Label: ANTI-DIARRHEAL- loperamide hcl tablet

  • NDC Code(s): 64092-105-12
  • Packager: GREAT LAKES WHOLESALE, MARKETING, & SALES, INC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated September 23, 2023

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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 (1-800-222-1222) 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

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

    HEALTHCARE™

    NDC 64092-105-12

    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

    *This product is not manufactured or distributed by
    Johnson & Johnson Corporation, owner of the registered
    trademark Imodium® A-D.      50844    REV0619M37502

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

    HEALTHCARE GUARANTEE
    If you are not completely satisfied with this
    product, regardless of reason, return your unused
    portion to Great Lakes Wholesale for a full refund

    Distributed By: Great Lakes Wholesale & Marketing L.L.C.
    3729 Patterson Ave. S.E., Grand Rapids, MI 49512
    www.glwholesale.com

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

    HealthCare 44-375

    HealthCare 44-375

  • INGREDIENTS AND APPEARANCE
    ANTI-DIARRHEAL 
    loperamide hcl tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64092-105
    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
    ColorgreenScore2 pieces
    ShapeOVALSize10mm
    FlavorImprint Code 44;375
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64092-105-122 in 1 CARTON05/03/200510/14/2024
    16 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07649705/03/200510/14/2024
    Labeler - GREAT LAKES WHOLESALE, MARKETING, & SALES, INC. (361925498)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837manufacture(64092-105) , pack(64092-105)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.117025878manufacture(64092-105)
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