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Allergy Relief

P and L Development of New York Corporation
P and L Development of New York Corporation

DRUG FACTS


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each tablet)

Fexofenadine HCl 180 mg

Purpose

Antihistamine

Allergy Relief 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

Allergy Relief 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

Allergy Relief
Fexofenadine HCl 180 mg

Allergy Relief

Fexofenadine HCl TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:59726-189(NDC:55648-987)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
FEXOFENADINE HYDROCHLORIDE FEXOFENADINE 180 mg

Inactive Ingredients

Ingredient Name Strength
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

Color Size Imprint Code Shape
WHITE (light peach) 17 mm W987 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 5 in 1 BLISTER PACK
2 NDC:59726-189-05 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079112 2013-03-28


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Be sure to consult your doctor before taking any medication!
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