FEXOFENADINE HYDROCHLORIDE tablet

Fexofenadine hydrochloride by

Drug Labeling and Warnings

Fexofenadine hydrochloride by is a Otc medication manufactured, distributed, or labeled by Dr. Reddy's Laboratories Limited, Dr. Reddy's Laboratories Limited (FTO III), Reed-Lane, Inc., Quality Packaging Specialists International, LLC, Dr. Reddy's Laboratories Louisiana, LLC, DR. REDDY'S LABORATORIES LIMITED . Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient(s)

Fexofenadine HCl USP, 180 mg

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 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 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

Other information

• safety sealed: do not use if carton is opened or if printed foil inner seal on bottle is torn or missing
• store between 20° and 25°C (68° and 77°F)
• protect from excessive moisture
• this product meets the requirements of USP Dissolution Test 4

Inactive ingredients

colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C Red no. 40, hypromellose, iron oxide black, magnesium stearate, mannitol, polyethylene glycol, powder cellulose and titanium dioxide

Questions?

Call 1-888-375-3784

PACKAGE LABEL PRINCIPAL DISPLAY PANEL SECTION

Bottle label:

PRINCIPAL DISPLAY PANEL

Fexofenadine HCL Tablets, 30 mg Carton:

PRINCIPAL DISPLAY PANEL

Fexofenadine HCL Tablets USP, 60 mg Carton:

PRINCIPAL DISPLAY PANEL

Fexofenadine HCL Tablets USP, 180 mg Carton Label:

INGREDIENTS AND APPEARANCE

FEXOFENADINE HYDROCHLORIDE 
fexofenadine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55111-782
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Fexofenadine Hydrochloride (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V)	Fexofenadine Hydrochloride	30 mg

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
magnesium stearate (UNII: 70097M6I30)
mannitol (UNII: 3OWL53L36A)
POWDERED CELLULOSE (UNII: SMD1X3XO9M)
FD&C RED NO. 40 (UNII: WZB9127XOA)
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
polyethylene glycol 400 (UNII: B697894SGQ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	PINK	Score	no score
Shape	OVAL	Size	4mm
Flavor		Imprint Code	192;R
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55111-782-30	30 in 1 BOTTLE; Type 0: Not a Combination Product	01/03/2011
2	NDC: 55111-782-90	90 in 1 BOTTLE; Type 0: Not a Combination Product	01/03/2011
3	NDC: 55111-782-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	01/03/2011
4	NDC: 55111-782-78	10 in 1 CARTON	01/03/2011
4	NDC: 55111-782-79	10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA076502	01/03/2011

FEXOFENADINE HYDROCHLORIDE 
fexofenadine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55111-783
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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
magnesium stearate (UNII: 70097M6I30)
mannitol (UNII: 3OWL53L36A)
POWDERED CELLULOSE (UNII: SMD1X3XO9M)
FD&C RED NO. 40 (UNII: WZB9127XOA)
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
polyethylene glycol 400 (UNII: B697894SGQ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	PINK	Score	no score
Shape	OVAL	Size	5mm
Flavor		Imprint Code	193;R
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55111-783-30	30 in 1 BOTTLE; Type 0: Not a Combination Product	01/03/2011
2	NDC: 55111-783-60	60 in 1 BOTTLE; Type 0: Not a Combination Product	01/03/2011
3	NDC: 55111-783-90	90 in 1 BOTTLE; Type 0: Not a Combination Product	01/03/2011
4	NDC: 55111-783-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	01/03/2011
5	NDC: 55111-783-78	10 in 1 CARTON	01/03/2011
5	NDC: 55111-783-79	10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA076502	01/03/2011

FEXOFENADINE HYDROCHLORIDE 
fexofenadine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55111-784
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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MANNITOL (UNII: 3OWL53L36A)
POWDERED CELLULOSE (UNII: SMD1X3XO9M)
FD&C RED NO. 40 (UNII: WZB9127XOA)
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	PINK	Score	no score
Shape	OVAL	Size	7mm
Flavor		Imprint Code	194;R
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55111-784-30	1 in 1 CARTON	01/03/2011
1		30 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 55111-784-43	2 in 1 CARTON	01/03/2011
2		30 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 55111-784-40	1 in 1 CARTON	01/03/2011
3		40 in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC: 55111-784-45	1 in 1 CARTON	01/03/2011
4		45 in 1 BOTTLE; Type 0: Not a Combination Product
5	NDC: 55111-784-59	2 in 1 CARTON	01/03/2011
5		60 in 1 BOTTLE; Type 0: Not a Combination Product
6	NDC: 55111-784-75	1 in 1 CARTON	01/03/2011
6		70 in 1 BOTTLE; Type 0: Not a Combination Product
7	NDC: 55111-784-90	1 in 1 CARTON	01/03/2011
7		90 in 1 BOTTLE; Type 0: Not a Combination Product
8	NDC: 55111-784-01	1 in 1 CARTON	01/03/2011
8		100 in 1 BOTTLE; Type 0: Not a Combination Product
9	NDC: 55111-784-15	1 in 1 CARTON	01/03/2011
9		150 in 1 BOTTLE; Type 0: Not a Combination Product
10	NDC: 55111-784-18	1 in 1 CARTON	01/03/2011
10		180 in 1 BOTTLE; Type 0: Not a Combination Product
11	NDC: 55111-784-05	1 in 1 CARTON	01/03/2011
11		500 in 1 BOTTLE; Type 0: Not a Combination Product
12	NDC: 55111-784-23	1 in 1 CARTON	01/03/2011
12		2 in 1 BLISTER PACK; Type 0: Not a Combination Product
13	NDC: 55111-784-07	1 in 1 CARTON	01/03/2011
13		5 in 1 BLISTER PACK; Type 0: Not a Combination Product
14	NDC: 55111-784-29	3 in 1 CARTON	01/03/2011
14		5 in 1 BLISTER PACK; Type 0: Not a Combination Product
15	NDC: 55111-784-78	10 in 1 CARTON	01/03/2011
15	NDC: 55111-784-79	10 in 1 BLISTER PACK; Type 0: Not a Combination Product
16	NDC: 55111-784-28	3 in 1 CARTON	01/03/2011
16		15 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA076502	01/03/2011

Labeler - Dr. Reddy's Laboratories Limited (650562841)

Establishment
Name	Address	ID/FEI	Business Operations
Dr. Reddy's Laboratories Limited (FTO III)		918608162	analysis(55111-784, 55111-782, 55111-783) , manufacture(55111-784, 55111-782, 55111-783)

Establishment
Name	Address	ID/FEI	Business Operations
Reed-Lane, Inc.		001819879	repack(55111-784, 55111-782, 55111-783)

Establishment
Name	Address	ID/FEI	Business Operations
Legacy Pharmaceutical Packaging, LLC		143213275	repack(55111-784)

Establishment
Name	Address	ID/FEI	Business Operations
Quality Packaging Specialists International, LLC		080629831	repack(55111-784)

Establishment
Name	Address	ID/FEI	Business Operations
Dr. Reddy's Laboratories Louisiana, LLC		830397282	repack(55111-784)

Establishment
Name	Address	ID/FEI	Business Operations
DR. REDDY'S LABORATORIES LIMITED		860037244	repack(55111-784)