Label: LOPERAMIDE HCL AND SIMETHICONE tablet

  • NDC Code(s): 51660-069-06, 51660-069-12, 51660-069-18, 51660-069-24
  • Packager: Ohm Laboratories Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated August 30, 2022

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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 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 (1800-222-1222).

  • 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; 1/2 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; 1/2 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 (upto 33 lbs)

    do not use

    Other information

    •
    calcium: contains 142 mg/caplet
    •
    store between 20-25° C (68-77° F). Protect from light.
    •
    TAMPER EVIDENT: THIS PRODUCT PROTECTED WITH SEALED BLISTER UNITS. DO NOT USE IF ANY ARE TORN OR BROKEN.
  • Inactive ingredients

    calcium silicate, colloidal silicon dioxide, dibasic calcium phosphate, microcrystalline cellulose, sodium starch glycolate, stearic acid

  • Questions?

    call 1-800-406-7984

  • SPL UNCLASSIFIED SECTION

    Manufactured by:
    Sun Pharmaceutical
    Industries Limited,
    MOHALI, INDIA

    Distributed by:
    Ohm Laboratories Inc.,
    New Brunswick,
    NJ 08901

  • PRINCIPAL DISPLAY PANEL - 6 Capsule Blister Pack Carton

    †Compare To
    the active ingredients of
    Imodium®
    Multi-Symptom Relief

    NDC 51660-069-06

    ohm®

    Loperamide HCl and
    Simethicone Tablets,
    2 mg/125 mg

    Anti-Diarrheal/Anti-Gas
    Multi-Symptom Relief

    Relieves symptoms of diarrhea plus

    • Cramps & Pressure
    • Bloating
    • Gas

    6 CAPLETS*
    (*capsule-shaped tablets)

    PRINCIPAL DISPLAY PANEL - 6 Capsule Blister Pack Carton
  • PRINCIPAL DISPLAY PANEL - 12 Caplet Blister Pack Carton

    †Compare To
    the active ingredients of
    Imodium®
    Multi-Symptom Relief

    NDC 51660-069-12

    ohm®

    Loperamide HCl and
    Simethicone Tablets,
    2 mg/125 mg

    Anti-Diarrheal/Anti-Gas
    Multi-Symptom Relief

    Relieves symptoms of diarrhea plus

    • Cramps & Pressure
    • Bloating
    • Gas

    12 CAPLETS*
    (*capsule-shaped tablets)

    PRINCIPAL DISPLAY PANEL - 12 Caplet Blister Pack Carton
  • PRINCIPAL DISPLAY PANEL - 18 Caplet Blister Pack Carton

    †Compare To
    the active ingredients of
    Imodium®
    Multi-Symptom Relief

    NDC 51660-069-18

    ohm®

    Loperamide HCl and
    Simethicone Tablets,
    2 mg/125 mg

    Anti-Diarrheal/Anti-Gas
    Multi-Symptom Relief

    Relieves symptoms of diarrhea plus

    • Cramps & Pressure
    • Bloating
    • Gas

    18 CAPLETS*
    (*capsule-shaped tablets)

    PRINCIPAL DISPLAY PANEL - 18 Caplet Blister Pack Carton
  • PRINCIPAL DISPLAY PANEL - 24 Caplet Blister Pack Carton

    †Compare To
    the active ingredients of
    Imodium®
    Multi-Symptom Relief

    NDC 51660-069-24

    ohm®

    Loperamide HCl and
    Simethicone Tablets,
    2 mg/125 mg

    Anti-Diarrheal/Anti-Gas
    Multi-Symptom Relief

    Relieves symptoms of diarrhea plus

    • Cramps & Pressure
    • Bloating
    • Gas

    24 CAPLETS*
    (*capsule-shaped tablets)

    PRINCIPAL DISPLAY PANEL - 24 Caplet Blister Pack Carton
  • INGREDIENTS AND APPEARANCE
    LOPERAMIDE HCL AND SIMETHICONE 
    loperamide hcl and simethicone tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51660-069
    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
    CALCIUM SILICATE (UNII: S4255P4G5M)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    Product Characteristics
    ColorWHITE (white to off-white) Scoreno score
    ShapeCAPSULESize16mm
    FlavorImprint Code NA
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51660-069-066 in 1 BLISTER PACK; Type 0: Not a Combination Product01/13/2022
    2NDC:51660-069-122 in 1 CARTON01/13/2022
    26 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:51660-069-183 in 1 CARTON01/13/2022
    36 in 1 BLISTER PACK; Type 0: Not a Combination Product
    4NDC:51660-069-244 in 1 CARTON01/13/2022
    46 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07750001/13/2022
    Labeler - Ohm Laboratories Inc. (184769029)
    Registrant - Sun Pharmaceutical Industries, Inc. (146974886)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sun Pharmaceutical Industries Limited650456002MANUFACTURE(51660-069)
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