Label: IMODIUM A-D- loperamide hydrochloride solution

  • NDC Code(s): 50580-134-04, 50580-134-08, 50580-134-44
  • Packager: Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated July 9, 2020

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

  • 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
    • a history of abnormal heart rhythm

    Ask a doctor or pharmacist before use if you are taking a prescription drug. Loperamide may interact with certain prescription drugs.

    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 over30 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 outer neck band imprinted with "Imodium®" or inner neck band imprinted with "Sealed For Your Safety" 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

    See New Warning
    and Directions

    NDC 50580-134-08

    Imodium®
    A-D
    Loperamide HCl, Anti-Diarrheal
    1 mg per 7.5 mL

    Anti-Diarrheal
    Oral Solution

    Controls the symptoms
    of diarrhea

    8 f l oz
    (240 mL)

    Mint Flavor

    PRINCIPAL DISPLAY PANEL
  • INGREDIENTS AND APPEARANCE
    IMODIUM   A-D
    loperamide hydrochloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50580-134
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Loperamide Hydrochloride (UNII: 77TI35393C) (Loperamide - UNII:6X9OC3H4II) Loperamide Hydrochloride1 mg  in 7.5 mL
    Inactive Ingredients
    Ingredient NameStrength
    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
    ColorGREEN (opaque) Score    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50580-134-04120 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package07/01/2004
    2NDC:50580-134-44120 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package07/01/2004
    3NDC:50580-134-08240 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package07/01/2004
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01948707/01/2004
    Labeler - Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division (878046358)