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

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Fexofenodine Hydrochloride

NCS HealthCare of KY, Inc dba Vangard Labs

Fexofenadine Hydrochloride Tablets


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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. 

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 over take one 60 mg tablet with water every 12 hours; do not take more than 2 tablets in 24 hours
children under 12 years of age do not use
adults 65 years of age and older ask a doctor

Fexofenodine Hydrochloride 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

Fexofenodine Hydrochloride

Fexofenadine TABLET, FILM COATED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0615-7695(NDC:45802-425)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
FEXOFENADINE HYDROCHLORIDE FEXOFENADINE 60 mg

Inactive Ingredients

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

Product Characteristics

Color Size Imprint Code Shape
ORANGE (Peach) 8 mm 93;7252 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0615-7695-39 30 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076447 2011-08-08


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