Label: ANTI DIARRHEAL- loperamide hcl tablet

  • NDC Code(s): 63868-559-12, 63868-559-24
  • Packager: CHAIN DRUG MARKETING ASSOCIATION INC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated January 19, 2024

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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

    • a 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.

  • 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 years (up to 33 lbs)do not use
  • Other information

    • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
    • store between 20°-25°C (68°-77°F)
    • see end flap for expiration date and lot number
  • Inactive ingredients

    corn starch, D&C yellow #10 aluminum lake, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, silicon dioxide

  • Questions or comments?

    Call 1-800-426-9391 8:30 AM-4:00 PM ET, Monday-Friday

  • Principal display panel

    QC®
    Quality
    Choice

    NDC 63868-559-12

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

    Anti-Diarrheal
    Loperamide HCl Tablets, 2 mg
    Anti-Diarrheal

    Controls the Symptoms of Diarrhea

    actual
    size

    12 Caplets

    TAMPER EVIDENT: DO NOT USE IF PACKAGE
    IS OPENED OR IF BLISTER UNIT IS TORN,
    BROKEN OR SHOWS ANY SIGNS OF TAMPERING

    *This product is not manufactured or distributed by
    Kenvue Inc., owner of the registered trademark IMODIUM® A-D.

    Distributed by CDMA, Inc.
    Novi, MI 48375
    www.qualitychoice.com
    Questions: 800-935-2362

    1. To open, tear           2. Use ✄ to cut
    at perforations and     through plastic
    remove a section.       for caplet.

    50844    REV0619B37502

    Quality Choice 44-375

    Quality Choice 44-375

  • INGREDIENTS AND APPEARANCE
    ANTI DIARRHEAL 
    loperamide hcl tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-559
    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
    STARCH, CORN (UNII: O8232NY3SJ)  
    D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    Colorgreen (Light) Score2 pieces
    ShapeOVALSize10mm
    FlavorImprint Code 44;375
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63868-559-244 in 1 CARTON05/03/2005
    16 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:63868-559-122 in 1 CARTON05/03/2005
    26 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07649705/03/2005
    Labeler - CHAIN DRUG MARKETING ASSOCIATION INC (011920774)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837manufacture(63868-559) , pack(63868-559)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.117025878manufacture(63868-559)
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