Allegra Allergy: Package Insert and Label Information

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

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 HR24 TABLETS

PRINCIPAL DISPLAY PANEL
NDC 41167-4131-4
Allegra
ALLERGY
60 mg/ antihistamine
12 HR
24 TABLETS
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 41167-4120-3
Allegra
ALLERGY
180 mg/ antihistamine
24 HR30 TABLETS

PRINCIPAL DISPLAY PANEL
NDC 41167-4120-3
Allegra
ALLERGY
180 mg/ antihistamine
24 HR
30 TABLETS
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

Allegra
ALLERGY
180 mg/ antihistamine
24 HR40 TABLETS

PRINCIPAL DISPLAY PANEL
Allegra
ALLERGY
180 mg/ antihistamine
24 HR
40 TABLETS
(click image for full-size original)


PRINCIPAL DISPLAY PANEL

Allegra
ALLERGY
180 mg/ antihistamine
24 HR90 TABLETS

Allegra
ALLERGY
180 mg/ antihistamine
24 HR
90 TABLETS
(click image for full-size original)

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
CROSCARMELLOSE SODIUM
HYPROMELLOSES
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL, UNSPECIFIED
POVIDONE
TITANIUM DIOXIDE
STARCH, CORN
BROWN IRON OXIDE
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 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 12 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (41167-4131-2)
2 NDC:41167-4131-4 2 BLISTER PACK in 1 CARTON contains a BLISTER PACK
2 12 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (41167-4131-4)
3 NDC:41167-4131-6 3 BLISTER PACK in 1 CARTON contains a BLISTER PACK
3 12 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (41167-4131-6)
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
CROSCARMELLOSE SODIUM
HYPROMELLOSES
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL, UNSPECIFIED
POVIDONE
STARCH, CORN
TITANIUM DIOXIDE
BROWN IRON OXIDE
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:41167-4120-1 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 2 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (41167-4120-1)
2 NDC:41167-4120-0 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK
2 5 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (41167-4120-0)
3 NDC:41167-4120-2 3 BLISTER PACK in 1 CARTON contains a BLISTER PACK
3 5 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (41167-4120-2)
4 NDC:41167-4120-3 1 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC
4 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC This package is contained within the CARTON (41167-4120-3)
5 NDC:41167-4120-4 1 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC
5 45 TABLET, FILM COATED in 1 BOTTLE, PLASTIC This package is contained within the CARTON (41167-4120-4)
6 NDC:41167-4120-5 2 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC
6 45 TABLET, FILM COATED in 1 BOTTLE, PLASTIC This package is contained within the CARTON (41167-4120-5)
7 NDC:41167-4120-6 1 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC
7 70 TABLET, FILM COATED in 1 BOTTLE, PLASTIC This package is contained within the CARTON (41167-4120-6)
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 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
CROSCARMELLOSE SODIUM
HYPROMELLOSES
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL, UNSPECIFIED
POVIDONE
STARCH, CORN
TITANIUM DIOXIDE
BROWN IRON OXIDE
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:41167-4121-3 2 BLISTER PACK in 1 PACKAGE contains a BLISTER PACK
1 1 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the PACKAGE (41167-4121-3)
2 NDC:41167-4121-2 2 BLISTER PACK in 1 POUCH contains a BLISTER PACK
2 1 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the POUCH (41167-4121-2)
3 NDC:41167-4121-0 1 BLISTER PACK in 1 PACKAGE contains a BLISTER PACK
3 1 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the PACKAGE (41167-4121-0)
4 NDC:41167-4121-1 1 BOTTLE in 1 CARTON contains a BOTTLE
4 60 TABLET, FILM COATED in 1 BOTTLE This package is contained within the CARTON (41167-4121-1)
5 NDC:41167-4121-6 1 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC
5 37 TABLET, FILM COATED in 1 BOTTLE, PLASTIC This package is contained within the CARTON (41167-4121-6)
6 NDC:41167-4121-7 1 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC
6 54 TABLET, FILM COATED in 1 BOTTLE, PLASTIC This package is contained within the CARTON (41167-4121-7)
7 NDC:41167-4121-4 1 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC
7 40 TABLET, FILM COATED in 1 BOTTLE, PLASTIC This package is contained within the CARTON (41167-4121-4)
8 NDC:41167-4121-5 2 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC
8 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC This package is contained within the CARTON (41167-4121-5)
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:41167-4124
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
CROSCARMELLOSE SODIUM
HYPROMELLOSES
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL, UNSPECIFIED
POVIDONE
STARCH, CORN
TITANIUM DIOXIDE
BROWN IRON OXIDE
Product Characteristics
Color orange Score no score
Shape OVAL Size 17mm
Flavor Imprint Code 018;E
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:41167-4124-7 1 BOTTLE in 1 CARTON contains a BOTTLE
1 84 TABLET, FILM COATED in 1 BOTTLE This package is contained within the CARTON (41167-4124-7)
2 NDC:41167-4124-0 1 BOTTLE in 1 CARTON contains a BOTTLE
2 90 TABLET, FILM COATED in 1 BOTTLE This package is contained within the CARTON (41167-4124-0)
3 NDC:41167-4124-3 2 BOTTLE in 1 PACKAGE contains a BOTTLE (41167-4124-5)
3 NDC:41167-4124-5 55 TABLET, FILM COATED in 1 BOTTLE This package is contained within the PACKAGE (41167-4124-3)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020872 10/01/2020
Labeler — Chattem, Inc. (003336013)

Revised: 04/2021 Chattem, Inc.

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