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

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Drug Facts

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

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

Fexofenadine Hydrochloride Tablets 60 mg Bottle Label Front

Fexofenadine HCl Tablet, USP 60 mg Bottle Lable - Back of Front Layer

Fexofenadine Hydrochloride Tablets 60 mg Bottle Label Back

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

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 Tablets 180 mg Bottle Label Front

Fexofenadine HCl Tablets, USP 180 mg Bottle Label - Back of Front Layer

Fexofenadine Hydrochloride Tablets 180 mg Bottle Label Back

FEXOFENADINE HYDROCHLORIDE
fexofenadine tablet, film coated

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

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

Ingredient Name	Strength
Inactive Ingredients
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)
CROSPOVIDONE (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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0378-0781-91	60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/25/2011	02/28/2022
2	NDC:0378-0781-05	500 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/25/2011	12/31/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA077081	08/25/2011	02/28/2022

FEXOFENADINE HYDROCHLORIDE
fexofenadine tablet, film coated

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

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

Ingredient Name	Strength
Inactive Ingredients
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)
CROSPOVIDONE (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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0378-0782-93	30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/25/2011	02/28/2022
2	NDC:0378-0782-05	500 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/25/2011	12/31/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA077081	08/25/2011	02/28/2022

Labeler - Mylan Pharmaceuticals Inc. (059295980)

Revised: 1/2020

Document Id: f35905cb-7f58-41f1-a851-403032789d14

Set id: 6ce175fc-d9cd-467f-b196-83a6fa070217

Version: 7

Effective Time: 20200127

Mylan Pharmaceuticals Inc.