FEXOFENADINE HCL- fexofenadine hcl tablet 
Preferred Plus (Kinray)

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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:

  • 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

  • store at 20° to 25°C (68° to 77°F)
  • protect from excessive moisture

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide red, iron oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone K-30, talc, titanium dioxide

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

*Compare to the active ingredient in ALLEGRA® ALLERGY 24 HOUR

Original Prescription Strength

Fexofenadine HCl Tablets, USP 180 mg/Antihistamine

Indoor & Outdoor Allergies

Non-Drowsy 24 Hour Relief of:

  • Sneezing
  • Runny Nose
  • Itchy, Watery Eyes
  • Itchy Nose or Throat

Tablets (180 mg each)

*This product is not manufactured or distributed by Chattem Inc., distributor of Allegra® Allergy 24 Hour.

Distributed by:

Kinray Inc., 152-35 10th Ave., Whitestone, NY 11357

Product of India

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

SAFETY SEALED: DO NOT USE IF CARTON IS OPEN OR IF INNER SEAL IMPRINTED WITH "SEALED FOR YOUR PROTECTION" IS MISSING OR TORN

©2013 Kinray Inc., All Rights Reserved, PREFERRED PLUS, PREFERRED PLUS++++, and the PREFERRED PLUS logo are trademarks and/or registered trademarks of Kinray Inc. All other marks are property of their respective owners.

Product Label

Fexofenadine HCL 180 mg

Preferred Plus Fexofenadine HCL Tablets

 

FEXOFENADINE HCL 
fexofenadine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61715-049
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)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE (UNII: FZ989GH94E)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorWHITEScoreno score
ShapeCAPSULESize17mm
FlavorImprint Code W987
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61715-049-301 in 1 BOX03/31/201312/31/2019
130 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07911203/31/201312/31/2019
Labeler - Preferred Plus (Kinray) (012574513)

Revised: 8/2019
Document Id: e6ab3e06-52e9-472e-9960-b1a17ab92db8
Set id: 3329858a-15f6-439a-9803-63dbe954583c
Version: 2
Effective Time: 20190821
 
Preferred Plus (Kinray)