Label: ANTI DIARRHEAL ANTI GAS- loperamide hydrochloride, simethicone tablet

  • NDC Code(s): 30142-581-53, 30142-581-62
  • Packager: Kroger Company
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated February 7, 2020

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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 foil under cap 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?

    1-800-632-6900

  • Package/Label Principal Display Panel

    COMPARE TO the active ingredients of IMODIUM® MULTI-SYMPTOM RELIEF

    See side panel

    SEE NEW WARNING AND DIRECTIONS

    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

    Our Pharmacists Recommend

    12 CAPLETS*

    *Capsule-Shaped Tablets

    actual size

    anti-diarrheal-anti-gas.jpg
  • INGREDIENTS AND APPEARANCE
    ANTI DIARRHEAL ANTI GAS 
    loperamide hydrochloride, simethicone tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30142-581
    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:30142-581-5312 in 1 CARTON04/24/2019
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:30142-581-6224 in 1 CARTON02/07/2020
    21 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20983704/24/2019
    Labeler - Kroger Company (006999528)
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