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Fexofenadine hydrochloride by Bryant Ranch Prepack

Dosage form: tablet, film coated
Ingredients: FEXOFENADINE HYDROCHLORIDE 180mg
Labeler: Bryant Ranch Prepack
NDC Code: 71335-0483

Active ingredient(in each tablet)

Fexofenadine HCl USP, 180 mg

Fexofenadine HCl USP, 60 mg


Purpose

Antihistamine

Uses

temporarily relieves these symptoms due to hay fever or other upper resporatory 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 aluminium or magnesium antacids
  • do not take with fruit juices (see directions)

Stop use and ask 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

adults and children 12 years of age and overtake one 60 mg tablet with water every 12 hours;
do not take more than 2 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 printed foil inner seal on bottle is torn or missing
  • store between 20°and 25°C (68°and 77°F)
  • protect from excessive moisture and light

Inactive ingredients

anhydrous lactose, colloidal silicon dioxide, corn starch,croscarmellose sodium, hypromellose, lactose monohydrate, polyethylene glycol 400, pregelatinized corn starch, red iron oxide, steric acid, titanium dioxide, and yellow iron oxide,

Questions or comments?

 call 1-855-274-4122

HOW SUPPLIED

Product: 71335-0483

NDC: 71335-0483-6 180 TABLET, FILM COATED in a BOTTLE

NDC: 71335-0483-7 100 TABLET, FILM COATED in a BOTTLE

NDC: 71335-0483-4 90 TABLET, FILM COATED in a BOTTLE

NDC: 71335-0483-1 30 TABLET, FILM COATED in a BOTTLE

NDC: 71335-0483-2 15 TABLET, FILM COATED in a BOTTLE

NDC: 71335-0483-5 5 TABLET, FILM COATED in a BOTTLE

NDC: 71335-0483-3 60 TABLET, FILM COATED in a BOTTLE

Fexofenadine Hcl 180mg Tablet
FEXOFENADINE HYDROCHLORIDE 
fexofenadine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71335-0483(NDC:58602-711)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE) FEXOFENADINE HYDROCHLORIDE180 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS LACTOSE 
SILICON DIOXIDE 
CROSCARMELLOSE SODIUM 
HYPROMELLOSE, UNSPECIFIED 
LACTOSE MONOHYDRATE 
STARCH, CORN 
STEARIC ACID 
FERRIC OXIDE RED 
FERRIC OXIDE YELLOW 
POLYETHYLENE GLYCOL 400 
TITANIUM DIOXIDE 
Product Characteristics
ColorORANGE (Peach) Scoreno score
ShapeCAPSULE (Bevel Edge, Biconvex) Size17mm
FlavorImprint CodeE;44
Contains    
Packaging
#Item CodePackage Description
1NDC:71335-0483-6180 TABLET, FILM COATED in 1 BOTTLE
2NDC:71335-0483-7100 TABLET, FILM COATED in 1 BOTTLE
3NDC:71335-0483-490 TABLET, FILM COATED in 1 BOTTLE
4NDC:71335-0483-130 TABLET, FILM COATED in 1 BOTTLE
5NDC:71335-0483-215 TABLET, FILM COATED in 1 BOTTLE
6NDC:71335-0483-55 TABLET, FILM COATED in 1 BOTTLE
7NDC:71335-0483-360 TABLET, FILM COATED in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20203901/15/2015
Labeler - Bryant Ranch Prepack (171714327)
Establishment
NameAddressID/FEIOperations
Bryant Ranch Prepack171714327REPACK(71335-0483), RELABEL(71335-0483)

Revised: 12/2017
 
Bryant Ranch Prepack

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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