Label: LORATADINE capsule, liquid filled

  • NDC Code(s): 59556-882-01, 59556-882-81
  • Packager: Strides Pharma Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated March 28, 2022

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  • Active ingredient (in each capsule)

    Loratadine 10 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

    OTC - DO NOT USE

    Do not use if you have ever had an allergic reaction to this product or any of its ingredients.

    OTC - ASK DOCTOR

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

    OTC - WHEN USING

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

    OTC - STOP USE

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

    OTC - PREGNANCY OR BREAST FEEDING

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

    OTC - 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.

  • 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

    • safety sealed: do not use if the  individual  blister unit imprinted with Loratadine capsule is open or torn
    • store between 20° to 25°C (68° to 77°F)
    • protect from freezing
  • Inactive ingredients

    FD & C Blue 1, Gelatin, Glycerin, Glyceryl Monocaprylocaprate, Isopropyl alcohol, Medium chain triglyceride, Polysorbate 80, Povidone K-30, Purified Water, Soya Lecithin, Sorbitol Solution,

    Printing ink white-edible oil-Dewaxed Bleached Shellac Resins, Propylene Glycol, Sodium Lauryl Sulphate, Titanium Dioxide

    .

  • Questions or comments?

    Strides Pharma Inc. at 1-877-244-9825 or go to www.strides.com

    Manufactured by:

    Strides Pharma Science Limited

    Bengaluru – 562106, India.

    Distributed by:

    Strides Pharma Inc.

    East Brunswick, NJ 08816

    Revised: 01/2020

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    carton-label-10s
  • INGREDIENTS AND APPEARANCE
    LORATADINE 
    loratadine capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59556-882
    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)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL CAPRYLATE/CAPRATE (UNII: G7515SW10N)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    NONCRYSTALLIZING SORBITOL SOLUTION (UNII: 9E0S3UM200)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POVIDONE K30 (UNII: U725QWY32X)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHELLAC (UNII: 46N107B71O)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorBLUEScoreno score
    ShapeOVALSize10mm
    FlavorImprint Code 10
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59556-882-813 in 1 CARTON06/01/2021
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:59556-882-011 in 1 CARTON06/01/2021
    210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21192606/01/2021
    Labeler - Strides Pharma Inc (078868278)
    Registrant - Strides Pharma Science Limited (650738743)
    Establishment
    NameAddressID/FEIBusiness Operations
    Strides Pharma Science Limited918513263ANALYSIS(59556-882) , MANUFACTURE(59556-882) , PACK(59556-882)
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