Label: LORATADINE capsule, liquid filled

  • NDC Code(s): 58602-818-05, 58602-818-08, 58602-818-67, 58602-818-83, view more
    58602-818-84
  • Packager: Aurohealth LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated March 24, 2023

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  • Drug Facts

    Active ingredient

     (in each capsule)

    Loratadine USP 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 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 (1-800-222-1222) 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
  • Other information

    • do not use if the individual blister unit is open or torn
    • store between 20° to 25°C (68° to 77°F)
    • protect from freezing
    • FDA approved dissolution test specifications differ from USP
  • Inactive ingredients

    Gelatin, glycerin, glyceryl monocaprylocaprate, hypromellose, isopropyl alcohol, Neelicert FD&C Blue No.1, polysorbate 80, povidone, propylene glycol, purified water, sorbitol sorbitan solution and titanium dioxide.

  • Questions or comments?

     call 1-855-274-4122 (Monday – Friday 8:30 AM to 5:00 PM EST)

    Distributed by:
    AUROHEALTH LLC
    279 Princeton-Hightstown Road
    East Windsor, NJ 08520

    Made in India

    Code: TS/DRUGS/22/2009

  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (10 Capsule Blister Carton)

    AUROHEALTH

    NDC 58602-818-83

    Compare to the active ingredient

    in Claritin® Liqui-Gels®†

    Non-Drowsy*

    Loratadine Capsules USP 10 mg

    Antihistamine

    Indoor & Outdoor Allergies

    Relief of:

    • Sneezing
    • Runny Nose
    • Itchy, Watery Eyes
    • Itchy Throat or Nose

    24 HOUR

    10 Liquid-Filled Capsules

    *When taken as directed.

    See Drug Facts Panel.

    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (10 Capsule Blister Carton)

  • INGREDIENTS AND APPEARANCE
    LORATADINE 
    loratadine capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-818
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    GELATIN TYPE B BOVINE (160 BLOOM) (UNII: 1T8387508X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONO AND DICAPRYLOCAPRATE (UNII: U72Q2I8C85)  
    HYPROMELLOSE 2910 (3 MPA.S) (UNII: 0VUT3PMY82)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POVIDONE K30 (UNII: U725QWY32X)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorBLUEScoreno score
    ShapeOVALSize11mm
    FlavorImprint Code LR10
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58602-818-831 in 1 CARTON03/24/2023
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:58602-818-672 in 1 CARTON03/24/2023
    210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:58602-818-843 in 1 CARTON03/24/2023
    310 in 1 BLISTER PACK; Type 0: Not a Combination Product
    4NDC:58602-818-084 in 1 CARTON03/24/2023
    410 in 1 BLISTER PACK; Type 0: Not a Combination Product
    5NDC:58602-818-055 in 1 CARTON03/24/2023
    510 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21190003/24/2023
    Labeler - Aurohealth LLC (078728447)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aurobindo Pharma Limited650381903ANALYSIS(58602-818) , MANUFACTURE(58602-818)
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