Label: LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE tablet

  • NDC Code(s): 69452-210-04, 69452-210-12
  • Packager: Bionpharma Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated October 19, 2021

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • 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. (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 years to 11 years

    (60 lbs to 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 years to 8 years

    (48 lbs to 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 years to 5 years

    (34 lbsto 47 lbs)     		ask a doctor
    children under 2 years

    (up to 33 lbs)     		do not use

  • Other information

    • each caplet contains: calcium 155 mg, sodium 3 mg
    • store between 20° to 25°C (68° to 77°F). Protect from light.
  • Inactive ingredients

    acesulfame potassium, anhydrous dicalcium phosphate, colloidal silicon dioxide, croscarmellose sodium, microcrystalline cellulose, stearic acid, vanilla flavor

  • Questions or comments?

    call toll-free 1-888-235-2466

    ***All trademarks are property of their respective owners. This product is not affiliated with the makers/owners of Imodium ® Multi-Symptom Relief

    THIS PRODUCT IS PACKAGED IN A CHILD-RESISTANT AND TAMPER EVIDENT PACKAGE. USE ONLY IF BLISTERS ARE INTACT.

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

    Manufactured for:

    BIONPHARMA

    600 Alexander Road,

    Princeton, NJ 08540

    MADE IN INDIA

    Rev # 09/19

    L0000000

  • PRINCIPAL DISPLAY PANEL

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

    NDC 69452-210-04

    Loperamide HCl
    and Simethicone Tablets,
    2 mg/125 mg

    Antidiarrheal/Anti-gas

    Multi-Symptom Relief

    Caplet

    Relieves symptoms of diarrhea plus

    • Cramps & Pressure
    • Bloating
    • Gas

    Actual Size

    6 Caplets*

    *Capsule-shaped Tablets

    6 Caplets - Carton

  • INGREDIENTS AND APPEARANCE
    LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 
    loperamide hydrochloride and simethicone tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69452-210
    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
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    VANILLA (UNII: Q74T35078H)  
    Product Characteristics
    Colorwhite (off-white) Score2 pieces
    ShapeCAPSULESize17mm
    FlavorImprint Code LS1
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69452-210-041 in 1 CARTON12/19/2021
    16 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:69452-210-124 in 1 CARTON12/19/2021
    26 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21348412/01/2021
    Labeler - Bionpharma Inc. (079637826)
    Registrant - Bionpharma Inc. (079637826)
    Establishment
    NameAddressID/FEIBusiness Operations
    Recipharm Pharmaservices Pvt. Ltd.871401927manufacture(69452-210)
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