Label: LOPERAMIDE HYDROCHLORIDE capsule, liquid filled

  • NDC Code(s): 59556-959-03, 59556-959-05, 59556-959-06
  • Packager: Strides Pharma Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated October 22, 2021

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  • Active Ingredient (in each capsule)

    Loperamide Hydrochloride USP, 2 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
    • in children under 12 years of age
  • Ask a doctor before use if you have

    • fever
    • mucus in 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.

  • 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 20°-25°C (68°-77°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, FD&C Blue #1, gelatin, glycerol, glyceryl mono caprylo caprate, polyoxyl 40 hydrogenated castor oil, purified water,

    printing ink white-edible oil – dewaxed bleached shellac resins, propylene glycol, sodium lauryl sulphate, titanium dioxide.                         

  • Questions or comments?

    go to www.strides.com or call Strides Pharma Inc. weekdays from 9 AM to 5 PM EST at 1-877-244-9825

    Manufactured by:

    Strides Pharma Science Limited

    Bengaluru-562106, India.

    Distributed by:

    Strides Pharma Inc.

    East Brunswick, NJ 08816

    Issued: 06/2020

    †All trademarks are property of their respective owners. This product is not affiliated with the makers/owners of Imodium® A-D

    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.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    †COMPARE TO THE ACTIVE INGREDIENT IN IMODIUM ® A-D

    NDC 59556-959-06

    Loperamide Hydrochloride Capsules USP, 2 mg

    Anti-Diarrheal

    Suitable for adults and children 12 years and over

    12 Softgels*

    *each Liquid-filled capsule contains 2 mg Loperamide Hydrochloride, USP

    Carton Label
  • INGREDIENTS AND APPEARANCE
    LOPERAMIDE HYDROCHLORIDE 
    loperamide hydrochloride capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59556-959
    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 CAPRYLATE/CAPRATE (UNII: G7515SW10N)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    SHELLAC (UNII: 46N107B71O)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorBLUEScoreno score
    ShapeOVALSize10mm
    FlavorImprint Code L2
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59556-959-061 in 1 CARTON10/22/2021
    1NDC:59556-959-0312 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:59556-959-052 in 1 CARTON10/22/2021
    2NDC:59556-959-0312 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21307010/22/2021
    Labeler - Strides Pharma Inc (078868278)
    Establishment
    NameAddressID/FEIBusiness Operations
    Strides Pharma Science Limited918513263ANALYSIS(59556-959) , MANUFACTURE(59556-959) , PACK(59556-959)
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