FEXOFENADINE HYDROCHLORIDE- fexofenadine hcl tablet 
REMEDYREPACK INC.

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Major Pharmaceuticals

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.

 

DOSAGE & ADMINISTRATION

 adults and children 12 years of age 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

 

STORAGE AND HANDLING

  • store at 20° to 25°C (68° to 77°F)
  • protect from excessive moisture

 

INACTIVE INGREDIENT

colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide red, iron oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone K-30, talc, titanium dioxide

 

OTC - QUESTIONS

Call: 1-800-616-2471

 

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

DRUG: Fexofenadine Hydrochloride


GENERIC: Fexofenadine HCl


DOSAGE: TABLET


ADMINSTRATION: ORAL


NDC: 52125-570-20


ACTIVE INGREDIENT(S):

  • FEXOFENADINE HYDROCHLORIDE 180mg in 1


INACTIVE INGREDIENT(S):

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


COLOR: white


SHAPE: CAPSULE


SCORE: No score


SIZE: 7 mm


IMPRINT: W987


PACKAGING: 100 in 1 VIAL



MM1

MM2

FEXOFENADINE HYDROCHLORIDE 
fexofenadine hcl tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:52125-570(NDC:0904-6311)
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)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POVIDONE (UNII: FZ989GH94E)  
TALC (UNII: 7SEV7J4R1U)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorwhiteScoreno score
ShapeCAPSULE (TABLET) Size7mm
FlavorImprint Code W987
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52125-570-20100 in 1 VIAL; Type 0: Not a Combination Product10/01/201310/15/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07911210/01/201310/15/2014
Labeler - REMEDYREPACK INC. (829572556)

Revised: 1/2017
 
REMEDYREPACK INC.