Label: ALAVERT ALLERGY- loratadine tablet, orally disintegrating

  • NDC Code(s): 0573-2620-01, 0573-2620-19, 0573-2620-65, 0573-2620-71, view more
    0573-2621-13, 0573-2621-19, 0573-2621-65
  • Packager: Wyeth Consumer Healthcare LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated December 4, 2017

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

  • 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

    Alavert Allergy Fresh Mint Packaging
  • 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 Citrus Burst Packaging
  • INGREDIENTS AND APPEARANCE
    ALAVERT ALLERGY 
    loratadine tablet, orally disintegrating
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0573-2620
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    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
    ColorWHITE (off white) Scoreno score
    ShapeROUND (beveled tablet) Size14mm
    FlavorMINTImprint Code A;24
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0573-2620-1918 in 1 CARTON12/19/2002
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:0573-2620-0150 in 1 BOX12/19/2002
    21 in 1 POUCH; Type 0: Not a Combination Product
    3NDC:0573-2620-6560 in 1 CARTON12/19/2002
    31 in 1 BLISTER PACK; Type 0: Not a Combination Product
    4NDC:0573-2620-711500 in 1 BOX12/19/2002
    41 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02137512/19/2002
    ALAVERT ALLERGY 
    loratadine tablet, orally disintegrating
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0573-2621
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    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
    ColorORANGE (an orange flat faced tablet) Scoreno score
    ShapeROUND (beveled tablet) Size14mm
    FlavorCITRUS (orange mint) Imprint Code A;24
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0573-2621-6560 in 1 CARTON12/19/2002
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:0573-2621-1918 in 1 CARTON12/19/2002
    21 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:0573-2621-1312 in 1 CARTON12/19/2016
    31 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02137512/19/2002
    Labeler - Wyeth Consumer Healthcare LLC (828831730)