Label: LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE tablet

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated January 27, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • 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
    • 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 ag
    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 148.40 mg, sodium 1.40 mg
    • store between 20-25°C (68-77°F). Protect from light.
    • for blister: do not use if blister unit is torn or broken
  • Inactive Ingredients

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



    Questions or comments?

    Contact 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST

    Manufactured by:

    Granules India Limited

    Hyderabad-500 081, INDIA


    MADE IN INDIA

  • PRINCIPAL DISPLAY PANEL

    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

    12 Caplets *

    *capsule-shaped tablets

    foil

    carton

  • INGREDIENTS AND APPEARANCE
    LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 
    loperamide hydrochloride and simethicone tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62207-739
    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
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    Colorwhite (off white) Score2 pieces
    ShapeCAPSULE (Capsule shaped tablet) Size17mm
    FlavorVANILLAImprint Code I;9
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62207-739-692 in 1 CARTON03/01/2023
    16 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21598103/01/2023
    Labeler - Granules India Ltd (915000087)
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