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Fexofenadine hydrochloride by Physicians Total Care, Inc.

Dosage form: tablet
Ingredients: Fexofenadine Hydrochloride 180mg
Labeler: Physicians Total Care, Inc.
NDC Code: 54868-6289

Fexofenadine HCl Tablets USP

Active ingredient(s)

Fexofenadine HCl USP, 180 mg

Purpose

Antihistamine

Use(s)

temporarily relieves these symptoms due to hay fever or otherupper respiratory allergies:

  • runny nose
  • itchy, watery eys
  • sneezing
  • itching of the nose or Throad



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 doctorshould 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 doctor if

Allergy

an allergic reaction to this product occurs. Seek medical help right away.

Pregnancy/Breastfeeding

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         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 agedo not use
Adults 65 years of age  and olderask a doctor
consumers with kidney diseaseask a doctor

Other information

safety sealed: do not use if carton is opened or if individual blister units are torn or opened.

Storage

store between 20° - 25°C (68° - 77°F)

protect from excessive moisture

Inactive ingredients

colloidal silicon dioxide, corn starch, croscarmellose sodium, magnesium stearate, mannitol, and powdered cellulose, opadry pink 03B54504 containing FD&C Red no. 40, hypromellose, iron oxide black, polyethylene glycol and titanium dioxide.

Questions

call toll-free 1-888-375-3784

Manufactured by:

Dr. Reddy’s Laboratories Louisiana LLC,

8800 Line Ave Shreveport, LA, 71106. 

OR

Manufactured by:

Dr. Reddy’s Laboratories Limited

Bachepalli - 502 325 INDIA

Additional barcode labeling by:
Physicians Total Care, Inc.
Tulsa, OK      74146

Principal Display Panel

Fexofenadine HCl USP, 180 mg

NDC 54868-6289-0

FEXOFENADINE HYDROCHLORIDE 
fexofenadine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54868-6289(NDC:55111-784)
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 
magnesium stearate 
mannitol 
POWDERED CELLULOSE 
FD&C RED NO. 40 
HYPROMELLOSE 2910 (6 MPA.S) 
FERRIC OXIDE BLACK 
polyethylene glycol 400 
TITANIUM DIOXIDE 
STARCH, CORN 
Product Characteristics
ColorPINKScoreno score
ShapeOVALSize7mm
FlavorImprint Code194;R
Contains    
Packaging
#Item CodePackage Description
1NDC:54868-6289-030 TABLET (TABLET) in 1 BOTTLE
2NDC:54868-6289-190 TABLET (TABLET) in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07650207/27/2011
Labeler - Physicians Total Care, Inc. (194123980)
Establishment
NameAddressID/FEIOperations
Physicians Total Care, Inc.194123980relabel, repack

 
Physicians Total Care, Inc.

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Medically reviewed on Apr 25, 2018

Further information

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

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