Label: ANTI-DIARRHEAL/ANTI-GAS CAPLETS- loperamide hydrochloride 2mg, simethicone 125mg tablet

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

Drug Label Information

Updated July 24, 2025

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  • 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 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 have difficulty swallowing the caplet
    • 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
    • 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 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; ½ 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; ½ caplet after each subsequent loose stool; but no more than 2 caplets in 24 hours
      children 2-5 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 155 mg, sodium 3 mg
    • store at 20-25°C (68-77°F)
    • protect from light
  • Inactive ingredients

    acesulfame potassium, anhydrous dicalcium phosphate, colloidal silicon dioxide, croscarmellose sodium, microcrystalline cellulose, stearic acid, vanilla flavor

  • Questions?

    call toll-free 1-866-933-6337

  • Principal Display Panel

    label

  • INGREDIENTS AND APPEARANCE
    ANTI-DIARRHEAL/ANTI-GAS CAPLETS 
    loperamide hydrochloride 2mg, simethicone 125mg tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73581-178
    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)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    Colorwhite (off-white) Score2 pieces
    ShapeCAPSULESize17mm
    FlavorImprint Code L;II
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73581-178-244 in 1 CARTON07/24/2025
    16 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21348409/10/2021
    Labeler - YYBA CORP (006339772)
    Registrant - YYBA CORP (006339772)
    Establishment
    NameAddressID/FEIBusiness Operations
    OrBion Pharmaceuticals Private Limited854403569manufacture(73581-178)
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