Label: ANTI-DIARRHEAL- loperamide hydrochloride tablet

  • 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 September 14, 2015

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

  • Active ingredient (in each caplet)

    Loperamide HCl 2 mg

    Close
  • Purpose

    Anti-diarrheal

    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 reaction to loperamide HCl.

    Do not use

    if you have bloody or black stool.

    Ask a doctor before use if you have

    • a 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 (1-800-222-1222) right away.

    Close
  • 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.
    adults and children 12 years and over 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 the 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

    • see end flap for expiration date and lot number 
    • store between 20º-25ºC (68º-77ºF)
    • 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*

    Actual Size

    12 CAPLETS

    *This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Imodium® A-D.
    50844    REV1212H37502

    HEALTHCARE GUARANTEE
    If you are not completely satisfied with this product, regardless of reason, return your unused portion to Great Lakes Wholesale for a full refund

    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 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 tablet
    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)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    Color GREEN Score 2 pieces
    Shape OVAL Size 10mm
    Flavor Imprint Code 44;375
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:64092-105-12 2 in 1 CARTON
    1 6 in 1 BLISTER PACK; Type 0: Not a Combination Product
    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