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

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Allegra Allergy

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:

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 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

Allegra 24 Hour Directions

 adults and children 12 years of age and overtake one 180 mg tablet with water once a day; do not take
more than 1 tablet 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

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 41167-4131-4
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

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

Allegra
ALLERGY
180 mg/ antihistamine
24 HR
40 TABLETS


PRINCIPAL DISPLAY PANEL

Allegra
ALLERGY
180 mg/ antihistamine
24 HR
90 TABLETS

Allegra
ALLERGY
180 mg/ antihistamine
24 HR
90 TABLETS

ALLEGRA ALLERGY 
fexofenadine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-4131
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FEXOFENADINE HYDROCHLORIDE (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V) FEXOFENADINE HYDROCHLORIDE60 mg
Inactive Ingredients
Ingredient NameStrength
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)  
BROWN IRON OXIDE (UNII: 1N032N7MFO)  
Product Characteristics
Colororange (peach) Scoreno score
ShapeOVALSize12mm
FlavorImprint Code 06;E
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41167-4131-21 in 1 CARTON03/03/2011
112 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:41167-4131-42 in 1 CARTON03/03/2011
212 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:41167-4131-63 in 1 CARTON03/02/2019
312 in 1 BLISTER PACK; Type 0: Not a Combination Product
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 AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FEXOFENADINE HYDROCHLORIDE (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V) FEXOFENADINE HYDROCHLORIDE180 mg
Inactive Ingredients
Ingredient NameStrength
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)  
BROWN IRON OXIDE (UNII: 1N032N7MFO)  
Product Characteristics
Colororange (peach) Scoreno score
ShapeOVALSize17mm
FlavorImprint Code 018;E
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41167-4120-11 in 1 CARTON03/03/2011
12 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:41167-4120-01 in 1 CARTON03/03/2011
25 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:41167-4120-23 in 1 CARTON03/03/2011
35 in 1 BLISTER PACK; Type 0: Not a Combination Product
4NDC:41167-4120-31 in 1 CARTON03/03/2011
430 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
5NDC:41167-4120-41 in 1 CARTON03/03/2011
545 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
6NDC:41167-4120-52 in 1 CARTON03/03/2011
645 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
7NDC:41167-4120-61 in 1 CARTON03/03/2011
770 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
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:41167-4121
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FEXOFENADINE HYDROCHLORIDE (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V) FEXOFENADINE HYDROCHLORIDE180 mg
Inactive Ingredients
Ingredient NameStrength
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)  
BROWN IRON OXIDE (UNII: 1N032N7MFO)  
Product Characteristics
Colororange (peach) Scoreno score
ShapeOVALSize17mm
FlavorImprint Code 018;E
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41167-4121-22 in 1 POUCH03/03/201102/18/2020
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:41167-4121-32 in 1 PACKAGE03/03/201111/03/2018
21 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:41167-4121-61 in 1 CARTON03/03/201104/04/2017
337 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
4NDC:41167-4121-71 in 1 CARTON03/03/201103/03/2017
454 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
5NDC:41167-4121-41 in 1 CARTON03/03/2011
540 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
6NDC:41167-4121-52 in 1 CARTON03/03/201102/01/2018
630 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
7NDC:41167-4121-01 in 1 PACKAGE03/03/201102/18/2020
71 in 1 BLISTER PACK; Type 0: Not a Combination Product
8NDC:41167-4121-11 in 1 CARTON06/01/2021
860 in 1 BOTTLE; Type 0: Not a Combination Product
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:41167-4124
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FEXOFENADINE HYDROCHLORIDE (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V) FEXOFENADINE HYDROCHLORIDE180 mg
Inactive Ingredients
Ingredient NameStrength
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)  
BROWN IRON OXIDE (UNII: 1N032N7MFO)  
Product Characteristics
ColororangeScoreno score
ShapeOVALSize17mm
FlavorImprint Code 018;E
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41167-4124-71 in 1 CARTON02/01/2021
184 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:41167-4124-01 in 1 CARTON12/01/2020
290 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:41167-4124-32 in 1 PACKAGE10/01/2020
3NDC:41167-4124-555 in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:41167-4124-81 in 1 CARTON05/01/2022
4100 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02087210/01/2020
Labeler - Chattem, Inc. (003336013)

Revised: 5/2022
Document Id: 9800af50-0358-4ad3-8980-8e986df31e81
Set id: 81c1dcbb-28b3-4ad5-9f3d-9ccc16ddd173
Version: 51
Effective Time: 20220504
 
Chattem, Inc.