FEXOFENADINE HCL- fexofenadine hcl tablet 
QUALITY CHOICE (Chain Drug Marketing Association)

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DRUG FACTS

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:

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 overtake one 180 mg tablet with water once a day; do not take more than 1 tablet in 24 hours
children under 12 years of agedo not use
adults 65 years of age and olderask a doctor
consumers with kidney diseaseask a doctor

Other information

Inactive ingredients

anhydrous lactose,colloidal silicon dioxide, corn starch, croscarmellose sodium, lactose monohydrate, pregelatinized starch (maize), stearic acid, opadry pink 03B84893 containing hypromellose, polyethylene glycol, red iron oxide, titanium dioxide, and yellow iron oxide

Questions or comments?

call 1-248-449-9300 Monday- Friday 9AM- 5PM EST

Principal Display Panel

†Compare to the active ingredient in Allegra® Allergy 24 hour*

ORIGINAL PRESCRIPTION STRENGTH

Fexofenadine hydrochloride

tablets USP, 180 mg / Antihistamine

Indoor and outdoor allergies

Non-Drowsy

24 Hour Relief of:

sneezing

runny nose

itchy, watery eyes

itchy nose or throat

Tablets

†This product is not manufactured or distributed by Chattem Inc., distributor of Allegra® Allergy 24 hour

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

Distributed by C.D.M.A., Inc.©

43157 W. Nine Mile

Novi, MI 48376-0995

www.qualitychoice.com

Product Label

Fexofenadine HCI USP 180 mg

Quality Choice Fexofenadine Hydrochloride Tablets USP, 180 mg

FEXOFENADINE HCL 
fexofenadine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-141
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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
STARCH, CORN (UNII: O8232NY3SJ)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorwhiteScoreno score
ShapeCAPSULESize17mm
FlavorImprint Code SG;202
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63868-141-301 in 1 BOX03/31/201603/31/2025
130 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07911203/31/201603/31/2025
Labeler - QUALITY CHOICE (Chain Drug Marketing Association) (011920774)

Revised: 5/2023
Document Id: fb214245-0f46-4fab-a24e-5261d6b07252
Set id: d1b375dd-bbdb-41fe-a496-89b88dddb26a
Version: 3
Effective Time: 20230502
 
QUALITY CHOICE (Chain Drug Marketing Association)