Label: LIL DRUG STORE ANTI-DIARRHEAL- loperamide hydrochloride tablet

  • NDC Code(s): 66715-9859-2, 66715-9859-5, 66715-9859-6, 66715-9859-7
  • Packager: Lil' Drug Store Products, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated November 27, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each caplet)

    Loperamide HCl, USP 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 over2 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 - 47 lbs)     		ask a doctor
    children under 2
    (up to 33 lbs)     		do not use
  • 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 toll-free 1-877-507-6516 (M-F 8AM - 4:30PM CST)

  • PRINCIPAL DISPLAY PANEL - 2 mg Caplet Pouch Carton

    QUALITY
    ⋆ GUARANTEED ⋆

    Compare to the Active
    Ingredient in Imodium® A-D*

    Anti-
    Diarrheal

    on
    the
    Go
    PACKS

    See New Warning & Directions

    Anti-Diarrheal

    Loperamide HCl Tablets, USP 2 mg

    • Controls the Symptoms of Diarrhea

    4
    Caplets**
    2 POUCHES, 2 CAPLETS PER POUCH

    Lil'
    Drug Store ®

    PRINCIPAL DISPLAY PANEL - 2 mg Caplet Pouch Carton
  • Anti-Diarrheal Dispens-It, 25pc, Lil' Drug Store ®

    COMPARE TO THE ACTIVE INGREDIENT IN

    Imodium ® A-D*

    Anti-Diarrheal

    Loperamide HCl Tablets, USP 2 mg

    • Controls the Symptoms

    of Diarrhea

    [tablet image]

    Actual Size

    This product not for households

    with small children.

    1 CAPLET PER POUCH

    [Lil' Drug Store ® logo]

    PDP/Package

  • Anti-Diarrheal Dispens-It, 30pc, Lil' Drug Store ®

    COMPARE TO THE ACTIVE INGREDIENT IN

    Imodium ® A-D*

    Anti-Diarrheal

    Loperamide HCl Tablets, USP 2 mg

    • Controls the Symptoms

    of Diarrhea

    [tablet image]

    Actual Size

    This product not for households

    with small children.

    1 CAPLET PER POUCH

    [Lil' Drug Store ® logo]

    PDP/Package

  • INGREDIENTS AND APPEARANCE
    LIL DRUG STORE ANTI-DIARRHEAL 
    loperamide hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66715-9859
    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)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    GLYCERYL TRISTEARATE (UNII: P6OCJ2551R)  
    Product Characteristics
    ColorgreenScore2 pieces
    ShapeOVALSize10mm
    FlavorImprint Code 123
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66715-9859-21 in 1 CARTON09/01/2014
    12 in 1 POUCH; Type 0: Not a Combination Product
    2NDC:66715-9859-750 in 1 CARTON06/20/201609/12/2021
    22 in 1 POUCH; Type 0: Not a Combination Product
    3NDC:66715-9859-525 in 1 BOX, UNIT-DOSE05/06/2022
    32 in 1 POUCH; Type 0: Not a Combination Product
    4NDC:66715-9859-630 in 1 BOX, UNIT-DOSE05/06/2022
    42 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07409109/14/2012
    Labeler - Lil' Drug Store Products, Inc. (093103646)
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