Label: ANTI-DIARRHEAL- loperamide hydrochloride capsule, liquid filled

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated May 19, 2022

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  • Active ingredient (in each capsule)

    Loperamide HCI 2 mg

  • Purpose

    Anti-diarrheal

  • Use

    controls symptoms of diarrhea, including Travelers' Diarrhea

  • Warnings

    Allergy alert: Do not use if you have ever had a rash or other allergic reaction to loperamide HCl

    Heart alert: Taking more than directed can cause serious heart problems or death

  • Do not use

    • if you have bloody or black stool
    • in children under 12 years of age
  • Ask a doctor before use if you have

    • fever
    • mucus in the stool
    • a history of liver disease
    • a history of abnormal heart rhythm
  • Ask a doctor or pharmacist before use if you are

    taking a prescription drug. Loperamide may interact with certain prescription drugs.

  • When using this product

    tiredness, drowsiness, or dizziness may occur. Be careful when driving or operating machinery.

  • Stop use and ask a doctor if

    • symptoms get worse
    • diarrhea lasts for more than 2 days
    • you get abdominal swelling or bulging. These may be signs of a serious condition.
  • 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

    • drink plenty of clear fluids to help prevent dehydration caused by diarrhea.
    • not for use in children under 12 years of age
    • adults and children 12 years and over: 2 capsules after the first loose stool; 1 capsule after each subsequent loose stool; but no more than 4 capsules in 24 hours
  • Other information

    • store at 20°-25°C (68°-77°F). Protect from Light.
    • avoid excessive heat above 40°C (104°F)
    • do not use if carton or blister unit is open or torn
    • see side panel for lot number and expiration date
  • Inactive ingredients

    butylated hydroxyanisole, edible ink, FD&C Blue #1, gelatin, glycerin, glyceryl caprylate, polyoxyl 40 hydrogenated castor oil, purified water

  • Questions or comments?

    call toll free 1-888-235-2466

  • SPL UNCLASSIFIED SECTION

    CardinalHealth TM

    DISTRIBUTED BY CARDINAL HEALTH

    DUBLIN, OHIO 43017

    www.myleader.com 1-800-200-6313

    Essential to Care™ since 1979

    All LEADER TM Brand Products Have A 100% Money Back Guarantee

    Return to place of purchase if not satisfied.

    †This product is not manufactured or distributed by Johnson & Johnson Consumer Inc., owner of the registered trademark Imodium ® A-D.

    © 2018 Cardinal Health. All Rights Reserved.

    CARDINAL HEALTH, the Cardinal Health LOGO,

    LEADER, and the Leader LOGO are trademarks or

    registered trademarks of Cardinal Health. All other

    marks are the property of their respective owners.

    Manufactured for:

    BIONPHARMA
    600 Alexander Road,

    Princeton, NJ 08540

    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.

    L0000566

    Lot#

    Expiration Date

    R03/22

  • Principal Display Panel

    LEADER TM

    NDC 70000-0461-1

    Anti-Diarrheal

    Loperamide Hydrochloride Capsules, 2 mg

    Controls the Symptoms of Diarrhea

    Suitable for Adults and Children

    12 years and over

    24 SOFTGELS*

    *Each Liquid-Filled Capsule

    Contains 2 mg Loperamide HCl

    Actual Size

    COMPARE TO

    IMODIUM ® A-D

    active ingredient †

    100 % Money Back Guarantee

    24's Carton

  • INGREDIENTS AND APPEARANCE
    ANTI-DIARRHEAL 
    loperamide hydrochloride capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0461
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LOPERAMIDE HYDROCHLORIDE (UNII: 77TI35393C) (LOPERAMIDE - UNII:6X9OC3H4II) LOPERAMIDE HYDROCHLORIDE2 mg
    Inactive Ingredients
    Ingredient NameStrength
    BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorblueScoreno score
    ShapeCAPSULESize10mm
    FlavorImprint Code LP2
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70000-0461-12 in 1 CARTON01/21/2019
    112 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02185501/21/2019
    Labeler - CARDINAL HEALTH (063997360)
    Registrant - Bionpharma Inc. (079637826)
    Establishment
    NameAddressID/FEIBusiness Operations
    Patheon Softgels Inc.002193829manufacture(70000-0461)
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