ALLEGRA ALLERGY- fexofenadine hydrochloride tablet, film coated

Allegra Allergy by

Drug Labeling and Warnings

Allegra Allergy by is a Otc medication manufactured, distributed, or labeled by Chattem, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Allegra Allergy

Allegra Allergy® - 12/24 HOUR

Drug Facts

Active ingredient

(in each tablet)
12 Hour Tablet: Fexofenadine HCl 60 mg

24 Hour Tablet: Fexofenadine HCl 180 mg

Purpose

Antihistamine

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

• runny nose
  
• sneezing
  
• itchy, water 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.

Allegra 12 Hour 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

Allegra 24 Hour 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 individual blister units are torn or opened or if inner foil seal on bottle is torn or missing
  
• store between 20° and 25°C (68° and 77°F)
  
• protect from excessive moisture

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide blends, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, titanium dioxide

Questions or comments?

call toll-free 1-800-633-1610 or www.allegra.com

PRINCIPAL DISPLAY PANEL

NDC: 41167-4131-4
Allegra
ALLERGY
60 mg/ antihistamine
12 HR
24 TABLETS

PRINCIPAL DISPLAY PANEL

NDC: 41167-4120-3
Allegra
ALLERGY
180 mg/ antihistamine
24 HR
30 TABLETS

PRINCIPAL DISPLAY PANEL

Allegra
ALLERGY
180 mg/ antihistamine
24 HR
40 TABLETS

INGREDIENTS AND APPEARANCE

ALLEGRA ALLERGY 
fexofenadine hydrochloride tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41167-4131
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)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	ORANGE (peach)	Score	no score
Shape	OVAL	Size	12mm
Flavor		Imprint Code	06;E
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41167-4131-2	1 in 1 CARTON	03/03/2011
1		12 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 41167-4131-4	2 in 1 CARTON	03/03/2011
2		12 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC: 41167-4131-6	3 in 1 CARTON	03/02/2019
3		12 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
NDA	NDA020872	03/03/2011

ALLEGRA ALLERGY 
fexofenadine hydrochloride tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41167-4120
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)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)
STARCH, CORN (UNII: O8232NY3SJ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	ORANGE (peach)	Score	no score
Shape	OVAL	Size	17mm
Flavor		Imprint Code	018;E
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41167-4120-1	1 in 1 CARTON	03/03/2011
1		2 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 41167-4120-0	1 in 1 CARTON	03/03/2011
2		5 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC: 41167-4120-2	3 in 1 CARTON	03/03/2011
3		5 in 1 BLISTER PACK; Type 0: Not a Combination Product
4	NDC: 41167-4120-3	1 in 1 CARTON	03/03/2011
4		30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
5	NDC: 41167-4120-4	1 in 1 CARTON	03/03/2011
5		45 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
6	NDC: 41167-4120-5	2 in 1 CARTON	03/03/2011
6		45 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
7	NDC: 41167-4120-6	1 in 1 CARTON	03/03/2011
7		70 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA020872	03/03/2011

ALLEGRA ALLERGY 
fexofenadine hydrochloride tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41167-4121
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)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)
STARCH, CORN (UNII: O8232NY3SJ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	ORANGE (peach)	Score	no score
Shape	OVAL	Size	17mm
Flavor		Imprint Code	018;E
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41167-4121-3	2 in 1 PACKAGE	03/03/2011	11/03/2018
1		1 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 41167-4121-2	2 in 1 POUCH	03/03/2011	02/18/2020
2		1 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC: 41167-4121-0	1 in 1 PACKAGE	03/03/2011	02/18/2020
3		1 in 1 BLISTER PACK; Type 0: Not a Combination Product
4	NDC: 41167-4121-1	1 in 1 CARTON	03/03/2011	08/01/2019
4		60 in 1 BOTTLE; Type 0: Not a Combination Product
5	NDC: 41167-4121-6	1 in 1 CARTON	03/03/2011	04/04/2017
5		37 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
6	NDC: 41167-4121-7	1 in 1 CARTON	03/03/2011	03/03/2017
6		54 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
7	NDC: 41167-4121-4	1 in 1 CARTON	03/03/2011
7		40 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
8	NDC: 41167-4121-5	2 in 1 CARTON	03/03/2011	02/01/2018
8		30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA020872	03/03/2011

Labeler - Chattem, Inc. (003336013)