Label: ANTI-DIARRHEAL- loperamide hydrochloride capsule

  • NDC Code(s): 64092-105-12
  • Packager: GREAT LAKES WHOLESALE, MARKETING, & SALES, INC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated 06/13

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

  • Active ingredient (in each caplet)

    Loperamide HCl 2 mg

    Close
  • Purpose

    Antidiarrheal

    Close
  • Use

    controls symptoms of diarrhea, including Travelers' Diarrhea

    Close
  • Warnings

     Allergy alert: Do not use if you have ever had a rash or other allergic reactions to loperamide HCl

    Do not use

     if you have bloody or black stool

    Ask a doctor before use if you have

    •  high 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 buldging. 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.

    Close
  • Directions

    • drink plenty of clear fluids to help prevent dehydration caused by diarrhea
    • find right dose on chat. If possible, use weight to dose; otherwise, use age.
    adults and children 12 years and older  2 caplets after the first loose stool; 1 caplet after each subsequent loose stool; but no more than 4 caplets in 24 hours
     children 9-11 years (60-95 lbs) 1 caplet after first loose stool; 1/2 caplet after each subsequent loose stool; but no more than 3 caplets in 24 hours
    children 6-8 years (48-59 lbs) 1 caplet after the first loose stool; 1/2 caplet after each subsequent loose stool; but no more than 2 caplets in 24 hours
    children under 6 years (up to 47 lbs) ask a doctor
    Close
  • Other information

    • store at controlled room temperature 20º-25ºC (68º-77ºF)
    • see end flap for expiration date and lot number
    • do not use if carton or blister unit is open or torn
    Close
  • Inactive ingredients

    corn starch, D&C yellow # 10 aluminum lake, dicalcium phosphate dihydrate, FD&C blue #1 brilliant blue lake, magnesium stearate, microcrystalline cellulose, silica gel

    Close
  • Questions or comments?

    Call 1-800-426-9391 8:30 AM-4:00 PM ET, Monday-Friday

    Close
  • Principal Display Panel

    HEALTHCARE
    NDC 64092-105-12

    Anti-Diarrheal
    Loperamide Hydrochloride Caplets, 2 mg

    Controls the Symptoms of Diarrhea

    Compare to the active ingredient in Imodium® A-D Caplets*

    12 CAPLETS

    * This product is not manufactured or distributed by Schering-Plough HealthCare Products, owner of the registered trademark Correctol®.
    50844    REV1212G37502

    Distributed by:
    Great Lakes Wholesale & Marketing L.L.C.
    3729 Patterson Ave., S.E.
    Grand Rapids, MI 49512
    www.glwholesale.com

    TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF A BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

    Healthcare 44-375

    Healthcare 44-375


    Close
  • INGREDIENTS AND APPEARANCE
    ANTI-DIARRHEAL 
    loperamide hcl capsule
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:64092-105
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    LOPERAMIDE HYDROCHLORIDE (UNII: 77TI35393C) (LOPERAMIDE - UNII:6X9OC3H4II) LOPERAMIDE HYDROCHLORIDE 2 mg
    Inactive Ingredients
    Ingredient Name Strength
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    Product Characteristics
    Color GREEN Score 2 pieces
    Shape CAPSULE Size 10mm
    Flavor Imprint Code 44;375
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:64092-105-12 1 in 1 CARTON
    1 12 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA076497 05/03/2005
    Labeler - GREAT LAKES WHOLESALE, MARKETING, & SALES, INC. (361925498)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 038154464 PACK(64092-105)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 832867894 MANUFACTURE(64092-105)
    Close