Label: ANTI-DIARRHEAL LOPERAMIDE HCL, 2 MG CAPLETS- loperamide hcl tablet

  • NDC Code(s): 66424-735-02, 66424-735-96
  • Packager: SDA Laboratories, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated April 29, 2021

If you are a consumer or patient please visit this version.

  • Drug Facts

  • Active ingredient (in each caplet)

    Loperamide HCl 2 mg

  • Purpose

    Anti-diarrheal

  • Use

    controls symptoms of diarrhea, including Traveler's 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

    Ask a doctor or pharmacist before use if you are taking antibiotics

    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 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 accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • Directions

    • drink plenty of clear liquids to help prevent dehydration caused by diarrhea
    • find the right dose on the 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 under 6 years (up to 47 lbs)ask a doctor

  • Other information

    • store between 20° and 25°C (68° and 77°F)
  • Inactive ingredients

    Corn starch, D&C yellow #10 aluminum lake, dicalcium phosphate dihydrate, FD&C blue #1 brilliant blue lake, magnesium stearate, microcrystalline cellulose, silica gel

  • Questions?

    call toll free 1-800-687-0176

    Mon - Fri 8 am to 4 pm

  • SPL UNCLASSIFIED SECTION

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

    ORIGINAL PRESCRIPTION STRENGTH

    CONTROLS SYMPTOMS OF DIARRHEA

    DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED

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

    L.Rev. 08/18

    Distributed by:

    SDA Laboratories, Inc.

    Greenwich, CT 06830

  • PRINCIPAL DISPLAY PANEL

    01b LBL_Anti-Diarrheal_96ct_PDP

    01b LBL_Anti-Diarrheal_200ct_PDP

    01b LBL_Anti-Diarrheal_96ct_DF1

    01b LBL_Anti-Diarrheal_96ct_DF2

  • INGREDIENTS AND APPEARANCE
    ANTI-DIARRHEAL LOPERAMIDE HCL, 2 MG CAPLETS 
    loperamide hcl tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66424-735
    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 (UNII: 35SW5USQ3G)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    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:66424-735-02200 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/01/2018
    2NDC:66424-735-9696 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/28/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07649709/01/2018
    Labeler - SDA Laboratories, Inc. (948067889)