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fexofenadine hydrochloride

REMEDYREPACK INC.

Perrigo Fexofenadine Hydrochloride Tablets, 180 mg Drug Facts


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. (1-800-222-1222)

 

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

  • 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: 49349-890-50


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: 40 in 1 BOTTLE




fexofenadine hydrochloride

fexofenadine hydrochloride

fexofenadine hydrochloride

fexofenadine hydrochloride TABLET, FILM COATED

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:49349-890(NDC:45802-571)
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
ferric oxide red
POLYETHYLENE GLYCOLS
MAGNESIUM STEARATE
povidone
titanium dioxide
CROSCARMELLOSE SODIUM
FERROSOFERRIC OXIDE
HYPROMELLOSES
FERRIC OXIDE YELLOW
lactose monohydrate
SILICON DIOXIDE

Product Characteristics

Color Size Imprint Code Shape
orange 12 mm 93;7253 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49349-890-50 40 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076447 2013-12-04


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Be sure to consult your doctor before taking any medication!
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