FEXOFENADINE HYDROCHLORIDE- fexofenadine hydrochloride tablet, film coated 
Pharmacy Value Alliance, LLC

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Indoor and Outdoor Allergies
Original Prescription Strength
NON-DROWSY

ALLERGY RELIEF
Fexofenadine Hydrochloride Tablets, USP

180mg/Antihistamine

Active ingredient

(in each film-coated tablet)

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 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.

Directions

adults and children 12 years of age and over

children under 12 years of age

adults 65 years of age and older

consumers with kidney disease

Other Information

■ store between 20° and 25°C (68° and 77°F)

■ protect from excessive moisture

■ each tablet contains: sodium 8.2 mg

■ this product meets the requirements of USP Dissolution Test 2

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 and yellow iron oxide.

Questions?

call 1-877-770-3183 Mon-Fri 9:00 AM to 4:30 PM EST.

15 count30 count45 count

FEXOFENADINE HYDROCHLORIDE 
fexofenadine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-769
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
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
Product Characteristics
ColorpinkScoreno score
ShapeOVAL (Capsule Shaped Tablets) Size17mm
FlavorImprint Code SG;202
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68016-769-0715 in 1 BLISTER PACK; Type 0: Not a Combination Product06/01/2019
2NDC:68016-769-0330 in 1 BOTTLE; Type 0: Not a Combination Product06/01/2019
3NDC:68016-769-4545 in 1 BOTTLE; Type 0: Not a Combination Product06/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20450706/01/2019
Labeler - Pharmacy Value Alliance, LLC (101668460)

Revised: 1/2021
Document Id: ba16adf1-6f4e-b473-e053-2a95a90a7219
Set id: 8385745b-ca1d-1acb-e053-2a91aa0a7aab
Version: 2
Effective Time: 20210129
 
Pharmacy Value Alliance, LLC