Label: ANTI DIARRHEAL- loperamide hydrochloride tablet, film coated

  • NDC Code(s): 0904-7725-12, 0904-7725-24
  • Packager: Major Pharmaceuticals
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated November 10, 2022

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  • Active ingredient (in each caplet)

    Loperamide HCl 2 mg

  • Purpose

    Anti-diarrheal

  • Use

    controls symptoms of diarrhea, including Travelers’ Diarrhea

  • Warnings

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

    Heart alert: Taking more than directed can cause serious heart problems or death

    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
    •
    a history of abnormal heart rhythm

    Ask a doctor or pharmacist before use if you are

    taking a prescription drug. Loperamide may interact with certain prescription drugs.

    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).

  • 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 2-5 years

    (34 to 47 lbs)

    ask a doctor

    children under 2 years

    (up to 33 lbs)

    do not use
  • Other information

    •
    store at 20°-25°C (68°-77°F)
    •
    see end panel for lot number and expiration date
  • 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

  • Questions or comments?

    1-800-719-9260

  • Principal Display Panel

    See New Warnings

    Anti-Diarrheal

    Loperamide Hydrochloride Tablets, 2 mg

    Anti-Diarrheal Controls the Symptoms of Diarrhea

    Actual Size

    12 CAPLETS*

    *Capsule-Shaped Tablets

    COMPARE TO active ingredient of IMODIUM® A-D

    anti diarrheal image
  • INGREDIENTS AND APPEARANCE
    ANTI DIARRHEAL 
    loperamide hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-7725
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LOPERAMIDE HYDROCHLORIDE (UNII: 77TI35393C) (LOPERAMIDE - UNII:6X9OC3H4II) LOPERAMIDE HYDROCHLORIDE2 mg
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    Product Characteristics
    ColorGREENScore2 pieces
    ShapeOVALSize10mm
    FlavorImprint Code L2
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0904-7725-1212 in 1 CARTON02/24/2003
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:0904-7725-2424 in 1 CARTON02/24/2003
    21 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07523202/24/2003
    Labeler - Major Pharmaceuticals (191427277)
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