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

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Fexofenadine Hydrochloride

Mylan Pharmaceuticals Inc.

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each tablet)

Fexofenadine hydrochloride USP, 30 mg

Purpose

Antihistamine

Fexofenadine Hydrochloride Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

  • •runny nose
  • •sneezing
  • •itchy, watery eyes
  • •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.

If pregnant or breast-feeding,

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.

Directions

adults and children 12 years of age and over

take two 30 mg tablets with water every 12 hours; do not take more than 4 tablets in 24 hours

children 6 to under 12 years of age

take one 30 mg tablet with water every 12 hours; do not take more than 2 tablets in 24 hours

children under 6 years of age

do not use

adults 65 years of age and older

ask a doctor

consumers with kidney disease

ask a doctor

Fexofenadine Hydrochloride Other information

  • •Tamper Evident: do not use if foil seal under cap is missing, open or broken.
  • •store between 20° to 25°C (68° to 77°F)
  • •protect from excessive moisture

Inactive ingredients

Butylated hydroxyanisole, crospovidone, FD&C Blue No. 1 Aluminum Lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, polysorbate 80, povidone, sodium lauryl sulfate, titanium dioxide and triacetin.

Questions or comments?

Call 1-877-446-3679 (1-877-4-INFO-RX)

Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.

PRINCIPAL DISPLAY PANEL - 60 mg

NDC 0378-0781-91

Original Prescription Strength     Non-Drowsy

Fexofenadine HCl
Tablets, USP

60 mg

Allergy

Antihistamine
Indoor & Outdoor Allergies

12 Hour Relief of:

  • runny nose
  • sneezing
  • itchy, watery eyes
  • itchy nose or throat

RM-AR0781D1     60 Tablets

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

consumers with kidney disease

ask a doctor

PRINCIPAL DISPLAY PANEL - 180 mg

NDC 0378-0782-93

Original Prescription Strength     Non-Drowsy

Fexofenadine HCl
Tablets, USP

180 mg

Allergy

Antihistamine
Indoor & Outdoor Allergies

24 Hour Relief of:

  • runny nose
  • sneezing
  • itchy, watery eyes
  • itchy nose or throat

RM-AR0782H1     30 Tablets

Directions

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

Fexofenadine Hydrochloride

fexofenadine TABLET, FILM COATED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0378-0781
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
BUTYLATED HYDROXYANISOLE
CROSPOVIDONE
FD&C BLUE NO. 1
HYPROMELLOSES
lactose monohydrate
MAGNESIUM STEARATE
cellulose, microcrystalline
POLYDEXTROSE
POLYETHYLENE GLYCOLS
polysorbate 80
POVIDONES
SODIUM LAURYL SULFATE
titanium dioxide
triacetin

Product Characteristics

Color Size Imprint Code Shape
BLUE 8 mm M;753 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0378-0781-91 60 in 1 BOTTLE, PLASTIC
2 NDC:0378-0781-05 500 in 1 BOTTLE, PLASTIC

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077081 2011-08-25


Fexofenadine Hydrochloride

fexofenadine TABLET, FILM COATED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0378-0782
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
BUTYLATED HYDROXYANISOLE
CROSPOVIDONE
FD&C BLUE NO. 1
HYPROMELLOSES
lactose monohydrate
MAGNESIUM STEARATE
cellulose, microcrystalline
POLYDEXTROSE
POLYETHYLENE GLYCOLS
polysorbate 80
POVIDONES
SODIUM LAURYL SULFATE
titanium dioxide
triacetin

Product Characteristics

Color Size Imprint Code Shape
BLUE 18 mm M;755 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0378-0782-93 30 in 1 BOTTLE, PLASTIC
2 NDC:0378-0782-05 500 in 1 BOTTLE, PLASTIC

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077081 2011-08-25


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Be sure to consult your doctor before taking any medication!
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