Label: LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE- loperamide hydrochloride, simethicone tablet

  • NDC Code(s): 69842-807-53, 69842-807-65
  • Packager: CVS Pharmacy
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated December 15, 2022

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  • Active ingredients (in each caplet)

    Loperamide HCl 2 mg

    Simethicone 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
  • 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 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 9-11 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 printed blister unit is broken or torn
  • Inactive ingredients

    acesulfame potassium, croscarmellose sodium, dibasic calcium phosphate, maltodextrin, microcrystalline cellulose, natural and artificial flavor, propylene glycol, stearic acid

  • Questions or comments?

    1-800-719-9260

  • Package/Label Principal Display Panel

    Compare to the active ingredients in Imodium® Multi-Symptom Relief

    Loperamide Hydrochloride and Simethicone Tablets, 2 mg/125 mg

    ANTI-DIARRHEAL / ANTI-GAS

    Multi-symptom relief caplet

    Relieves symptoms of diarrhea plus:

    Cramps & Pressure

    Bloating

    Gas

    See New Warning and Directions

    12 CAPLETS*

    *Capsule-shaped tablets

    Actual Size

    loperamide and simethicone tablets image
  • INGREDIENTS AND APPEARANCE
    LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 
    loperamide hydrochloride, simethicone tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-807
    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
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorWHITEScore2 pieces
    ShapeOVALSize17mm
    FlavorImprint Code L0R1;2;125
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-807-5312 in 1 CARTON10/08/2018
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:69842-807-651 in 1 CARTON10/16/201807/31/2021
    230 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20983710/08/2018
    Labeler - CVS Pharmacy (062312574)
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