CHILDRENS ALLEGRA ALLERGY - fexofenadine hydrochloride tablet, film coated
ALLEGRA ALLERGY - fexofenadine hydrochloride tablet, film coated
Chattem, Inc.

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Children's Allegra Allergy® - 12 HOUR

Drug Facts

Active ingredient

(in each tablet)

Fexofenadine HCI 30 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.

Directions

adults and children 12 years of age and over	take two 30 mg tablets with water every 12 hours; do not take more than 4 tablets in 24 hours
children 6 to under 12 years of age	take one 30 mg tablet with water every 12 hours; do not take more than 2 tablets in 24 hours
children under 6 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
store between 20º and 25ºC (68º and 77ºF)
protect from excessive moisture

Inactive ingredients

colloidal silicone 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

Allegra Allergy® - 12 HOUR

Drug Facts

Active ingredient

(in each tablet)

Fexofenadine HCI 60 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.

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

safety sealed: do not use if carton is opened or if individual blister units are torn or opened
store between 20º and 25ºC (68º and 77ºF)
protect from excessive moisture

Inactive ingredients

Questions or comments?

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

Allegra Allergy® - 24 HOUR

Drug Facts

Active ingredient

(in each tablet)

Fexofenadine HCI 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.

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 20º and 25ºC (68º and 77ºF)
protect from excessive moisture

Inactive ingredients

Questions or comments?

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

The makers of Allegra® do not make store brand products. The trade dress of this Allegra® package is subject to trademark protection.
Dist. By: Chattem, Inc. (part of the sanofi-aventis Group), Chattanooga, TN 37409-0219 ©2010

PRINCIPAL DISPLAY PANEL

NDC 41167-4222-2
ORIGINAL PRESCRIPTION STRENGTH NON-DROWSY
Children’s Allegra®
Allergy
fexofenadine HCl tablet
30 mg/antihistamine
Indoor and Outdoor Allergies
6 Tablets 30 mg each 12 HOUR

PRINCIPAL DISPLAY PANEL
NDC 41167-4222-2
ORIGINAL PRESCRIPTION STRENGTH NON-DROWSY
Children’s Allegra®
Allergy
fexofenadine HCl tablet
30 mg/antihistamine
Indoor and Outdoor Allergies
6 Tablets 30 mg each 12 HOUR

PRINCIPAL DISPLAY PANEL

NDC 41167-4131-2
ORIGINAL PRESCRIPTION STRENGTH NON-DROWSY
Allegra® Allergy
fexofenadine HCl tablet

60 mg/antihistamine
Indoor and Outdoor Allergies
12 Tablets 60 mg each 12 HOUR

PRINCIPAL DISPLAY PANEL
NDC 41167-4131-2
ORIGINAL PRESCRIPTION STRENGTH NON-DROWSY
Allegra® Allergy
fexofenadine HCl tablet
60 mg/antihistamine
Indoor and Outdoor Allergies
12 Tablets 60 mg each 12 HOUR

PRINCIPAL DISPLAY PANEL

NDC 41167-4120-3
ORIGINAL PRESCRIPTION STRENGTH NON-DROWSY
Allegra® Allergy
fexofenadine HCl tablet
180 mg/antihistamine
Indoor and Outdoor Allergies
30 Tablets 180 mg each 24 HOUR
NDC 41167-4120-3
ORIGINAL PRESCRIPTION STRENGTH NON-DROWSY
Allegra® Allergy
fexofenadine HCl tablet
180 mg/antihistamine
Indoor and Outdoor Allergies
30 Tablets 180 mg each 24 HOUR

CHILDRENS ALLEGRA ALLERGY
fexofenadine hydrochloride tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:41167-4222
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE)	FEXOFENADINE HYDROCHLORIDE	30 mg

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE, COLLOIDAL
CROSCARMELLOSE SODIUM
HYPROMELLOSES
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL
POVIDONE
STARCH, PREGELATINIZED CORN
TITANIUM DIOXIDE

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

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:41167-4222-2	1 BLISTER PACK (1 BLISTER PACK) in 1 CARTON	contains a BLISTER PACK
1		6 TABLET, FILM COATED (6 TABLET) in 1 BLISTER PACK	This package is contained within the CARTON (41167-4222-2)

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:41167-4131
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE)	FEXOFENADINE HYDROCHLORIDE	60 mg

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE, COLLOIDAL
CROSCARMELLOSE SODIUM
HYPROMELLOSES
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL
POVIDONE
TITANIUM DIOXIDE
STARCH, PREGELATINIZED CORN

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

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:41167-4131-2	2 BLISTER PACK (2 BLISTER PACK) in 1 CARTON	contains a BLISTER PACK
1		6 TABLET, FILM COATED (6 TABLET) in 1 BLISTER PACK	This package is contained within the CARTON (41167-4131-2)

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	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE)	FEXOFENADINE HYDROCHLORIDE	180 mg

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE, COLLOIDAL
CROSCARMELLOSE SODIUM
HYPROMELLOSES
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL
POVIDONE
STARCH, PREGELATINIZED CORN
TITANIUM DIOXIDE

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

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:41167-4120-0	1 BLISTER PACK (1 BLISTER PACK) in 1 CARTON	contains a BLISTER PACK
1		5 TABLET, FILM COATED (5 TABLET) in 1 BLISTER PACK	This package is contained within the CARTON (41167-4120-0)
2	NDC:41167-4120-2	3 BLISTER PACK (3 BLISTER PACK) in 1 CARTON	contains a BLISTER PACK
2		5 TABLET, FILM COATED (5 TABLET) in 1 BLISTER PACK	This package is contained within the CARTON (41167-4120-2)
3	NDC:41167-4120-1	1 BLISTER PACK (1 BLISTER PACK) in 1 CARTON	contains a BLISTER PACK
3		2 TABLET, FILM COATED (2 TABLET) in 1 BLISTER PACK	This package is contained within the CARTON (41167-4120-1)
4	NDC:41167-4120-6	1 BOTTLE, PLASTIC (1 BOTTLE) in 1 CARTON	contains a BOTTLE, PLASTIC
4		70 TABLET, FILM COATED (70 TABLET) in 1 BOTTLE, PLASTIC	This package is contained within the CARTON (41167-4120-6)
5	NDC:41167-4120-3	1 BOTTLE, PLASTIC (1 BOTTLE) in 1 CARTON	contains a BOTTLE, PLASTIC
5		30 TABLET, FILM COATED (30 TABLET) in 1 BOTTLE, PLASTIC	This package is contained within the CARTON (41167-4120-3)
6	NDC:41167-4120-4	1 BOTTLE, PLASTIC (1 BOTTLE) in 1 CARTON	contains a BOTTLE, PLASTIC
6		45 TABLET, FILM COATED (45 TABLET) in 1 BOTTLE, PLASTIC	This package is contained within the CARTON (41167-4120-4)
7	NDC:41167-4120-5	2 BOTTLE, PLASTIC (2 BOTTLE) in 1 CARTON	contains a BOTTLE, PLASTIC
7		45 TABLET, FILM COATED (45 TABLET) in 1 BOTTLE, PLASTIC	This package is contained within the CARTON (41167-4120-5)

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

Labeler - Chattem, Inc. (003336013)

Establishment
Name	Address	ID/FEI	Operations
Chattem Plant 1		003336013	ANALYSIS, LABEL, MANUFACTURE, PACK, RECOVERY, RELABEL, REPACK

Establishment
Name	Address	ID/FEI	Operations
Chattem Plant 3		832973031	LABEL, MANUFACTURE, PACK, RECOVERY, RELABEL, REPACK

Establishment
Name	Address	ID/FEI	Operations
Sanofi-Aventis U.S. LLC		783243835	ANALYSIS, LABEL, MANUFACTURE, PACK

Establishment
Name	Address	ID/FEI	Operations
Sanofi-Aventis U.S. LLC		011330557	LABEL, PACK

Revised: 06/2011 Chattem, Inc.