Label: IMODIUM A-D- loperamide hydrochloride tablet, chewable

  • NDC Code(s): 50580-397-20, 50580-397-25, 50580-397-40, 50580-397-41
  • Packager: McNeil Consumer Healthcare Div. McNeil-PPC, Inc
  • 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 11/10

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredient (in each tablet)

    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
    • take only on an empty stomach (1 hour before or 2 hours after a meal)
    • find right dose on chart. If possible, use weight to dose; otherwise, use age.
    adults and children
    12 years and over
    chew 2 tablets after the first loose stool;
    chew 1 tablet after each subsequent loose stool;
    but no more than 4 tablets in 24 hours
    children 9-11 years
    (60-95 lbs)
    chew 1 tablet after the first loose stool;
    chew ½ tablet after each subsequent loose stool;
    but no more than 3 tablets in 24 hours
    children 6-8 years
    (48-59 lbs)
    chew 1 tablet after the first loose stool;
    chew ½ tablet after each subsequent loose stool;
    but no more than 2 tablets in 24 hours
    children under 6 years
    (up to 47 lbs)
    ask a doctor
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  • Other information

    • contains milk
    • store between 20-25° C (68-77° F)
    • do not use if carton is open or if printed foil seal under bottle cap is open or torn
    • see bottom panel for lot number and expiration date
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  • Inactive ingredients

    acesulfame potassium, basic polymethacrylate, cellulose acetate, confectioner's sugar, crospovidone, D&C yellow #10 aluminum lake, dextrose excipient, FD&C blue #1 aluminum lake, flavors, magnesium stearate, microcrystalline cellulose, milk powder, sucralose

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  • Questions or comments?

    call 1-877-895-3665

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  • PRINCIPAL DISPLAY PANEL

    NDC 50580-397-20

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

    EZ CHEWS®

    Anti-Diarrheal

    Controls the symptoms
    of diarrhea

    20 Chewable
    Cool Mint Flavored Tablets

    Principal Display Panel
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  • INGREDIENTS AND APPEARANCE
    IMODIUM   A-D
    loperamide hydrochloride tablet, chewable
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:50580-397
    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
    acesulfame potassium  
    cellulose acetate  
    crospovidone  
    D&C yellow no. 10  
    aluminum oxide  
    FD&C blue no. 1  
    magnesium stearate  
    cellulose, microcrystalline  
    sucralose  
    Product Characteristics
    Color GREEN (Light green) Score 2 pieces
    Shape ROUND Size 12mm
    Flavor MINT Imprint Code IMO;2;MG
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:50580-397-20 1 in 1 CARTON
    1 20 in 1 BOTTLE, PLASTIC
    2 NDC:50580-397-25 1 in 1 CARTON
    2 25 in 1 BOTTLE, PLASTIC
    3 NDC:50580-397-40 1 in 1 CARTON
    3 40 in 1 BOTTLE, PLASTIC
    4 NDC:50580-397-41 1 in 1 CARTON
    4 50 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA020448 02/01/2007
    Labeler - McNeil Consumer Healthcare Div. McNeil-PPC, Inc (878046358)
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