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ALAVERT ALLERGY

Pfizer Consumer Healthcare

Alavert Allergy (Fresh Mint)Alavert Allergy (Citrus Burst)(loratadine)


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

DRUG FACTS

ACTIVE INGREDIENT (IN EACH TABLET)

Loratadine 10 mg

PURPOSE

Antihistamine

USES

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

  • runny nose
  • sneezing
  • itchy, watery eyes
  • itching of the nose or throat

WARNINGS

if you have ever had an allergic reaction to this product or any of its ingredients

liver or kidney disease. Your doctor should determine if you need a different dose.

do not use more than directed. Taking more than recommended may cause drowsiness.

an allergic reaction to this product occurs. Seek medical help right away.

ask a health professional before use.

In case of overdose, get medical help or contact a Poison Control Center right away.

DIRECTIONS

  • tablet melts in mouth. Can be taken with or without water.
Age Dose
adults and children 6 years and over 1 tablet daily; do not use more than 1 tablet daily
children under 6 ask a doctor
consumers who have liver or kidney disease ask a doctor

OTHER INFORMATION

  • Phenylketonurics: Contains Phenylalanine 8.4 mg per tablet
  • store at 20-25ºC (68-77ºF)
  • keep in a dry place

INACTIVE INGREDIENTS

Alavert Allergy Fresh Mint

anhydrous citric acid, aspartame, colloidal silicon dioxide, corn syrup solids, crospovidone, magnesium stearate, mannitol, microcrystalline cellulose, modified starch, natural and artificial flavors, sodium bicarbonate

Alavert Allergy Citrus Burst

anhydrous citric acid, aspartame, butylated hydroxyanisole, colloidal silicon dioxide, corn syrup solids, crospovidone, dextrin, ferric oxides, magnesium stearate, maltodextrin, mannitol, microcrystalline cellulose, modified starch, natural and artificial flavors, sodium bicarbonate

QUESTIONS OR COMMENTS?

call weekdays from 9 AM to 5 PM EST at 1-800-ALAVERT (1-800-252-8378)

PRODUCT PACKAGING

The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.

ALAVERT allergy Fresh Mint

Loratadine Orally Disintegrating Tablet, 10 mg, Antihistamine

18 Orally Disintegrating Tablets

TASTES GREAT!

Melts in your Mouth!

Non-Drowsy* Allergy Relief

*When taken as directed. See Drug Facts Panel.

24 HOUR Relief of

  • Sneezing
  • Runny Nose
  • Itchy, Watery Eyes
  • Itching of Nose & Throat

Compare to Claritin & SAVE!

Claritin is a registered trademark of Schering Corporation

Alavert Allergy provides 24 hours of allergy symptom relief without causing drowsiness when taken as directed (See Drug Facts Panel). It contains prescription strength loratadine. Just one tablet a day relieves runny nose, sneezing and itchy, watery eyes. It is safe and effective for adults and children 6 years and over. The Fresh Mint flavored tablet melts in your mouth. So convenient, it can be taken without water.

For most recent product information, visit www.alavert.com

Distributed by: Pfizer, Madison, NJ 07940 USA ©2010 Pfizer Inc.

EACH TABLET IS BLISTER SEALED. DO NOT USE IF SEAL IS BROKEN.

ALAVERT ALLERGY

PRODUCT PACKAGING

ALAVERT allergy Citrus Burst

Loratadine Orally Disintegrating Tablet, 10 mg, Antihistamine

18 Orally Disintegrating Tablets

TASTES GREAT!

Melts in your Mouth!

Non-Drowsy* Allergy Relief

*When taken as directed. See Drug Facts Panel.

24 HOUR Relief of

  • Sneezing
  • Runny Nose
  • Itchy, Watery Eyes
  • Itching of Nose & Throat

Compare to Claritin† & SAVE!

†Claritin is a registered trademark of Schering Corporation

Alavert Allergy provides 24 hours of allergy symptom relief without causing drowsiness when taken as directed (See Drug Facts Panel). It contains prescription strength loratadine. Just one tablet a day relieves runny nose, sneezing and itchy, watery eyes. It is safe and effective for adults and children 6 years and over. The Citrus Burst flavored tablet melts in your mouth. So convenient, it can be taken without water.

For most recent product information, visit www.alavert.com

Distributed by: Pfizer, Madison, NJ 07940 USA ©2010 Pfizer Inc.

EACH TABLET IS BLISTER SEALED. DO NOT USE IF SEAL IS BROKEN.

ALAVERT ALLERGY

ALAVERT ALLERGY

loratadine TABLET, ORALLY DISINTEGRATING

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0573-2620
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
LORATADINE loratadine 10 mg

Inactive Ingredients

Ingredient Name Strength
ANHYDROUS CITRIC ACID
ASPARTAME
cellulose, microcrystalline
CORN SYRUP
CROSPOVIDONE
MAGNESIUM STEARATE
mannitol
SILICON DIOXIDE
SODIUM BICARBONATE

Product Characteristics

Color Size Imprint Code Shape
WHITE (off white) 14 mm A;24 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 6 in 1 BLISTER PACK
2 1 in 1 POUCH
3 6 in 1 BLISTER PACK
4 NDC:0573-2620-65 10 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021375 2002-12-19


ALAVERT ALLERGY

loratadine TABLET, ORALLY DISINTEGRATING

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0573-2621
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
LORATADINE loratadine 10 mg

Inactive Ingredients

Ingredient Name Strength
ANHYDROUS CITRIC ACID
ASPARTAME
BUTYLATED HYDROXYANISOLE
cellulose, microcrystalline
CORN SYRUP
CROSPOVIDONE
Icodextrin
ferric oxide red
MAGNESIUM STEARATE
maltodextrin
mannitol
SILICON DIOXIDE
SODIUM BICARBONATE

Product Characteristics

Color Size Imprint Code Shape
ORANGE (an orange flat faced tablet) 14 mm A;24 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 6 in 1 BLISTER PACK
2 6 in 1 BLISTER PACK
3 NDC:0573-2621-19 3 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021375 2002-12-19


ALAVERT ALLERGY

loratadine TABLET, ORALLY DISINTEGRATING

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0573-2623
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
LORATADINE loratadine 10 mg

Inactive Ingredients

Ingredient Name Strength
ANHYDROUS CITRIC ACID
ASCORBIC ACID
ASPARTAME
cellulose, microcrystalline
CROSPOVIDONE
ferric oxide red
MAGNESIUM STEARATE
maltodextrin
mannitol
SILICON DIOXIDE
SODIUM BICARBONATE

Product Characteristics

Color Size Imprint Code Shape
PINK (pink) 14 mm A;24 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 6 in 1 BLISTER PACK
2 NDC:0573-2623-12 2 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021375 2002-12-19


ALAVERT ALLERGY

loratadine TABLET, ORALLY DISINTEGRATING

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0573-2624
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
LORATADINE loratadine 10 mg

Inactive Ingredients

Ingredient Name Strength
ANHYDROUS CITRIC ACID
ASPARTAME
BUTYLATED HYDROXYANISOLE
cellulose, microcrystalline
CORN SYRUP
CROSPOVIDONE
Icodextrin
ferric oxide red
MAGNESIUM STEARATE
maltodextrin
mannitol
SILICON DIOXIDE
SODIUM BICARBONATE

Product Characteristics

Color Size Imprint Code Shape
ORANGE (an orange flat faced tablet) 14 mm A;24 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 6 in 1 BLISTER PACK
2 NDC:0573-2624-12 2 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021375 2002-12-19


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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