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Imodium (McNeil Consumer Healthcare Div McNeil-PPC, Inc)

Available Formats

Dosage Form Package Information Links
LIQUID 240 mL in 1 BOTTLE (50580-134-08) Label Information
LIQUID 120 mL in 1 BOTTLE (50580-134-04) Label Information
LIQUID 120 mL in 1 BOTTLE (50580-134-44) Label Information

Complete Imodium Information

  • SPL UNCLASSIFIED SECTION

    Drug Facts


  • Active ingredient (in each 7.5 mL)

    Loperamide HCl 1 mg


  • Purpose

    Anti-diarrheal


  • Use

    controls symptoms of diarrhea, including Travelers' Diarrhea


  • Warnings

    Allergy alert

    Do not use if you have ever had a rash or other allergic reaction to loperamide HCl

    Heart alert

    Taking more than directed can cause serious heart problems or death

    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)


  • 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.
    • shake well before using
    • use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.
    • mL = milliliter
    adults and children 12 years and over 30 mL after the first loose stool; 15 mL after each subsequent loose stool; but no more than 60 mL in 24 hours
    children 9-11 years (60-95 lbs) 15 mL after first loose stool; 7.5 mL after each subsequent loose stool; but no more than 45 mL in 24 hours
    children 6-8 years (48-59 lbs) 15 mL after first loose stool; 7.5 mL after each subsequent loose stool; but no more than 30 mL in 24 hours
    children 2-5 years (34 to 47 lbs) ask a doctor
    children under 2 years (up to 33 lbs) do not use

  • Other information

    • each 30 mL contains: sodium 16 mg
    • store between 20-25°C (68-77°F)
    • do not use if printed inner or outer neckband is broken or missing.

  • Inactive ingredients

    anhydrous citric acid, caramel color, D&C yellow no. 10, FD&C blue no. 1, flavor, glycerin, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, purified water, simethicone emulsion, sodium benzoate, sucralose, titanium dioxide, xanthan gum


  • Questions or comments?

    call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)


  • PRINCIPAL DISPLAY PANEL

    NDC 50580-134-04

    See New Warning
    and Directions

    Imodium®
    A-D

    Loperamide HCl, Anti-Diarrheal
    1 mg per 7.5 mL

    Anti-Diarrheal
    Oral Solution

    Controls the symptoms
    of diarrhea

    4 fl oz
    (120 mL)

    Mint Flavor

    PRINCIPAL DISPLAY PANEL

  • INGREDIENTS AND APPEARANCE
    IMODIUM   A-D
    loperamide hydrochloride solution
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:50580-134
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Loperamide Hydrochloride (UNII: 77TI35393C) (Loperamide - UNII:6X9OC3H4II) Loperamide Hydrochloride 1 mg  in 7.5 mL
    Inactive Ingredients
    Ingredient Name Strength
    anhydrous citric acid (UNII: XF417D3PSL)  
    carboxymethylcellulose sodium, unspecified form (UNII: K679OBS311)  
    caramel (UNII: T9D99G2B1R)  
    D&C yellow no. 10 (UNII: 35SW5USQ3G)  
    FD&C blue no. 1 (UNII: H3R47K3TBD)  
    glycerin (UNII: PDC6A3C0OX)  
    microcrystalline cellulose (UNII: OP1R32D61U)  
    propylene glycol (UNII: 6DC9Q167V3)  
    sodium benzoate (UNII: OJ245FE5EU)  
    sucralose (UNII: 96K6UQ3ZD4)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    water (UNII: 059QF0KO0R)  
    xanthan gum (UNII: TTV12P4NEE)  
    Product Characteristics
    Color GREEN (opaque) Score     
    Shape Size
    Flavor MINT Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:50580-134-04 120 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package 07/01/2004
    2 NDC:50580-134-44 120 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package 07/01/2004
    3 NDC:50580-134-08 240 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package 07/01/2004
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA019487 07/01/2004
    Labeler - Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division (878046358)