Label: ALAVERT ALLERGY- loratadine tablet, orally disintegrating

  • NDC Code(s): 80070-120-60
  • 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, colloidal silicon dioxide, corn syrup solids, crospovidone, magnesium stearate, 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 - 10 mg 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

    Fresh Mint

    60
    Orally
    Disintegrating
    Tablets

    *When taken as directed. See Drug Facts Panel.

    PRINCIPAL DISPLAY PANEL - 10 mg Tablet Blister Pack Carton
  • INGREDIENTS AND APPEARANCE
    ALAVERT   ALLERGY
    loratadine tablet, orally disintegrating
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80070-120
    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)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    CROSPOVIDONE (120 .MU.M) (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:80070-120-6060 in 1 CARTON04/02/2021
    11 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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