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 August 18, 2016

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

    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 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. 

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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

    • store at 20º-25°C (68º-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
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  • Inactive ingredients

    butylated hydroxyanisole, edible ink, FD&C blue #1, gelatin, glycerin, glyceryl caprylate, polyoxyl 40 hydrogenated castor oil, purified water

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  • Questions or comments?

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

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  • Principal Display Panel

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

    Anti-Diarrheal

    Loperamide HCI

    Soft Gelatin Capsules, 2 mg

    Controls the Symptoms of Diarrhea

    Suitable for adults and children 12 years and over

    Softgels**

    **each liquid-filled capsule

    contains 2 mg loperamide HCI

    *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: Pharmacy Value Alliance, LLC

    407 East Lancaster Avenue,

    Wayne, PA 19087

    www.emersongroup.com

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  • Product Labeling

    Loperamide HCI 2 mg

    PREMIER VALUE Anti-Diarrheal

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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
    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 MONOCAPRYLATE (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 12/04/2012
    1 12 in 1 BLISTER PACK; Type 0: Not a Combination Product
    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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