Label: LORATADINE tablet

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

Drug Label Information

Updated January 2, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each tablet)

    Loratadine 5 mg

  • Purpose

    Antihistamine

  • Uses

    temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

    • runny nose
    • itchy, watery eyes
    • sneezing
    • 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 take more than directed. Taking more than directed 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 disintegrates, with or without water
    adults and children 6 years and over1 tablet every 12 hours; not more than 2 tablets in 24 hours
    children under 6 years of ageask a doctor
    consumers with liver or kidney diseaseask a doctor

  • Other information

    • safety sealed: do not use if the individual blister unit imprinted with Loratadine Orally disintegrating Tablet, USP is open or torn
    • store between 20° to 25°C (68° to 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?

    1-877-244-9825 - Our Medical Information center shall operate between 9:00 AM to 5:00 PM EST from Monday through Friday (business hours). Queries received outside business hours shall reach voice mail and shall be attended on next business day.

  • SPL UNCLASSIFIED SECTION

    Manufactured by:

    Tenshi Kaizen Private Limited

    Bengaluru Rural – 562112, India

    Revised: 01/2023

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    LORATADINE 
    loratadine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72983-500
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    PULLULAN (UNII: 8ZQ0AYU1TT)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    MANNITOL (UNII: 3OWL53L36A)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize12mm
    FlavorPEPPERMINTImprint Code T5
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72983-500-011 in 1 CARTON05/19/2021
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21279505/19/2021
    Labeler - Tenshi Kaizen Pvt Ltd (675478488)
    Establishment
    NameAddressID/FEIBusiness Operations
    Tenshi Kaizen Pvt Ltd675478488analysis(72983-500) , manufacture(72983-500) , pack(72983-500)
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