FEXOFENADINE HYDROCHLORIDE tablet

Fexofenadine hydrochloride by

Drug Labeling and Warnings

Fexofenadine hydrochloride by is a Otc medication manufactured, distributed, or labeled by BluePoint Laboratories, DR. REDDY'S LABORATORIES LIMITED, Dr. Reddy's Laboratories Limited (FTO III). 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 (1-800-222-1222)..

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

PRINCIPAL DISPLAY PANEL

Fexofenadine HCL Tablets, 60 mg Carton:

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FEXOFENADINE HYDROCHLORIDE 
fexofenadine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68001-439
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	4mm
Flavor		Imprint Code	193;R
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68001-439-00	1 in 1 CARTON	06/19/2020
1		100 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA076502	06/19/2020

FEXOFENADINE HYDROCHLORIDE 
fexofenadine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68001-440
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	5mm
Flavor		Imprint Code	194;R
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68001-440-00	1 in 1 CARTON	06/19/2020
1		100 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 68001-440-04	1 in 1 CARTON	06/19/2020
2		30 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA076502	06/19/2020

Labeler - BluePoint Laboratories (985523874)

Establishment
Name	Address	ID/FEI	Business Operations
DR. REDDY'S LABORATORIES LIMITED		860037244	manufacture(68001-439, 68001-440) , analysis(68001-439, 68001-440)

Establishment
Name	Address	ID/FEI	Business Operations
Dr. Reddy's Laboratories Limited (FTO III)		918608162	analysis(68001-439, 68001-440) , manufacture(68001-439, 68001-440)