Label: LORATADINE capsule, liquid filled

  • NDC Code(s): 69452-283-17, 69452-283-19, 69452-283-25
  • Packager: Bionpharma Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated December 29, 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

    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

    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

    • Tamper-evident: do not use if foil seal under cap, printed with “Sealed for your protection” is missing, open or broken. (For Bottle Labels and Cartons)
    • Safety sealed: do not use if individual blister unit printed with Loratadine Capsule, 10 mg is open or torn. (For Blister Carton)
    • store between 20° to 25°C (68° to 77°F)
    • protect from freezing
  • Inactive ingredients

    FD&C blue no.1, gelatin, glycerin, hypromellose, hydrolyzed collagen, isopropyl alcohol, mannitol, medium chain mono- & di-glycerides, propylene glycol, purified water, sorbitan, sorbitol, titanium dioxide

  • Questions or comments?

    call toll free 1-888-235-2466 (Mon - Fri 9AM - 5PM EST)

    †This product is not manufactured or distributed by the owners of Claritin® LIQUI-GELS®.

    Blister carton contain the following:

    THIS PRODUCT IS PACKAGED IN A CHILD-RESISTANT AND TAMPER EVIDENT PACKAGE. USE ONLY IF BLISTERS ARE INTACT.
    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

    Do not use if carton is open, or if individual blister unit is open or torn

    Manufactured for:

    Bionpharma Inc.

    600 Alexander Road,

    Princeton, NJ 08540

  • Principal Display Panel

    5's Carton

  • INGREDIENTS AND APPEARANCE
    LORATADINE 
    loratadine capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69452-283
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    CAPRYLIC/CAPRIC MONO/DI-GLYCERIDES (UNII: U72Q2I8C85)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    HYDROLYSED BOVINE COLLAGEN (ENZYMATIC; 2000-5000 MW) (UNII: 5WE8P977RQ)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    MANNITOL (UNII: 3OWL53L36A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITAN (UNII: 6O92ICV9RU)  
    SORBITOL (UNII: 506T60A25R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorblueScoreno score
    ShapeOVALSize10mm
    FlavorImprint Code L10
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69452-283-191 in 1 CARTON03/20/2020
    190 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:69452-283-25180 in 1 BOTTLE; Type 0: Not a Combination Product03/20/2020
    3NDC:69452-283-171 in 1 CARTON08/26/2021
    360 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20253803/20/2020
    Labeler - Bionpharma Inc. (079637826)
    Registrant - Bionpharma Inc. (079637826)
    Establishment
    NameAddressID/FEIBusiness Operations
    Patheon Softgels Inc.002193829manufacture(69452-283)
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