Label: LOPERAMIDE HCL- loperamide hydrochloride capsule, liquid filled 

  • Label RSS
  • NDC Code(s): 68016-193-12
  • Packager: Chain Drug Consortium, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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 LABEL Item Code (Source) NDC:68016-193
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE) LOPERAMIDE HYDROCHLORIDE 2 mg
    Inactive Ingredients
    Ingredient Name Strength
    BUTYLATED HYDROXYANISOLE  
    FD&C BLUE NO. 1  
    GELATIN  
    GLYCERIN  
    GLYCERYL CAPRYLATE  
    POLYOXYL 40 HYDROGENATED CASTOR OIL  
    WATER  
    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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