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Fexofenadine HCl by QUALITY CHOICE (Chain Drug Marketing Association)

Medically reviewed on Apr 23, 2018

Dosage form: tablet
Ingredients: FEXOFENADINE HYDROCHLORIDE 180mg
Labeler: QUALITY CHOICE (Chain Drug Marketing Association)
NDC Code: 63868-141

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:

  • runny nose
  • itchy, watery eyes
  • sneezing
  • 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 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
  • each tablet contains: sodium 8 mg
  • store between 20-25ºC (68-77ºF)
  • protect from excessive moisture
  • this product meets the requirements of USP Dissolution Test 2

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

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 AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE) FEXOFENADINE HYDROCHLORIDE180 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
CROSCARMELLOSE SODIUM 
HYPROMELLOSES 
FERRIC OXIDE RED 
FERRIC OXIDE YELLOW 
LACTOSE MONOHYDRATE 
POLYETHYLENE GLYCOLS 
TITANIUM DIOXIDE 
ANHYDROUS LACTOSE 
STARCH, CORN 
STEARIC ACID 
Product Characteristics
ColorWHITEScoreno score
ShapeCAPSULESize17mm
FlavorImprint CodeSG;202
Contains    
Packaging
#Item CodePackage Description
1NDC:63868-141-301 BOTTLE, PLASTIC in 1 BOX
130 TABLET in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07911203/31/2016
Labeler - QUALITY CHOICE (Chain Drug Marketing Association) (011920774)

 
QUALITY CHOICE (Chain Drug Marketing Association)

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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