RES - 1192A - 2019-0911

Drug Facts

Active ingredient (in each 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, 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 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 (1-800-222-1222).

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

each tablet contains: sodium 8.2 mg
store between 20-25°C (68-77°F)
protect from excessive moisture
this product meets the requirements of USP Dissolution Test 2
retain carton for complete product information and warnings

Inactive ingredients

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

Questions or Comments?

1-844-705-4384

PRINCIPAL DISPLAY PANEL

RESTORE U

NDC 57344-192-02

COMPARE TO THE ACTIVE INGREDIENT IN ALLEGRA® ALLERGY 24 HOUR

NON-DROWSY

Allergy Relief

Fexofenadine Hydrochloride Tablets, 180 mg / Antihistamine

Indoor and Outdoor Allergies – Original Prescription Strength

Relieves: Sneezing, Runny Nose, Itchy, Watery Eyes, Itchy Nose or Throat

24 HR

Actual Size

5 TABLETS

image description

ALLERGY RELIEF
fexofenadine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:57344-192
Route of Administration	ORAL

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)
STEARIC ACID (UNII: 4ELV7Z65AP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
STARCH, CORN (UNII: O8232NY3SJ)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)

Product Characteristics
Color	pink	Score	no score
Shape	OVAL (Modified oval shape)	Size	17mm
Flavor		Imprint Code	SG;202
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:57344-192-02	1 in 1 CARTON	10/01/2018	10/31/2022
1		5 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC:57344-192-04	1 in 1 CARTON	06/01/2018	05/31/2021
2		30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3	NDC:57344-192-06	1 in 1 CARTON	06/01/2018	02/28/2023
3		45 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA204507	06/01/2018	02/28/2023

Labeler - AAA Pharmaceutical, Inc. (181192162)

Revised: 11/2021

Document Id: d010efeb-5f98-3620-e053-2995a90ad8ff

Set id: bc37ef93-a3f2-4ed6-b9a9-7986286b92c9

Version: 3

Effective Time: 20211105

AAA Pharmaceutical, Inc.