ALLERGY RELIEF- fexofenadine hydrochloride tablet 
Chain Drug Marketing Association, Inc.

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1191A-QCH-2023-0522

Drug Facts

Active ingredient (in each tablet)

Fexofenadine HCl 60 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 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

Other information

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, lactose monohydrate, macrogol, magnesium stearate, microcrystalline cellulose, pregelatinized starch, titanium dioxide

PRINCIPAL DISPLAY PANEL

QUALITY CHOICE®

NDC 83324-009-12

*Compare to the Active Ingredient in ALLEGRA® Allergy 12 Hour

Non-Drowsy

Allergy Relief

Fexofenadine Hydrochloride Tablets, 60 mg | Antihistamine

Indoor / Outdoor Allergies

Relief of:

Sneezing | Runny Nose

Itchy, Watery Eyes

Itchy Nose or Throat

12 Hour

actual size

12 TABLETS

image description

ALLERGY RELIEF 
fexofenadine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83324-009
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FEXOFENADINE HYDROCHLORIDE (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V) FEXOFENADINE HYDROCHLORIDE60 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
HYPROMELLOSE 2910 (15 MPA.S) (UNII: 36SFW2JZ0W)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STARCH, CORN (UNII: O8232NY3SJ)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
Colororange ((PEACH)) Scoreno score
ShapeOVALSize12mm
FlavorImprint Code G5
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83324-009-121 in 1 CARTON05/22/2023
112 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:83324-009-242 in 1 CARTON05/22/2023
212 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21107505/22/2023
Labeler - Chain Drug Marketing Association, Inc. (011920774)

Revised: 5/2023
Document Id: fc49fe88-56a3-6dcf-e053-6294a90adb84
Set id: fabb8c0d-b4da-ab73-e053-6394a90ab8b5
Version: 2
Effective Time: 20230522
 
Chain Drug Marketing Association, Inc.