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Fexofenadine hydrochloride by Preferred Pharmaceuticals Inc.

Medically reviewed on May 23, 2018

Dosage form: tablet, film coated
Ingredients: FEXOFENADINE HYDROCHLORIDE 180mg
Labeler: Preferred Pharmaceuticals Inc.
NDC Code: 68788-6848

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 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 age

do not use

adults 65 years of age and older

ask a doctor

consumers with kidney disease

ask a doctor

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 tablet 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
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

Principal Display Panel


NDC 68788-6848

*Compare to 24 Hour Allegra®
Allergy active ingrediant

Original Prescription Strength Non-Drowsy

Fexofenadine Hydrochloride Tablets USP, 180 mg/antihistamine
 
Allergy
Indoor & Outdoor Allergies

24 Hours Relief of: 

 Sneezing 
 Runny nose
Itchy, Watery Eyes
Itchy Nose or Throat


DO NOT USE IF FOIL SEAL IS TORN OR MISSIN

180 mg each


Repackaged By: Preferred Pharmaceuticals Inc.

FEXOFENADINE HYDROCHLORIDE 
fexofenadine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68788-6848(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:68788-6848-330 TABLET, FILM COATED in 1 BOTTLE
2NDC:68788-6848-660 TABLET, FILM COATED in 1 BOTTLE
3NDC:68788-6848-990 TABLET, FILM COATED in 1 BOTTLE
4NDC:68788-6848-1100 TABLET, FILM COATED in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20203912/05/2016
Labeler - Preferred Pharmaceuticals Inc. (791119022)
Registrant - Preferred Pharmaceuticals Inc. (791119022)
Establishment
NameAddressID/FEIOperations
Preferred Pharmaceuticals Inc.791119022REPACK(68788-6848)

 
Preferred Pharmaceuticals Inc.

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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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