Label: LOPERAMIDE HCL- loperamide hydrochloride capsule, liquid filled

  • NDC Code(s): 68016-193-12
  • Packager: Chain Drug Consortium, LLC
  • 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.

  • 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 Travelers'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

    • if you have bloody or black stool
    • in children under 12 years of age (see Other Information)
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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.
    • side effects occur. You may want to report side effects to FDA at 1800-FDA-1088.
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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 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 20-25°C (68-77°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
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  • Inactive ingredients

    Butylated hydroxyanisole, edible ink FDandC blue #1, Gelatin, Glycerin, Glyceryl Caprylate, Polyoxyl 40 hydrogenated castor oil and purified water.
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  • Product Labeling

    Premier Value
    Compare to the active ingredient in Imodium(r) A-D

    Anti-Diarrheal
    Loperamide HCl
    Soft gelatin capsules, 2mg

    Controls the Symptoms of Diarrhea
    suitable for adults and children 12 years and over

    12 softgels

    Distributed by: Chan Drug Consortium, LLC
    3301 NW Boca Raton Blvd. Suite 101
    Boca Raton, FL 33431

    Manufactured by
    Banner Pharmacaps, Inc.
    4215 Premier Drive
    High Point, NC 27265

    **This product is not manufactured or distributed by McNeil Consumer and Specialty Pharmaceuticals, owner of ther egistered trademark of Imodium (r) A-D.

    Loperamide HCl

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  • INGREDIENTS AND APPEARANCE
    LOPERAMIDE HCL 
    loperamide hydrochloride capsule, liquid filled
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:68016-193
    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 9mm
    Flavor Imprint Code p13
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:68016-193-12 2 in 1 BOX
    1 12 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA021855 12/04/2012
    Labeler - Chain Drug Consortium, LLC (101668460)
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