Label: ALLERGY RELIEF- loratadine capsule, liquid filled

  • NDC Code(s): 53943-116-13
  • Packager: DISCOUNT DRUG MART, INC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated December 30, 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

    • Safety sealed: do not use if individual blister unit printed with Loratadine Capsule, 10 mg is open or torn.
    • 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)

  • SPL UNCLASSIFIED SECTION

    TAMPER EVIDENT: DO NOT USE IF CARTON IS OPEN, OR IF FOIL INNER SEAL ON BOTTLE IS BROKEN

    KEEP THIS CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

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

    Distributed by: Discount Drug Mart
    211 Commerce Drive, Medina, Ohio 44256
    www.discount-drugmart.com

    SATISFACTION GUARANTEED
    IF DISSATISFIED, RETURN UNUSED PORTION AND PACKAGE
    TO STORE WHERE PURCHASED. IF UNABLE TO RETURN TO
    STORE, SEND REASON FOR DISSATISFACTION, NAME,
    ADDRESS AND EMPTY PACKAGE TO: DISCOUNT DRUG
    MART, 211 COMMERCE DRIVE, MEDINA, OHIO 44256

    R0721


  • Principal Display Panel

    DISCOUNT

    drug

    mart

    FOOD MARKET

    AN EMPLOYEE OWNERSHIP COMPANY

    Non-Drowsy*

    NDC 53943-116-13

    24 Hour

    Allergy Relief

    Loratadine Capsules, 10 mg

    Antihistamine

    Indoor & Outdoor Allergies

    24 Hour Relief of: • Sneezing • Runny Nose • Itchy, Watery Eyes • Itchy Throat or Nose

    †Compare to the active ingredient in Claritin ® LIQUI-GELS ®

    30

    SOFTGELS**

    (**Liquid-Filled Capsules)

    *When taken as directed. See Drug Facts Panel.

    30's carton

  • INGREDIENTS AND APPEARANCE
    ALLERGY RELIEF 
    loratadine capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53943-116
    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:53943-116-131 in 1 CARTON08/20/2021
    130 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20253808/20/2021
    Labeler - DISCOUNT DRUG MART, INC. (047741335)
    Registrant - Bionpharma Inc. (079637826)
    Establishment
    NameAddressID/FEIBusiness Operations
    Patheon Softgels Inc.002193829manufacture(53943-116)
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