FEXOFENADINE HYDROCHLORIDE tablet, film coated

Active ingredient(in each tablet)

Fexofenadine HCl USP, 180 mg
Purpose

Antihistamine
Uses
temporarily relieves these symptoms due to hay fever or other upper resporatory allergies:
- runny nose
- sneezing
- itchy, watery 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 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

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

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 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 20°and 25°C (68°and 77°F)
- 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, steric acid, titanium dioxide, and yellow iron oxide,
Questions or comments?

call 1-855-274-4122
Principal Display Panel

Repackaged by:
Aidarex Pharmaceuticals, LLC
Corona, CA 92880

NDC: 53217-0363

*Compare to 24 Hour Allegra®
Allergy active ingrediant

Original Prescription Strength Non-Drowsy

Fexofenadine Hydrochloride Tablets USP, 180 mg/antihistamine

Allergy
Indoor & Outdoor Allergies

24 Hours Relief of:

Sneezing
Runny nose
Itchy, Watery Eyes
Itchy Nose or Throat

DO NOT USE IF FOIL SEAL IS TORN OR MISSING

90 Tablets 180 mg each

53217-0363_FEXOFENADINE-HCL_180MG

INGREDIENTS AND APPEARANCE

FEXOFENADINE HYDROCHLORIDE
fexofenadine hydrochloride tablet, film coated

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
FEXOFENADINE HYDROCHLORIDE (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V)	FEXOFENADINE HYDROCHLORIDE	180 mg

Ingredient Name	Strength
Inactive Ingredients
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 53217-363-90	90 in 1 BOTTLE; Type 0: Not a Combination Product	02/01/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA202039	02/01/2018

Labeler - Aidarex Pharmaceuticals LLC (801503249)

Name	Address	ID/FEI	Business Operations
Establishment
Aidarex Pharmaceuticals		801503249	REPACK(53217-363)

Fexofenadine hydrochloride by