Fexofenadine hydrochloride tablet, film coated

Active ingredient (in each tablet)


For 60 mg:

Fexofenadine HCl USP, 60 mg


For 180 mg:

Fexofenadine HCl USP, 180 mg

Purpose


Antihistamine

Uses


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

  • runny nose
  • sneezing
  • itchy, watery eyes
  • itching of the nose or throat

Warnings

Do not useif 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 aluminium or magnesium antacids
  • do not take with fruit juices (see Directions)

Stop use and ask 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

For 60 mg:

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

For 180 mg:

adults and children 12 years of age and over take one 180 mg tablet with water once a day;
do not take more than1 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 20and 25C (68and 77F)
  • protect from excessive moisture and light

Inactive ingredients



anhydrous lactose, colloidal silicon dioxide, corn starch,croscarmellose sodium, hypromellose, lactose monohydrate, polyethylene glycol 400, pregelatinized corn starch, red iron oxide, stearic acid, titanium dioxide, and yellow iron oxide

Questions or comments?


call toll free 1-866-850-2876



Ingredients and appearance - Product information

Fexofenadine hydrochloride tablet, film coated- Fexofenadine hydrochloride

Product information

Product Type Human OTC Drug Label Item Code (Source) NDC: 13107-066
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Fexofenadine hydrochloride ( UNII: 2S068B75ZU)( Fexofenadine - UNII: E6582LOH6V ) 60 mgin 1

Inactive Ingredients

Ingredient Name Code
Anhydrous lactose ( UNII: 3SY5LH9PMK)
Colloidal silicon dioxide ( UNII: ETJ7Z6XBU4)
Croscarmellose sodium ( UNII: M28OL1HH48)
Hypromelloses ( UNII: 3NXW29V3WO)
Lactose monohydrate ( UNII: EWQ57Q8I5X)
Starch, pregelatinized corn ( UNII: O8232NY3SJ)
Stearic acid ( UNII: 4ELV7Z65AP)
Ferric oxide red ( UNII: 1K09F3G675)
Ferric oxide yellow ( UNII: EX438O2MRT)
Polyethylene glycol 400 ( UNII: B697894SGQ)
Titanium dioxide ( UNII: 15FIX9V2JP)

Product Characteristics

Color ORANGE (Peach) Shape CAPSULE (Bevel Edge, Biconvex)
Size 12 mm Score 1
Imprint Code E;42

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA202039 USA

Fexofenadine hydrochloride tablet, film coated- Fexofenadine hydrochloride

Product information

Product Type Human OTC Drug Label Item Code (Source) NDC: 13107-067
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Fexofenadine hydrochloride ( UNII: 2S068B75ZU)( Fexofenadine - UNII: E6582LOH6V ) 180 mgin 1

Inactive Ingredients

Ingredient Name Code
Anhydrous lactose ( UNII: 3SY5LH9PMK)
Colloidal silicon dioxide ( UNII: ETJ7Z6XBU4)
Croscarmellose sodium ( UNII: M28OL1HH48)
Hypromelloses ( UNII: 3NXW29V3WO)
Lactose monohydrate ( UNII: EWQ57Q8I5X)
Starch, pregelatinized corn ( UNII: O8232NY3SJ)
Stearic acid ( UNII: 4ELV7Z65AP)
Ferric oxide red ( UNII: 1K09F3G675)
Ferric oxide yellow ( UNII: EX438O2MRT)
Polyethylene glycol 400 ( UNII: B697894SGQ)
Titanium dioxide ( UNII: 15FIX9V2JP)

Product Characteristics

Color ORANGE (Peach) Shape CAPSULE (Bevel Edge, Biconvex)
Size 17 mm Score 1
Imprint Code E;44

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA202039 USA

Labeler - Aurolife Pharma, LLC( 829084461)

Establishment

Name ID/FEI Business Operations
Aurolife Pharma, LLC 829084461 MANUFACTURE( 13107-066, 13107-067)

Principal display panel - 60 mg 500's count



NDC 13107-066-05


*Compare to12 Hour Allegra®
Allergy active ingredient


Fexofenadine Hydrochloride Tablets USP,60 mg/antihistamine

Allergy

Relief of:


Sneezing
R
unny nose
Itchy, watery eyes
Itchy nose or throat12 Hour

Indoor & Outdoor Allergies

DO NOT USE IF FOIL SEAL IS TORN OR MISSING

500 Tablets 60 mg each




Principal display panel - 180 mg 500's count

NDC 13107-067-05


*Compare to24 Hour Allegra®
Allergy active ingredient


Fexofenadine Hydrochloride Tablets USP, 180 mg/antihistamine

Allergy

Relief of:


Sneezing
R
unny nose
Itchy, watery eyes
Itchy nose or throat 24 Hour

Indoor & Outdoor Allergies

DO NOT USE IF FOIL SEAL IS TORN OR MISSING

500 Tablets 180 mg each