Label: ALAVERT ALLERGY- loratadine tablet, orally disintegrating

  • NDC Code(s): 80070-110-18, 80070-110-60
  • Packager: Foundation Consumer Brands
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated March 15, 2021

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  • SPL UNCLASSIFIED SECTION

    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.
      AgeDose
      adults and children 6 years and over1 tablet daily; do not use more than 1 tablet daily
      children under 6ask a doctor
      consumers who have liver or kidney diseaseask a doctor
  • Other information

    • phenylketonurics: contains phenylalanine 8.4 mg per tablet
    • store at 20-25°C (68-77°F)
    • keep in a dry place
  • Inactive ingredients

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

  • SPL UNCLASSIFIED SECTION

    Distributed by: Foundation Consumer Brands, LLC
    Pittsburgh, PA 15212

  • PRINCIPAL DISPLAY PANEL - 60 Tablet Blister Pack Carton

    TASTES GREAT!
    Melts in your
    Mouth!

    Compare to Claritin®†
    &
    SAVE!

    allergy

    ALAVERT®

    Loratadine Orally Disintegrating Tablet, 10 mg
    Antihistamine

    Non-Drowsy* Allergy Relief

    24
    HOUR

    Relief of

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

    *When taken as directed. See Drug Facts Panel.

    Citrus Burst

    60
    Orally
    Disintegrating
    Tablets

    PRINCIPAL DISPLAY PANEL - 60 Tablet Blister Pack Carton
  • INGREDIENTS AND APPEARANCE
    ALAVERT   ALLERGY
    loratadine tablet, orally disintegrating
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80070-110
    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 (120 .MU.M) (UNII: 68401960MK)  
    ICODEXTRIN (UNII: 2NX48Z0A9G)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MANNITOL (UNII: 3OWL53L36A)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    Product Characteristics
    ColorORANGEScoreno score
    ShapeROUND (beveled tablet) Size14mm
    FlavorCITRUS (orange mint) Imprint Code A;24
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80070-110-1818 in 1 CARTON04/02/2021
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:80070-110-6060 in 1 CARTON04/02/2021
    21 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02137504/02/2021
    Labeler - Foundation Consumer Brands (117603632)
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