FEXOFENADINE HYDROCHLORIDE- fexofenadine hydrochloride tablet, film coated 
Mylan Pharmaceuticals Inc.

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Drug Facts

Active ingredient (in each tablet)

Fexofenadine hydrochloride USP, 30 mg

Purpose

Antihistamine

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 overtake 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 agetake one 30 mg tablet with water every 12 hours; do not take more than 2 tablets in 24 hours
children under 6 years of agedo not use
adults 65 years of age and olderask a doctor
consumers with kidney diseaseask a doctor

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 - 30 mg

NDC 0378-0780-01

Original Prescription Strength     Non-Drowsy

Children’s

Fexofenadine HCl
Tablets, USP

30 mg

Allergy

Ages 6 Years
and Older

Antihistamine
Indoor & Outdoor Allergies
12 Hour Relief of:

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

100 TABLETS

RM-AR0780A

Fexofenadine Hydrochloride Tablets 30 mg Bottles - Front Layer
Fexofenadine Hydrochloride Tablets 30 mg Bottles - Back of Front Layer 2
Fexofenadine Hydrochloride Tablets 30 mg Bottles - Base Layer

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

60 TABLETS

RM-AR0781D

Directions
adults and children 12 years of age and overtake one 60 mg tablet with water every 12 hours; do not take more than 2 tablets in 24 hours
children under 12 years of agedo not use
adults 65 years of age and olderask a doctor
consumers with kidney diseaseask a doctor
Fexofenadine Hydrochloride Tablets 60 mg Bottles - Front Layer
Fexofenadine Hydrochloride Tablets 60 mg Bottles - Back of Front Layer 2
Fexofenadine Hydrochloride Tablets 60 mg Bottles - Base Layer

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

30 TABLETS

RM-AR0782H

Directions
adults and children 12 years of age and overtake one 180 mg tablet with water once a day; do not take more than 1 tablet in 24 hours
children under 12 years of agedo not use
adults 65 years of age and olderask a doctor
consumers with kidney diseaseask a doctor
Fexofenadine Hydrochloride Tablets 180 mg Bottles - Front Layer
Fexofenadine Hydrochloride Tablets 180 mg Bottles - Back of Front Layer 2
Fexofenadine Hydrochloride Tablets 180 mg Bottles - Base Layer
FEXOFENADINE HYDROCHLORIDE 
fexofenadine tablet, film coated
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0378-0780
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE) FEXOFENADINE HYDROCHLORIDE30 mg
Inactive Ingredients
Ingredient NameStrength
BUTYLATED HYDROXYANISOLE 
CROSPOVIDONE 
FD&C BLUE NO. 1 
HYPROMELLOSES 
LACTOSE MONOHYDRATE 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYDEXTROSE 
POLYETHYLENE GLYCOL 
POLYSORBATE 80 
POVIDONE 
SODIUM LAURYL SULFATE 
TITANIUM DIOXIDE 
TRIACETIN 
Product Characteristics
ColorBLUEScoreno score
ShapeROUNDSize6mm
FlavorImprint Code M;752
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0378-0780-01100 in 1 BOTTLE, PLASTIC
2NDC:0378-0780-05500 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07708107/30/2011
FEXOFENADINE HYDROCHLORIDE 
fexofenadine tablet, film coated
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0378-0781
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE) FEXOFENADINE HYDROCHLORIDE60 mg
Inactive Ingredients
Ingredient NameStrength
BUTYLATED HYDROXYANISOLE 
CROSPOVIDONE 
FD&C BLUE NO. 1 
HYPROMELLOSES 
LACTOSE MONOHYDRATE 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYDEXTROSE 
POLYETHYLENE GLYCOL 
POLYSORBATE 80 
POVIDONE 
SODIUM LAURYL SULFATE 
TITANIUM DIOXIDE 
TRIACETIN 
Product Characteristics
ColorBLUEScoreno score
ShapeROUNDSize8mm
FlavorImprint Code M;753
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0378-0781-9160 in 1 BOTTLE, PLASTIC
2NDC:0378-0781-05500 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07708107/30/2011
FEXOFENADINE HYDROCHLORIDE 
fexofenadine tablet, film coated
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0378-0782
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE) FEXOFENADINE HYDROCHLORIDE180 mg
Inactive Ingredients
Ingredient NameStrength
BUTYLATED HYDROXYANISOLE 
CROSPOVIDONE 
FD&C BLUE NO. 1 
HYPROMELLOSES 
LACTOSE MONOHYDRATE 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYDEXTROSE 
POLYETHYLENE GLYCOL 
POLYSORBATE 80 
POVIDONE 
SODIUM LAURYL SULFATE 
TITANIUM DIOXIDE 
TRIACETIN 
Product Characteristics
ColorBLUEScoreno score
ShapeOVAL (caplet-shaped) Size18mm
FlavorImprint Code M;755
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0378-0782-9330 in 1 BOTTLE, PLASTIC
2NDC:0378-0782-05500 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07708107/30/2011
Labeler - Mylan Pharmaceuticals Inc. (059295980)

Revised: 6/2011
 
Mylan Pharmaceuticals Inc.