Label: LORATADINE capsule, liquid filled

  • NDC Code(s): 25000-021-08, 25000-021-13, 25000-021-21, 25000-021-34, view more
    25000-021-36, 25000-021-46
  • Packager: MARKSANS PHARMA LIMITED
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated November 15, 2021

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  • Active ingredient (in each capsule)


    Loratadine  10mg



  • 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

    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

    Adults and children 6 years and over: 1 capsule daily; Not more than 1 capsule in 24 hours.
    Children     under 6 years of age: ask a doctor.
    Consumers with liver or kidney disease: ask a doctor.

  • Inactive ingredients

    FD&C blue no. 1, gelatin, mono and diglyceride of caprylic/capric acid, pharmaceutical ink, polysorbate 80, povidone, purified water, sorbitol sorbitan solution.

    Questions or comments?
    Call at 1-877-376-4271


  • Other information

    • Store at 20°-25°C (68°-77°F)
    • protect from freezing.
    • Safety sealed: do not use if the individual blister unit imprinted with Loratadine Capsules is open or torn.
  • Manufactured for

    Time-Cap Labs. Inc.
    7 Michael Avenue,
    Farmingdale,
    NY 11735, USA



  • Manufactured by

    Marksans Pharma Ltd.
    Plot No. L-82, L-83,
    Verna Indl. Estate,
    Verna, GOA 403722, India.

  • Principal Display Panel

    NDC# 25000-021-13
    Loratadine Capsules, 10 mg
    600 counts Bottle Label

    600s-carton-label

    NDC# 25000-021-34
    Loratadine Capsules, 10 mg
    28 counts Blister Pack

    28-carton-label

  • PRINCIPAL DISPLAY PANEL

    NDC# 25000-021-36
    Loratadine Capsules, 10 mg
    3x10 carton Label



    3x10


  • INGREDIENTS AND APPEARANCE
    LORATADINE 
    loratadine capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:25000-021
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GELATIN (UNII: 2G86QN327L)  
    CAPRIC ACID (UNII: 4G9EDB6V73)  
    POVIDONE K30 (UNII: U725QWY32X)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SORBITAN (UNII: 6O92ICV9RU)  
    Product Characteristics
    ColorBLUE (Light Blue) Scoreno score
    ShapeOVAL (oval shaped) Size3mm
    FlavorImprint Code 21
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:25000-021-08100 in 1 BOTTLE; Type 0: Not a Combination Product10/01/2016
    2NDC:25000-021-13600 in 1 BOTTLE; Type 0: Not a Combination Product10/01/2016
    3NDC:25000-021-468 in 1 BOTTLE; Type 0: Not a Combination Product10/01/2016
    4NDC:25000-021-3428 in 1 BLISTER PACK; Type 0: Not a Combination Product10/01/2016
    5NDC:25000-021-214 in 1 BOX10/01/2016
    57500 in 1 BAG; Type 0: Not a Combination Product
    6NDC:25000-021-363 in 1 CARTON10/17/2020
    610 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20621410/01/2016
    Labeler - MARKSANS PHARMA LIMITED (925822975)
    Establishment
    NameAddressID/FEIBusiness Operations
    MARKSANS PHARMA LIMITED925822975MANUFACTURE(25000-021)
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