ALLERGY RELIEF- fexofenadine hydrochloride tablet 
AAA Pharmaceutical, Inc.

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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:

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

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 TypeHUMAN OTC DRUGItem Code (Source)NDC:57344-192
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
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
ColorpinkScoreno score
ShapeOVAL (Modified oval shape) Size17mm
FlavorImprint Code SG;202
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57344-192-021 in 1 CARTON10/01/201810/31/2022
15 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:57344-192-041 in 1 CARTON06/01/201805/31/2021
230 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3NDC:57344-192-061 in 1 CARTON06/01/201802/28/2023
345 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20450706/01/201802/28/2023
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.