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 December 26, 2023

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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 capsules 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(Mon - Fri 9AM - 5PM EST)

  • SPL UNCLASSIFIED SECTION

    †This product is not manufactured or distributed by the owners of Imodium ®A-D

    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.

    Manufactured for:

    BIONPHARMA
    Princeton, NJ 08540

    R0223

  • Principal Display Panel

    NDC 69452-266-12

    a+health

    †Compare to the active ingredient in Imodium ®A-D

    loperamide HCl capsules, 2 mg

    Anti-Diarrheal

    Controls the Symptoms of Diarrhea

    Suitable for Adults and Children 12 Years and Over

    24 Softgels*

    *soft gelatin liquid-filled capsules

    each softgel contains 2 mg loperamide HCl

    carton

  • INGREDIENTS AND APPEARANCE
    ANTI-DIARRHEAL 
    loperamide hydrochloride capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69452-266
    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:69452-266-122 in 1 CARTON03/20/2020
    112 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02185508/02/2019
    Labeler - Bionpharma Inc. (079637826)
    Registrant - Bionpharma Inc. (079637826)
    Establishment
    NameAddressID/FEIBusiness Operations
    Patheon Softgels Inc.002193829manufacture(69452-266)
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