Label: ANTI-DIARRHEAL- loperamide hydrochloride capsule 

  • Label RSS
  • 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

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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

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  • Purpose

    Antidiarrheal

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  • Use

    controls symptoms of diarrhea, including Travelers' Diarrhea

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  • 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.

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  • 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
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  • 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
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  • 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

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  • Questions or comments?

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

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  • 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


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  • INGREDIENTS AND APPEARANCE
    ANTI-DIARRHEAL 
    loperamide hcl capsule
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:64092-105
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE) LOPERAMIDE HYDROCHLORIDE 2 mg
    Inactive Ingredients
    Ingredient Name Strength
    MAGNESIUM STEARATE  
    CELLULOSE, MICROCRYSTALLINE  
    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)
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