Your browser does not support JavaScript! ALLERGY RELIEF (FEXOFENADINE HCL) TABLET [P AND L DEVELOPMENT OF NEW YORK CORPORATION]
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ALLERGY RELIEF (fexofenadine hcl) tablet
[P and L Development of New York Corporation]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL Abbreviated New Drug Application
Drug Label Sections

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 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

  • store at 20°-25°C (68°-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 toll free 1-877-753-3935 Monday- Friday 9AM- 5PM EST

Package/Label Principal Display Panel

†Compare to the active ingredient in Allegra® Allergy 24 hour

ORIGINAL PRESCRIPTION STRENGTH

NON-DROWSY

ALLERGY RELIEF

Fexofenadine HCl 180 mg

Antihistamine

ALLERGY

Indoor and outdoor Allergies

24 Hour Relief of:

  • sneezing
  • runny nose
  • itchy, watery eyes
  • itchy nose or throat

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

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

DO NOT USE IF CARTON IS OPEN OR IF INDIVIDUAL BLISTER UNIT IS TORN OR OPEN.

Distributed by: PL Developments

200 hicks street

westbury NY 11590

PRODUCT OF INDIA

Product Label

PL Developments

Fexofenadine HCl 180 mg

ALLERGY RELIEF 
fexofenadine hcl tablet
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:59726-189(NDC:55648-987)
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 
HYPROMELLOSES 
FERRIC OXIDE RED 
FERRIC OXIDE YELLOW 
LACTOSE MONOHYDRATE 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOLS 
POVIDONE K30 
TALC 
TITANIUM DIOXIDE 
Product Characteristics
ColorWHITE (light peach) Scoreno score
ShapeCAPSULESize17mm
FlavorImprint Code W987
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59726-189-051 in 1 CARTON
15 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07911203/28/2013
Labeler - P and L Development of New York Corporation (800014821)
Registrant - P and L Development of New York Corporation (800014821)

Revised: 12/2012
 
P and L Development of New York Corporation

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