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

  • NDC Code(s): 49035-520-02, 49035-520-12, 49035-520-48
  • Packager: EQUATE (Wal-Mart Stores, Inc.)
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated October 20, 2021

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  • Active ingredient (in each capsule)

    Loperamide HCI 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 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 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 of age 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, edible ink, FD&C Blue #1 , gelatin, glycerin, glyceryl caprylate, polyoxyl 40 hydrogenated castor oil, purified water

  • Questions or comments?

    Call 1-888-287-1915
  • Principal Display Panel

    Compare to Imodium® A-D* Active Ingredient*

    Loperamide HCl

    Soft Gelatin Capsules, 2 mg

    Anti-Diarrheal

    • Controls the Symptoms of Diarrhea
    • Suitable for adults and children 12 years and older

    SOFTGELS**

    **Each Liquid-filled capsule contains 2 mg Loperamide HCl

    Distributed by: Wal-Mart Stores, Inc., Bentonville, AR  72716

    *This product is not manufactured or distributed by McNeil Consumer & Specialty Pharmaceuticals, distributor 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.

  • Product Label

    Loperamide HCI 2 mg

    EQUATE Anti-Diarrheal

  • INGREDIENTS AND APPEARANCE
    ANTI-DIARRHEAL  LOPERAMIDE HCL
    loperamide hydrochloride capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-520
    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:49035-520-121 in 1 CARTON01/15/201301/05/2024
    112 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:49035-520-484 in 1 CARTON01/15/201301/05/2024
    212 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:49035-520-02120 in 1 CARTON01/15/201301/05/2024
    31 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02185501/15/201301/05/2024
    Labeler - EQUATE (Wal-Mart Stores, Inc.) (051957769)
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