Label: LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE tablet

  • NDC Code(s): 0363-9606-75, 0363-9606-76
  • Packager: WALGREEN CO.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated December 2, 2023

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  • Drug Facts

    Active ingredients (in each caplet) 

    Loperamide HCl USP 2 mg
    Simethicone USP 125 mg

  • Purposes

    Anti-diarrheal
    Anti-gas

  • Uses

    relieves symptoms of diarrhea plus bloating, pressure and cramps, commonly referred to as gas

  • 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
    • if you have difficulty swallowing
  • 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.
    • you have difficulty swallowing the caplet
  • 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
    • take only on an empty stomach (1 hour before or 2 hours after a meal)
    • take with a full (8 oz.) glass of water
    • find right dose on chart below. If possible, use weight to dose; otherwise, use age.
    adults and children 12 years and over
    		2 caplets after the first loose stool; 1 caplet after each subsequent loose stool; but no more than 4 caplets in 24 hours
    children 9 to 11 years (60 to 95 lbs)
    		1 caplet after the first loose stool; ½ caplet
    after each subsequent loose stool; but no more than 3 caplets in 24 hours
    children 6 to 8 years (48 to 59 lbs)
    		1 caplet after the first loose stool; ½ caplet after each subsequent loose stool; but no more than 2 caplets in 24 hours
    children 2 to 5 years (34 to 47 lbs)
    		ask a doctor
    children under 2 years (up to 33 lbs)
    		do not use
  • Other information

    • each caplet contains: calcium 165 mg, sodium 4 mg
    • store between 20° to 25°C (68° to 77°F). Protect from light.
    • do not use if carton is opened or if individual blister units are torn or opened
  • Inactive ingredients

    acesulfame potassium, croscarmellose sodium, dibasic calcium phosphate anhydrous, flavor, microcrystalline cellulose, stearic acid.

  • Questions or comments?

    call 1-855-274-4122

    (Monday – Friday 8:30 AM to 5:00 PM EST)


    DISTRIBUTED BY:
    WALGREEN CO.
    200 WILMOT RD., DEERFIELD, IL 60015

    Walgreens
    100% SATISFACTION
    GUARANTEED

    walgreens.com
    ©2022 Walgreen Co.

    MADE IN INDIA


    Code: AP/DRUGS/04/2016

  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 2 mg/125mg (24 Caplets) Blister Carton Label

    NDC 0363-9606-76

    Walgreens
    Compare to the active ingridients in
    Imodium® Multi-Sympton Relief††


    Anti - Diarrheal +
    Anti - Gas
    LOPERAMIDE HCl & SIMETHICONE TABLETS, 2 mg/125 mg
    ANTI-DIARRHEAL / ANTI-GAS

    Multi-Symptom Relief Caplet
     •    Relieves symptoms of diarrhea plus:
                Cramps & Pressure; Bloating; Gas
    24 CAPLETS*                                       ACTUAL SIZE
    (*capsule-shaped tablets)

    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 2 mg/125mg (24 Caplets) Blister Carton Label

  • INGREDIENTS AND APPEARANCE
    LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 
    loperamide hydrochloride and simethicone tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-9606
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LOPERAMIDE HYDROCHLORIDE (UNII: 77TI35393C) (LOPERAMIDE - UNII:6X9OC3H4II) LOPERAMIDE HYDROCHLORIDE2 mg
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE125 mg
    Inactive Ingredients
    Ingredient NameStrength
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    MICROCRYSTALLINE CELLULOSE 101 (UNII: 7T9FYH5QMK)  
    MICROCRYSTALLINE CELLULOSE 102 (UNII: PNR0YF693Y)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorWHITE (off-white) Score2 pieces
    ShapeCAPSULESize17mm
    FlavorVANILLAImprint Code T;79
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-9606-752 in 1 CARTON08/03/2022
    16 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:0363-9606-764 in 1 CARTON08/03/2022
    26 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21105908/03/2022
    Labeler - WALGREEN CO. (008965063)
    Registrant - Aurohealth LLC (078728447)
    Establishment
    NameAddressID/FEIBusiness Operations
    APL HEALTHCARE LIMITED650918514ANALYSIS(0363-9606) , MANUFACTURE(0363-9606)
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