Label: ANTI-DIARRHEAL LOPERAMIDE HCL- loperamide hydrochloride capsule, liquid filled

  • NDC Code(s): 49348-752-04
  • Packager: Strategic Sourcing Services LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated October 18, 2019

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

  • Active Ingredient (in each capsule)

    Loperamide HCI 2 mg

  • Purpose

    Anti- diarrheal

  • Use

    controls symptoms of diarrhea, including Traveler's 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
    • in children under 12 years of age

    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.

  • Directions

    • drink plenty of clear fluids to help prevent dehydration caused by diarrhea
    • not for use in children under 12 years of age
    • adults and children 12 years and over: 2 softgels after the first loose stool; 1 softgel after each subsequent loose stool; but no more than 4 softgels in 24 hours
  • Other information

    • store at 20o-25oC (68o-77o F) Protect from light.
    • avoid excessive heat above 40°C (104°F).
    • do not use if carton or blister unit is open or torn
    • see side panel for lot number and expiration date
  • Inactive Ingredients

    butylated hydroxyanisole, edible ink, FDandC Blue #1, gelatin, glycerin, glyceryl caprylate, polyoxyl 40 hydrogenated castor oil and purified water.

  • Questions or comments?

    Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

  • Principal Display Panel

    COMPARE TO IMODIUM® A-D ACTIVE INGREDIENT*

    loperamide HCI, 2 mg

    Anti-Diarrheal

    Soft Gelatin Capsules

    Controls the symptoms of diarrhea

    Suitable for adults and children 12 years and over

    SOFTGELS**

    **each Liquid-capsule contains 2 mg Loperamide HCl

    THIS PRODUCT IS PACKAGED IN A CHILD RESISTANT AND TAMPER EVIDENT PACKAGE. USE ONLY IF BLISTERS ARE INTACT.

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

    **This product is not manufactured or distributed by McNeil Consumer & Specialty Pharmaceuticals, distributor of Imodium® A-D.

    Another Quality Product Distributed by McKesson

    One Post Street, San Francisco, CA 94104

    Please visit us at www.sunmarkbrand.com


  • Product Label

    Loperamide HCI 2 mg

    SUNMARK Anti-Diarrheal Capsules

  • INGREDIENTS AND APPEARANCE
    ANTI-DIARRHEAL  LOPERAMIDE HCL
    loperamide hydrochloride capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49348-752
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LOPERAMIDE HYDROCHLORIDE (UNII: 77TI35393C) (LOPERAMIDE - UNII:6X9OC3H4II) LOPERAMIDE HYDROCHLORIDE2 mg
    Inactive Ingredients
    Ingredient NameStrength
    BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorBLUEScoreno score
    ShapeCAPSULESize10mm
    FlavorImprint Code P13
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49348-752-042 in 1 BOX08/01/200612/30/2021
    112 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02185508/01/200612/30/2021
    Labeler - Strategic Sourcing Services LLC (116956644)