CHILDRENS 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 overtake 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 agetake one 30 mg tablet with water every 12 hours; do not take more than 2 tablets in 24 hours
children under 6 years of agedo not use
adults 65 years of age and olderask a doctor
consumers with kidney diseaseask 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 overtake one 60 mg tablet with water every 12 hours; do not take more than 2 tablets in 24 hours
children under 12 years of agedo not use
adults 65 years of age and olderask a doctor
consumers with kidney diseaseask 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® - 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

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

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 41167-4131-2
Allegra® Allergy
fexofenadine HCI tablet 60 mg/antihistamine
Indoor and Outdoor Allergies
12 Tablets 60 mg each
12 HOUR

PRINCIPAL DISPLAY PANEL
NDC 41167-4131-2
Allegra® Allergy
fexofenadine HCI tablet 60 mg/antihistamine
Indoor and Outdoor Allergies
12 Tablets 60 mg each
12 HOUR

PRINCIPAL DISPLAY PANEL

NDC 41167-4120-1
Allegra® Allergy
fexofenadine HCI tablet 180 mg/antihistamine
Indoor and Outdoor Allergies
2 Tablets 180 mg each
24 HOUR

PRINCIPAL DISPLAY PANEL
NDC 41167-4120-1
Allegra® Allergy
fexofenadine HCI tablet 180 mg/antihistamine
Indoor and Outdoor Allergies
2 Tablets 180 mg each
24 HOUR

PRINCIPAL DISPLAY PANEL

NDC 41167-4120-1
Blister

PRINCIPAL DISPLAY PANEL
NDC 41167-4120-1
Blister

PRINCIPAL DISPLAY PANEL

NDC 41167-4120-0
Allegra® Allergy
fexofenadine HCI tablet 180 mg/antihistamine
Indoor and Outdoor Allergies
5 Tablets 180 mg each
24 HOUR

PRINCIPAL DISPLAY PANEL
NDC 41167-4120-0
Allegra® Allergy
fexofenadine HCI tablet 180 mg/antihistamine
Indoor and Outdoor Allergies
5 Tablets 180 mg each
24 HOUR

PRINCIPAL DISPLAY PANEL

NDC 41167-4120-0
Blister

PRINCIPAL DISPLAY PANEL
NDC 41167-4120-0
Blister

PRINCIPAL DISPLAY PANEL

NDC 41167-4120-3
Allegra® Allergy
fexofenadine HCI tablet 180 mg/antihistamine
Indoor and Outdoor Allergies
30 Tablets 180 mg each
24 HOUR

PRINCIPAL DISPLAY PANEL
NDC 41167-4120-3
Allegra® Allergy
fexofenadine HCI tablet 180 mg/antihistamine
Indoor and Outdoor Allergies
30 Tablets 180 mg each
24 HOUR
PRINCIPAL DISPLAY PANEL

NDC 41167-4125-8
Allegra® Allergy
BONUS ALLERGY PACK!
5 Tablets FREE
Contains 1 Allegra® Allergy 24 hr 30 ct and 1 Allegra® Allergy 24 hr 5 ct

PRINCIPAL DISPLAY PANEL
NDC 41167-4125-8
Allegra® Allergy
BONUS ALLERGY PACK!
5 Tablets FREE
Contains 1 Allegra® Allergy 24 hr 30 ct and 1 Allegra® Allergy 24 hr 5 ct

PRINCIPAL DISPLAY PANEL

NDC 41167-4120-4
Allegra® Allergy
fexofenadine HCI tablet 180 mg/antihistamine
Indoor and Outdoor Allergies
45 Tablets 180 mg each
24 HOUR

PRINCIPAL DISPLAY PANEL
NDC 41167-4120-4
Allegra® Allergy
fexofenadine HCI tablet 180 mg/antihistamine
Indoor and Outdoor Allergies
45 Tablets 180 mg each
24 HOUR

PRINCIPAL DISPLAY PANEL

NDC 41167-4120-4
Bottle Label

PRINCIPAL DISPLAY PANEL
NDC 41167-4120-4
Bottle Label

PRINCIPAL DISPLAY PANEL

NDC 41167-4120-6
Allegra® Allergy
fexofenadine HCI tablet 180 mg/antihistamine
Indoor and Outdoor Allergies
70 Tablets 180 mg each
24 HOUR

PRINCIPAL DISPLAY PANEL
NDC 41167-4120-6
Allegra® Allergy
fexofenadine HCI tablet 180 mg/antihistamine
Indoor and Outdoor Allergies
70 Tablets 180 mg each
24 HOUR

PRINCIPAL DISPLAY PANEL

NDC 41167-4120-6
Bottle Label

PRINCIPAL DISPLAY PANEL
NDC 41167-4120-6
Bottle Label

PRINCIPAL DISPLAY PANEL

NDC 41167-4120-5
Allegra® Allergy
fexofenadine HCI tablet 180 mg/antihistamine
Indoor and Outdoor Allergies
90 Tablets 180 mg each
Contains Two 45-Count Bottles!
24 HOUR

PRINCIPAL DISPLAY PANEL
NDC 41167-4120-5
Allegra® Allergy
fexofenadine HCI tablet 180 mg/antihistamine
Indoor and Outdoor Allergies
90 Tablets 180 mg each
Contains Two 45-Count Bottles!
24 HOUR

CHILDRENS ALLEGRA ALLERGY 
fexofenadine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-4222
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE) FEXOFENADINE HYDROCHLORIDE30 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
CROSCARMELLOSE SODIUM 
HYPROMELLOSES 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOLS 
POVIDONE 
STARCH, CORN 
TITANIUM DIOXIDE 
Product Characteristics
ColorORANGE (peach) Scoreno score
ShapeOVALSize17mm
FlavorImprint Code E;018
Contains    
Packaging
#Item CodePackage Description
1NDC:41167-4222-21 in 1 CARTON
16 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02087203/03/2011
ALLEGRA ALLERGY 
fexofenadine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-4131
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE) FEXOFENADINE HYDROCHLORIDE60 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
CROSCARMELLOSE SODIUM 
HYPROMELLOSES 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOLS 
POVIDONE 
TITANIUM DIOXIDE 
STARCH, CORN 
Product Characteristics
ColorORANGE (peach) Scoreno score
ShapeOVALSize12mm
FlavorImprint Code 06;E
Contains    
Packaging
#Item CodePackage Description
1NDC:41167-4131-22 in 1 CARTON
16 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02087203/03/2011
ALLEGRA ALLERGY 
fexofenadine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-4120
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE) FEXOFENADINE HYDROCHLORIDE180 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
CROSCARMELLOSE SODIUM 
HYPROMELLOSES 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOLS 
POVIDONE 
STARCH, CORN 
TITANIUM DIOXIDE 
Product Characteristics
ColorORANGE (peach) Scoreno score
ShapeOVALSize17mm
FlavorImprint Code 018;E
Contains    
Packaging
#Item CodePackage Description
1NDC:41167-4120-01 in 1 CARTON
15 in 1 BLISTER PACK
2NDC:41167-4120-23 in 1 CARTON
25 in 1 BLISTER PACK
3NDC:41167-4120-11 in 1 CARTON
32 in 1 BLISTER PACK
4NDC:41167-4120-61 in 1 CARTON
470 in 1 BOTTLE, PLASTIC
5NDC:41167-4120-31 in 1 CARTON
530 in 1 BOTTLE, PLASTIC
6NDC:41167-4120-41 in 1 CARTON
645 in 1 BOTTLE, PLASTIC
7NDC:41167-4120-52 in 1 CARTON
745 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02087203/03/2011
Labeler - Chattem, Inc. (003336013)
Establishment
NameAddressID/FEIBusiness Operations
Chattem Plant 1003336013ANALYSIS, LABEL, MANUFACTURE, PACK, RECOVERY, RELABEL, REPACK
Establishment
NameAddressID/FEIBusiness Operations
Chattem Plant 3832973031LABEL, MANUFACTURE, PACK, RECOVERY, RELABEL, REPACK
Establishment
NameAddressID/FEIBusiness Operations
Sanofi-Aventis U.S. LLC783243835ANALYSIS, LABEL, MANUFACTURE, PACK
Establishment
NameAddressID/FEIBusiness Operations
Sanofi-Aventis U.S. LLC011330557LABEL, PACK

Revised: 04/2012
 
Chattem, Inc.