Label: IMODIUM MULTI-SYMPTOM RELIEF- loperamide hydrochloride and dimethicone tablet

  • NDC Code(s): 50580-338-06, 50580-338-12, 50580-338-18, 50580-338-30, view more
    50580-338-42, 50580-338-60, 50580-338-61, 50580-338-64
  • Packager: Kenvue Brands LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated December 12, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each caplet)Purposes
    Loperamide HCl 2 mgAnti-diarrheal
    Simethicone 125 mgAnti-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 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 165 mg, sodium 3 mg
    • store between 20-25°C (68-77°F). Protect from light.
    • do not use if blister unit is torn or broken
  • Inactive ingredients

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

  • Questions or comments?

    call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)

  • PRINCIPAL DISPLAY PANEL

    NDC 50580-338-12

    Imodium ®

    Loperamide HCl, 2 mg /Simethicone, 125 mg Antidiarrheal/Anti-gas

    Multi-Symptom Relief

    Caplet

    Relieves symptoms
    of diarrhea plus

    • Cramps & Pressure
    • Bloating
    • Gas

    12 Caplets*

    *capsule-shaped tablets

    Actual Size

    imodium-1

  • INGREDIENTS AND APPEARANCE
    IMODIUM  MULTI-SYMPTOM RELIEF
    loperamide hydrochloride and dimethicone tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50580-338
    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
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorwhiteScore2 pieces
    ShapeOVALSize16mm
    FlavorImprint Code IMO;2;125
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50580-338-122 in 1 CARTON07/01/2008
    16 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:50580-338-183 in 1 CARTON07/01/2008
    26 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:50580-338-421 in 1 CARTON07/01/200809/07/2021
    342 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:50580-338-301 in 1 CARTON07/01/200809/07/2021
    430 in 1 BOTTLE; Type 0: Not a Combination Product
    5NDC:50580-338-602 in 1 PACKAGE06/14/201307/31/2021
    51 in 1 CARTON
    530 in 1 BOTTLE; Type 0: Not a Combination Product
    6NDC:50580-338-614 in 1 CARTON06/24/2019
    66 in 1 BLISTER PACK; Type 0: Not a Combination Product
    7NDC:50580-338-644 in 1 CARTON02/26/2024
    76 in 1 BLISTER PACK; Type 0: Not a Combination Product
    8NDC:50580-338-061 in 1 CARTON03/31/2025
    86 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02114007/01/2008
    Labeler - Kenvue Brands LLC (118772437)
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