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

  • NDC Code(s): 41520-520-12
  • Packager: Care One (American Sales Company)
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated November 21, 2022

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  • Drug Facts

  • Active Ingredient (in each capsule)

    Loperamide HCI 2 mg

  • Purpose

    Anti- diarrheal

  • Use

    controls symptoms of diarrhea, including Traveler's 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
  • Ask a doctor or pharmacist before use if you are

    taking antibiotics

  • When using this product

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

  • Stop use and ask 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 of age and over: 2 softgels after the first loose stool; 1 softgel after each subsequent loose stool; but no more than 4 softgels in 24 hours
  • Other information

    • store at 20o-25o C (68o-77o 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 and purified water.

  • Questions or comments?

    call 1-877-753-3935- Monday-Friday 9AM-5PM EST

  • Principal Display Panel

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

    ANTI-DIARRHEAL

    2 mg Loperamide HCI

    CONTROL SYMPTOMS OF DIARRHEA

    SUITABLE FOR ADULTS AND CHILDREN

    12 YEARS AND OVER

    SOFTGELS**

    **each liquid-filled capsule contains 2 mg Loperamide HCl.

    †This product is not manufactured or distributed by McNeil Consumer & Specialty Pharmaceuticals, distributor 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

    DISTRIBUTED BY FOODHOLD U.S.A., LLC

    LANDOVER, MD 20785 • 1-877-846-9949

  • Product Label

    Loperamide HCI 2 mg

    CAREONE Anti-Diarrheal

  • INGREDIENTS AND APPEARANCE
    ANTI-DIARRHEAL 
    loperamide hydrochloride capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-520
    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 MONOCAPRYLATE (UNII: TM2TZD4G4A)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorblueScoreno score
    ShapeCAPSULESize10mm
    FlavorImprint Code P13
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41520-520-121 in 1 CARTON08/05/201005/30/2025
    112 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02185508/05/201005/30/2025
    Labeler - Care One (American Sales Company) (809183973)
    Registrant - P & L Development, LLC (079765031)
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