ALAVERT ALLERGY- loratadine tablet, orally disintegrating

ALAVERT ALLERGY by

Drug Labeling and Warnings

ALAVERT ALLERGY by is a Otc medication manufactured, distributed, or labeled by Wyeth Consumer Healthcare LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

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

When using this product

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

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

• 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

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

INGREDIENTS AND APPEARANCE

ALAVERT ALLERGY 
loratadine tablet, orally disintegrating

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0573-2620
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN)	LORATADINE	10 mg

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
ASPARTAME (UNII: Z0H242BBR1)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
CORN SYRUP (UNII: 9G5L16BK6N)
CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MANNITOL (UNII: 3OWL53L36A)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

Product Characteristics
Color	WHITE (off white)	Score	no score
Shape	ROUND (beveled tablet)	Size	14mm
Flavor	MINT	Imprint Code	A;24
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0573-2620-19	18 in 1 CARTON	12/19/2002
1		1 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 0573-2620-01	50 in 1 BOX	12/19/2002
2		1 in 1 POUCH; Type 0: Not a Combination Product
3	NDC: 0573-2620-65	60 in 1 CARTON	12/19/2002
3		1 in 1 BLISTER PACK; Type 0: Not a Combination Product
4	NDC: 0573-2620-71	1500 in 1 BOX	12/19/2002
4		1 in 1 POUCH; Type 0: Not a Combination Product

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

ALAVERT ALLERGY 
loratadine tablet, orally disintegrating

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0573-2621
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN)	LORATADINE	10 mg

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
ASPARTAME (UNII: Z0H242BBR1)
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
CORN SYRUP (UNII: 9G5L16BK6N)
CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)
ICODEXTRIN (UNII: 2NX48Z0A9G)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MANNITOL (UNII: 3OWL53L36A)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

Product Characteristics
Color	ORANGE (an orange flat faced tablet)	Score	no score
Shape	ROUND (beveled tablet)	Size	14mm
Flavor	CITRUS (orange mint)	Imprint Code	A;24
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0573-2621-65	60 in 1 CARTON	12/19/2002
1		1 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 0573-2621-19	18 in 1 CARTON	12/19/2002
2		1 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC: 0573-2621-13	12 in 1 CARTON	12/19/2016
3		1 in 1 BLISTER PACK; Type 0: Not a Combination Product

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

Labeler - Wyeth Consumer Healthcare LLC (828831730)