FEXOFENADINE HYDROCHLORIDE - fexofenadine hydrochloride tablet, film coated 
Dispensing Solutions, Inc.

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Major Pharmaceuticals Fexofenadine Hydrochloride Tablets, 180 mg Drug Facts

Active ingredient (in each tablet)

Fexofenadine HCl 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

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. (1-800-222-1222)

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


Other information

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, titanium dioxide

Questions or comments?

1-800-719-9260

Package/Label Principal Display Panel


NDC 66336-0561-XX

NDC 66336-0561-XX
NDC 66336-0561-30


COMPARE TO active ingredient of  ALLEGRA® ALLERGY TABLETS

Original Prescription Strength

FEXOFENADINE HYDROCHLORIDE TABLETS, 180 mg

Antihistamine
ALLERGY

Relief of:

Sneezing

Runny Nose

Itchy, Watery Eyes

Itchy Nose or Throat

Indoor and Outdoor Allergies

24 HOUR

Non-Drowsy

actual size

180 mg EACH
FEXOFENADINE HYDROCHLORIDE 
fexofenadine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66336-561(NDC:0904-6214)
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)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
POVIDONE (UNII: FZ989GH94E)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
Colororange (peach) Scoreno score
ShapeROUNDSize12mm
FlavorImprint Code 93;7253
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66336-561-3030 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07644704/14/2011
Labeler - Dispensing Solutions, Inc. (066070785)
Registrant - PSS World Medical, Inc. (101822682)
Establishment
NameAddressID/FEIBusiness Operations
Dispensing Solutions, Inc.066070785relabel, repack

Revised: 2/2012
Document Id: 7c798476-f38e-40df-8755-a0edc055ec21
Set id: 2308ac2f-e152-42d5-8c75-3b776af51f1d
Version: 1
Effective Time: 20120203
 
Dispensing Solutions, Inc.