Label: LORATADINE 10MG tablet

  • NDC Code(s): 25000-092-03, 25000-092-79, 25000-092-80, 25000-092-81
  • Packager: MARKSANS PHARMA LIMITED
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated November 25, 2024

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  • ACTIVE INGREDIENT(S)

    Active ingredient (in each tablet)
    Loratadine USP, 10 mg

  • PURPOSE

    Purpose 
    Antihistamine

  • USE(S)

    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

    Warnings

  • DO NOT USE

    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

    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

    When using this product do not take more than directed. Taking more than directed may cause drowsiness.

  • STOP USE AND ASK DOCTOR IF

    Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

  • PREGNANCY/BREASTFEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). 

  • DIRECTIONS

    Directions

    adults and children 6 years and over  1 tablet daily; not more than 1 tablet in 24 hours 
     children under 6 years of age ask a doctor
     consumers with liver or kidney disease ask a doctor



  • OTHER REQUIRED WARNINGS

    Other information

    • For Bottle pack: Tamper-evident: do not use this product if the imprinted foil seal over the mouth of the bottle is cut, torn, broken or missing.
    • For Blister pack: Tamper-evident: do not use if the individual blister unit is open or torn
    • store between 20º to 25º C (68º to 77º F)
    • FDA approved dissolution test specifications differ from USP
  • Inactive ingredients

    Inactive ingredients colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate

  • Questions or comments?

    Questions or comments? Call 1-877-376-4271 (weekdays 9 AM to 5 PM)

    Manufactured for:
    Time-Cap Labs, Inc. 
    7 Michael Avenue, 
    Farmingdale, 
    NY 11735

    Manufactured by: 
    Marksans Pharma Ltd.
    Plot No. L-82, L-83
    Verna Indl. Estate
    Verna, Goa-403722 

    Made in India

  • PRINCIPAL DISPLAY PANEL

    NDC: 25000-092-81
    Loratadine Tablets USP, 10 mg
    14's count Carton


    loratadine-tablets-14ct-blister-carton


    NDC: 25000-092-03
    Loratadine Tablets USP, 10 mg
    30's count Carton


    loratadine-tablets-30ct-carton


    NDC: 25000-092-03
    Loratadine Tablets USP, 10 mg
    30's count Label


    loratadine-tablets-30-ct-label


    NDC: 25000-092-79
    Loratadine Tablets USP, 10 mg
    150's count Carton


    loratadine-tablets-150ct-carton


    NDC: 25000-092-79
    Loratadine Tablets USP, 10 mg
    150's count Label


    loratadine-tablets-150ct-label


    NDC: 25000-092-80
    Loratadine Tablets USP, 10 mg
    365's count Label


    loratadine-tablets-365ct-label


  • INGREDIENTS AND APPEARANCE
    LORATADINE 10MG 
    loratadine 10mg tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:25000-092
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE 101 (UNII: 7T9FYH5QMK)  
    SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
    Product Characteristics
    ColorWHITE (White to off-white) Scoreno score
    ShapeROUNDSize6mm
    FlavorImprint Code 92
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:25000-092-031 in 1 CARTON11/21/2024
    130 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:25000-092-791 in 1 CARTON11/21/2024
    2150 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:25000-092-812 in 1 CARTON11/21/2024
    37 in 1 BLISTER PACK; Type 0: Not a Combination Product
    4NDC:25000-092-80365 in 1 BOTTLE; Type 0: Not a Combination Product11/21/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21922311/21/2024
    Labeler - MARKSANS PHARMA LIMITED (925822975)
    Establishment
    NameAddressID/FEIBusiness Operations
    MARKSANS PHARMA LIMITED925822975MANUFACTURE(25000-092)
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