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 12/12

If you are a consumer or patient please visit this version.

  • Drug Facts
  • Active Ingredient (in each capsule)

    Loperamide HCI 2 mg

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  • Purpose

    Anti- diarrheal

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  • Use

    controls symptoms of diarrhea, including Traveler's Diarrhea

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  • Warnings

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

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  • Do not use

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  • Ask a doctor before use if you have

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

    taking antibiotics

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  • When using this product

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

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  • 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.
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  • If pregnant or breast-feeding,

    ask a health professional before use.

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  • Keep out of reach of children

    In case of overdose, get medical help or contact a Poison Control Center right away

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  • 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
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  • Other information

    • do not use if carton or blister unit is open or torn
    • store at 20o-25o C (68o-77o F)
    • avoid excessive heat above 40°C (104°F).
    • see side panel for lot number and expiration date
    • use the 1 mg soft gelatin capsule product for children 6 to under 12 years of age
    • **This product is not manufactured or distributed by McNeil Consumer and Specialty Pharmaceuticals, owner of the registered trademark of Imodium® A-D.

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  • Inactive Ingredients

    butylated hydroxyanisole, edible ink, FD&C Blue #1, gelatin, glycerin, glyceryl caprylate, polyoxyl 40 hydrogenated castor oil and purified water. Close
  • Questions or comments?

    call toll free 1-800-447-1140
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  • Principal Display Panel

    COMPARE TO ACTIVE INGREDIENT IN IMODIUM® A-D **

    Anti-Diarrheal

    Soft Gelatin Capsules, 2 mg

    Loperamide HCl

    Controls the symptoms of diarrhea

    Suitable for adults and children 12 years and over

    LIQUID- FILLED SOFTGELS*

    *each liquid-capsule contains 2 mg Loperamide HCl

    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: American Sales Company

    4201 walden ave, Lancaster, NY 14086

    Manufactured by: Banner Pharmacaps Inc.

    4125 Premier drive, High point, NC 27265

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  • Product Label

    CareOne

    Loperamide HCl 2 mg

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  • INGREDIENTS AND APPEARANCE
    ANTI-DIARRHEAL 
    loperamide hydrochloride capsule, liquid filled
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:41520-520(NDC:10888-7098)
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    LOPERAMIDE HYDROCHLORIDE (UNII: 77TI35393C) (LOPERAMIDE - UNII:6X9OC3H4II) LOPERAMIDE HYDROCHLORIDE 2 mg
    Inactive Ingredients
    Ingredient Name Strength
    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
    Color BLUE Score no score
    Shape CAPSULE Size 10mm
    Flavor Imprint Code P13
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:41520-520-12 1 in 1 CARTON
    1 12 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA021855 08/05/2010
    Labeler - Care One (American Sales Company) (809183973)
    Registrant - P and L Development of New York Corporation (800014821)
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