FEXOFENADINE HYDROCHLORIDE- fexofenadine tablet, film coated

Fexofenadine Hydrochloride by

Drug Labeling and Warnings

Fexofenadine Hydrochloride by is a Otc medication manufactured, distributed, or labeled by Mylan Pharmaceuticals Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each tablet)

Fexofenadine hydrochloride USP, 60 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 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

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
• Meets USP Dissolution Test 2

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

Non-Drowsy

Fexofenadine HCl
Tablets, USP

60 mg

Allergy

12 HR

Antihistamine
Indoor/Outdoor Allergy Relief

• Sneezing
• Runny Nose
• Itchy, Watery Eyes
• Itchy Nose or Throat

RM-AR0781D3     60 Tablets

• 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

Non-Drowsy

Fexofenadine HCl
Tablets, USP

180 mg

Allergy

24 HR

Antihistamine
Indoor/Outdoor Allergy Relief

• Sneezing
• Runny Nose
• Itchy, Watery Eyes
• Itchy Nose or Throat

RM-AR0782H3     30 Tablets

• 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

INGREDIENTS AND APPEARANCE

FEXOFENADINE HYDROCHLORIDE 
fexofenadine tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0378-0781
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
FEXOFENADINE HYDROCHLORIDE (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V)	FEXOFENADINE HYDROCHLORIDE	60 mg

Inactive Ingredients
Ingredient Name	Strength
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)
CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYDEXTROSE (UNII: VH2XOU12IE)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIACETIN (UNII: XHX3C3X673)

Product Characteristics
Color	BLUE	Score	no score
Shape	ROUND	Size	8mm
Flavor		Imprint Code	M;753
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0378-0781-91	60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/25/2011
2	NDC: 0378-0781-05	500 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/25/2011

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

FEXOFENADINE HYDROCHLORIDE 
fexofenadine tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0378-0782
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
FEXOFENADINE HYDROCHLORIDE (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V)	FEXOFENADINE HYDROCHLORIDE	180 mg

Inactive Ingredients
Ingredient Name	Strength
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)
CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYDEXTROSE (UNII: VH2XOU12IE)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIACETIN (UNII: XHX3C3X673)

Product Characteristics
Color	BLUE	Score	no score
Shape	OVAL (caplet-shaped)	Size	18mm
Flavor		Imprint Code	M;755
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0378-0782-93	30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/25/2011
2	NDC: 0378-0782-05	500 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/25/2011

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

Labeler - Mylan Pharmaceuticals Inc. (059295980)