Label: ANTI DIARRHEAL- loperamide hydrochloride tablet 

  • Label RSS
  • 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 10/13

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

    Anti-diarrheal

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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 (1-800-222-1222) 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

    • do not use if carton or safety seal is broken or missing
    • store between 20º-25ºC (68º-77ºF)
    • see end flap for expiration date and lot number
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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

    NDC 68196-375-04

    SIMPLY RIGHT
    Health Care

    Loperamide Hydrochloride caplets, 2 mg
    anti-diarrheal

    Compare to Imodium A-D® active ingredient*

    controls the symptoms of diarrhea
    easy to swallow, small caplets

    Each caplet (capsule-shaped tablets) contains2 mg Loperamide Hydrochloride

    350 caplets

    *This product is not manufactured or distributed by McNeil consumer Healthcare, owner of the registered trademark Imdium A-D®.
    50844        REV1212A37504

    Distributed by:
    SAM'S West, Inc.
    Bentonville, AR 72716

    TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

    Simply Right 44-375

    Simply Right 44-375

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  • INGREDIENTS AND APPEARANCE
    ANTI DIARRHEAL 
    loperamide hcl tablet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:68196-375
    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  
    D&C YELLOW NO. 10  
    FD&C BLUE NO. 1  
    Product Characteristics
    Color BLUE Score no score
    Shape CAPSULE Size 10mm
    Flavor Imprint Code 44;375
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:68196-375-04 1 in 1 CARTON
    1 350 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA076497 05/03/2005
    Labeler - Sam's West Inc (051957769)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 038154464 PACK(68196-375)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 832867894 MANUFACTURE(68196-375)
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