Label: ALAVERT ALLERGY- loratadine tablet, orally disintegrating 

  • Label RSS
  • NDC Code(s): 0573-2620-01, 0573-2620-19, 0573-2620-65, 0573-2621-19, view more
    0573-2621-65, 0573-2623-12, 0573-2624-12
  • Packager: Pfizer Consumer Healthcare
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 08/11

If you are a consumer or patient please visit this version.

  • DRUG FACTS
  • ACTIVE INGREDIENT (IN EACH TABLET)

    Loratadine 10 mg

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  • PURPOSE

    Antihistamine

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  • 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
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  • 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.

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  • 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
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  • OTHER INFORMATION

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

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  • 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

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  • QUESTIONS OR COMMENTS?

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

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  • 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 Fresh Mint Packaging
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  • 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 Citrus Burst Packaging
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  • INGREDIENTS AND APPEARANCE
    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) 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 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 3 in 1 CARTON
    1 6 in 1 BLISTER PACK
    2 NDC:0573-2620-01 50 in 1 BOX
    2 1 in 1 POUCH
    3 NDC:0573-2620-65 10 in 1 CARTON
    3 6 in 1 BLISTER PACK
    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 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) 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 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 10 in 1 CARTON
    1 6 in 1 BLISTER PACK
    2 NDC:0573-2621-19 3 in 1 CARTON
    2 6 in 1 BLISTER PACK
    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 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) 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 PINK (pink) Score no score
    Shape ROUND (beveled tablet) Size 14mm
    Flavor BUBBLE GUM (bubblegum flavor) Imprint Code A;24
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0573-2623-12 2 in 1 CARTON
    1 6 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA021375 12/19/2002 08/31/2011
    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) 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 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:0573-2624-12 2 in 1 CARTON
    1 6 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA021375 12/19/2002 04/30/2010
    Labeler - Pfizer Consumer Healthcare (828831730)
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