Label: IMODIUM AD- loperamide hydrochloride tablet, coated 

  • Label RSS
  • 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 01/13

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredient (in each caplet)

    Loperamide HCl 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

    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. (1-800-222-1222)

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  • Directions

    • drink plenty of clear fluids to help prevent dehydration caused by diarrhea
    • find right dose on chart. If possible, use weight to dose; otherwise, use age.
    adults and children 12 years and over 2 caplets after the first loose stool;
    1 caplet after each subsequent loose stool; but no more than 4 caplets in 24 hours
    children 9-11 years
    (60-95 lbs)
    1 caplet after the first loose stool;
    1/2 caplet after each subsequent loose stool; but no more than 3 caplets in 24 hours
    children 6-8 years
    (48-59 lbs)
    1 caplet after the first loose stool;
    1/2 caplet after each subsequent loose stool; but no more than 2 caplets in 24 hours
    children under 6 years
    (up to 47 lbs)
    ask a doctor
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  • Other information

    • each caplet contains: calcium 10 mg
    • store between 20-25°C (68-77°F)
    • do not use if carton or pouch is open or torn
    • see bottom panel for lot number and expiration date
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  • Inactive ingredients

    colloidal silicon dioxide, dibasic calcium phosphate dihydrate, D&C yellow no.10 aluminum lake, FD&C blue no.1 aluminum lake, magnesium stearate, microcrystalline cellulose

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  • Questions or comments?

    call 1-877-895-3665

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  • SPL UNCLASSIFIED SECTION

    Repackaged and distributed with permission of manufacturer by:
    Lil' Drug Store Products, Inc.
    1201 Continental Place NE, Cedar Rapids, IA 52402

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  • PRINCIPAL DISPLAY PANEL - 2 caplet carton

    Imodium®
    A-D
    Loperamide HCl, 2 mg
    Anti-Diarrheal

    Anti-Diarrheal

    Controls the symptoms
    of diarrhea

    2 CAPLETS

    Lil'
    Drug Store®

    Principal Display Panel - 2 caplet carton
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  • INGREDIENTS AND APPEARANCE
    IMODIUM AD 
    loperamide hydrochloride tablet, coated
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:66715-9720(NDC:50580-295)
    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
    silicon dioxide  
    calcium phosphate, dibasic, dihydrate  
    D&C yellow no. 10  
    aluminum oxide  
    FD&C blue no. 1  
    magnesium stearate  
    cellulose, microcrystalline  
    Product Characteristics
    Color GREEN (Light Green) Score no score
    Shape OVAL (Capsule shaped) Size 15mm
    Flavor Imprint Code IMODIUM;A;D;2MG
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:66715-9720-1 1 in 1 CARTON
    1 2 in 1 POUCH
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA019860 05/10/2010
    Labeler - Lil' Drug Store Products, Inc. (093103646)
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