Label: LOPERAMIDE HYDROCHLORIDE solution

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated March 20, 2026

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each 7.5 mL)

    Loperamide HCl, USP 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 useif 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 aretaking a prescription drug. Loperamide may interact with certain prescription drugs.

    When using this producttiredness, 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 years to 11 years (60 lbs to 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 years to 8 years (48 lbs to 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 years to 5 years (34 lbs to 47 lbs)ask a doctor
    children under 2 years (up to 33 lbs)do not use

  • Other information

    • each 30 mL contains: sodium 7 mg
    • store at 20°C to 25°C (68°F to 77°F)
    • do not use if outer neck band is broken or missing.
  • Inactive ingredients

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

  • Questions or comments?

    call toll-free 1-888-235-2466

  • SPL UNCLASSIFIED SECTION

    Do not use if outer neck bandis broken or missing

    PEEL OPEN TO READ COMPLETE DIRECTIONS AND WARNINGS BEFORE PURCHASE

    *This product is not manufactured or distributed by the owners of Imodium ®A-D.

    DISTRIBUTED BY OLD EAST MAIN CO.

    100 MISSION RIDGE

    GOODLETTSVILLE, TN 37072

    MADE IN INDIA

    100% Satisfaction Guaranteed!

    (888) 309-9030

    984006960

    L0001226 R0226 A1791

    Code: TN/Drugs/TN00002222/2006

  • PRINCIPAL DISPLAY PANEL-4 fl oz

    DG TM health

    *Compare to the active ingredient ofImodium ®A-D

    children's

    For Ages 6

    Years and Up

    Anti-Diarrheal

    Loperamide Hydrochloride

    Oral Solution, USP 1 mg per 7.5 mL

    Controls the symptoms of diarrhea

    Mint Flavor

    4 fl oz (120 mL)

    image01

  • INGREDIENTS AND APPEARANCE
    LOPERAMIDE HYDROCHLORIDE 
    loperamide hydrochloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-155
    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)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    CARAMEL (UNII: T9D99G2B1R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMINT (flavadew coolmint) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55910-155-55120 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2026
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA22010003/30/2026
    Labeler - DOLGENCORP INC (068331990)
    Registrant - Bionpharma Inc. (079637826)
    Establishment
    NameAddressID/FEIBusiness Operations
    OrBion Pharmaceuticals Private Limited854403569manufacture(55910-155)
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