Label: ANTI-DIARRHEAL- loperamide hci tablet

  • NDC Code(s): 29485-9286-2, 29485-9286-3
  • Packager: Lil' Drug Store Products, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated July 19, 2023

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  • Drug Facts

  • Active Ingredient ( in each tablet)

    Loperamide HCl, USP 2 mg

  • Purpose

    Anti-diarrheal

  • Use

    Controls symptoms of diarrhea, including Travelers’ Diarrhea

  • Warnings

    Allergy alert

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

    Heart alert

    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 hour

    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 - 47 lbs)

    		ask a doctor

    children under 2

    (up to 33 lbs)

    		do not use

  • Other Information

    Other information

    ■ store between 68-77°F (20-25°C)

  • Inactive Ingredients


    anhydrous lactose, croscarmellose sodium, crospovidone, D&C Yellow
    no. 10 aluminum lake, FD&C Blue no. 1 aluminum lake, hydrogenated
    vegetable oil, magnesium stearate, powdered cellulose, pregelatinized
    starch

  • Questions or Comments?

    Call 1-800-351-2000 (8:30 AM - 5:00 PM CST)

  • SPL UNCLASSIFIED SECTION

    *This product is not manufactured or distributed by Johnson & Johnson Consumer Inc, McNeil Consumer Healthcare Divison, distributor of Imodium® A-D

    Distributed by: Lil’ Drug Store Products, Inc., Cedar Rapids, IA 52404

  • 2 mg Loperamide Tablet

    Compare to the active ingredient in Imodium® A-D*

    Diamode

    Anti-Diarrheal Relief

    Loperamide HCl

    Tablets, USP 2 mg

    [tablet image]

    actual size

    1 CAPLET IN EACH PACKET

    READ DRUG FACTS AND INSTRUCTIONS ON PACKET

    Anti Diarrheal Relief 1 Caplet in each pouch

  • INGREDIENTS AND APPEARANCE
    ANTI-DIARRHEAL 
    loperamide hci tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:29485-9286
    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
    POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    HYDROGENATED COTTONSEED OIL (UNII: Z82Y2C65EA)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    Product Characteristics
    ColorgreenScoreno score
    ShapeOVALSize9mm
    FlavorImprint Code 123
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:29485-9286-225 in 1 BOX07/27/2016
    11 in 1 POUCH; Type 0: Not a Combination Product
    2NDC:29485-9286-330 in 1 BOX07/27/2016
    21 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07409107/27/2016
    Labeler - Lil' Drug Store Products, Inc. (093103646)
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