Label: ANTI DIARRHEAL- loperamide hcl tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated February 21, 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 toll-free 866-933-6337

  • Principal Display Panel

    NDC 73581-171-24

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

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

    - controls symptoms of diarrhea
    - suitable for adults and children
      6 years and over

    Actual Size

    welmate™

    24 Caplets*
    *Capsule-Shaped Tablets

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

    1. To open, tear
    at perforations and
    remove a section.

    2. Use ✄ to cut
    through plastic
    for caplet.

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

    Distributed by: Wellspring Airmont, NY 10952, USA         50844    ORG061937508

    Why pay more?
    wellspringmeds.com

    Wellmate 44-375

    Wellmate 44-375

  • INGREDIENTS AND APPEARANCE
    ANTI DIARRHEAL 
    loperamide hcl tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73581-171
    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:73581-171-244 in 1 CARTON02/21/2024
    16 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07649702/21/2024
    Labeler - Yyba Corp (006339772)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837manufacture(73581-171) , pack(73581-171)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.117025878manufacture(73581-171)
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