Fexofenadine Hydrochloride description, usages, side effects, indications, overdosage, supplying and lots more!

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Fexofenadine Hydrochloride

REMEDYREPACK INC.

Major Pharmaceuticals


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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



Fexofenadine Hydrochloride

Fexofenadine Hydrochloride

Fexofenadine Hydrochloride

Fexofenadine HCl TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:52125-570(NDC:0904-6311)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
FEXOFENADINE HYDROCHLORIDE FEXOFENADINE 180 mg

Inactive Ingredients

Ingredient Name Strength
cellulose, microcrystalline
lactose monohydrate
POLYETHYLENE GLYCOLS
MAGNESIUM STEARATE
povidone
talc
CROSCARMELLOSE SODIUM
ferric oxide red
HYPROMELLOSES
FERRIC OXIDE YELLOW
SILICON DIOXIDE
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
white 7 mm W987 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:52125-570-20 100 in 1 VIAL

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079112 2013-05-23


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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