Label: LORATADINE tablet, orally disintegrating

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated May 7, 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 useif you have ever had an allergic reaction to this product or any of its ingredients

    Ask a doctor before use if you haveliver or kidney disease. Your doctor should determine if you need a different dose.

    When using this productdo not use more than directed. Taking more than recommended may cause drowsiness.

    Stop use and ask a doctor ifan 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 ageask 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 Loratadine orally disintegrating tablet 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 Toll-free weekdays 9 AM to 5 PM EST at 1-888-375-3784

  • SPL UNCLASSIFIED SECTION

    Manufactured By: Tenshi Kaizen Private Limited

    Bengaluru Rural - 562112, India

  • PRINCIPAL DISPLAY PANEL - 10 mg Tablet Blister Pack Carton

    NEW FORMULA

    NON-DROWSY*

    ALLERGY RELIEF

    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

    loratadine-carton

  • INGREDIENTS AND APPEARANCE
    LORATADINE 
    loratadine tablet, orally disintegrating
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72983-503
    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
    Colorwhite (white to off- white) Scoreno score
    ShapeROUNDSize12mm
    FlavorMINTImprint Code M24
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72983-503-0660 in 1 CARTON05/07/2024
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21329405/07/2024
    Labeler - Tenshi Kaizen Pvt Ltd (675478488)
    Establishment
    NameAddressID/FEIBusiness Operations
    Tenshi Kaizen Pvt Ltd675478488analysis(72983-503) , manufacture(72983-503) , pack(72983-503)
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