Label: ALAVERT ALLERGY- loratadine tablet, orally disintegrating

  • NDC Code(s): 69536-190-60
  • Packager: Foundation Consumer Healthcare
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated May 1, 2024

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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

    • Place 1 tablet on tongue; tablet disentigrates with or without water.
    adults and children 6 years and over1 tablet daily; do not use more than 1 tablet in 24 hours
    children under 6 years of age ask a doctor
    consumers who have liver or kidney diseaseask a doctor
  • Other information

    • safety sealed: do not use if the individual blister unit printed with Alavert® Mint is open or torn
    • store at 20-25°C (68-77°F)
    • use tablet immediately after opening individual blister
    • complies with USP Procedure 2 for Assay and Organic Impurities and Test 2 for Disintegration
  • Inactive ingredients

    anhydrous citric acid, mannitol, peppermint flavor, polysorbate 80, pullulan

  • 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 Healthcare, LLC
    Pittsburgh, PA 15212

  • PRINCIPAL DISPLAY PANEL - 10 mg Tablet Blister Pack Carton

    NEW FORMULA

    Compare to the active ingredient in Claritin ® RediTabs ® Original Prescription Strength †

    NON-DROWSY*

    ALLERGY RELIEF

    ALAVERT ®

    Loratadine Orally Disintegrating Tablet USP, 10 mg
    Antihistamine

    Indoor/Outdoor

    ALLERGIES

    24 Hour Relief of

    Sneezing, Runny Nose

    Itchy/Watery Eyes

    Itchy Throat or Nose

    Melts In Your Mouth

    FRESH MINT Flavor

    *When taken as directed. See Drug Facts Panel.

    60 Orally Disintegrating Tablets

    Alavert - 60ct

  • INGREDIENTS AND APPEARANCE
    ALAVERT  ALLERGY
    loratadine tablet, orally disintegrating
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69536-190
    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)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    MANNITOL (UNII: 3OWL53L36A)  
    PULLULAN (UNII: 8ZQ0AYU1TT)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize12mm
    FlavorMINTImprint Code M24
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69536-190-6060 in 1 CARTON05/15/2024
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21329405/01/2024
    Labeler - Foundation Consumer Healthcare (079675882)
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