DIOXIDE


COLOR: orange


SHAPE: ROUND


SCORE: No score


SIZE: 12 mm


IMPRINT: 93;7253


PACKAGING: 100 in 1 VIAL



MM1

MM2

FEXOFENADINE HYDROCHLORIDE 
fexofenadine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:49349-890(NDC:45802-571)
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
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POVIDONE (UNII: FZ989GH94E)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Product Characteristics
ColororangeScoreno score
ShapeROUND (TABLET, FILM COATED) Size12mm
FlavorImprint Code 93;7253
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49349-890-20100 in 1 VIAL; Type 0: Not a Combination Product01/14/201304/11/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07644701/14/201304/11/2016
Labeler - REMEDYREPACK INC. (829572556)

Revised: 1/2017
 
REMEDYREPACK INC.