Label: ANTI DIARRHEAL- loperamide hydrochloride tablet, film coated 

  • NDC Code(s): 30142-998-23, 30142-998-53, 30142-998-62, 30142-998-67
  • Packager: Kroger Company
  • 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 03/14

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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  • Uses

    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 reaction to loperamide HCl

    Do not use

    if you have bloody or black stool

    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 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 right away. (1-800-222-1222)

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  • 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

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  • Other information

    store at 20°-25°C (68°-77°F)
    do not use if blister unit is broken or torn {For use on Blister Cartons Only}
    do not use if printed foil under cap is broken or missing {For use on Bottle Cartons Only}
    see end panel for lot number and expiration date {For use on Bottle Cartons Only}
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  • Inactive ingredients

    anhydrous lactose, carnauba wax, D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch

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  • Questions or comments?

    1-800-632-6900

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  • Principal Display Panel

    COMPARE TO the active ingredient of IMODIUM® A-D

    See top panel

    Loperamide Hydrochloride Tablets, 2 mg

    Anti-Diarrheal

    CONTROLS THE SYMPTOMS OF DIARRHEA

    72 CAPLETS*

    *each caplet (capsule-shaped tablet) contains 2 mg Loperamide Hydrochloride

    actual size

    Anti-Diarrheal Image 1
    Anti-Diarrheal Image 2
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  • INGREDIENTS AND APPEARANCE
    ANTI DIARRHEAL 
    loperamide hydrochloride tablet, film coated
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:30142-998
    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
    ANHYDROUS LACTOSE  
    CARNAUBA WAX  
    HYPROMELLOSES  
    MAGNESIUM STEARATE  
    CELLULOSE, MICROCRYSTALLINE  
    POLYETHYLENE GLYCOLS  
    Product Characteristics
    Color GREEN Score 2 pieces
    Shape CAPSULE Size 10mm
    Flavor Imprint Code L2
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:30142-998-53 12 in 1 CARTON
    1 1 in 1 BLISTER PACK
    2 NDC:30142-998-62 24 in 1 CARTON
    2 1 in 1 BLISTER PACK
    3 NDC:30142-998-67 1 in 1 CARTON
    3 48 in 1 BOTTLE
    4 NDC:30142-998-23 1 in 1 CARTON
    4 72 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA075232 02/21/2003
    Labeler - Kroger Company (006999528)
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