Label: LOPERAMIDE HYDROCHLORIDE, SIMETHICONE tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated June 1, 2021

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  • ACTIVE INGREDIENTS (in each caplet)

    Loperamide HCl 2 mg

    Simethicone 125 mg


  • PURPOSE

    Anti-diarrheal

    Anti-gas

  • USE(S)

    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 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 180 mg, sodium 3 mg
    • store between 20-25°C (68-77°F). Protect from light
    • do not use if blister unit is torn or broken.
  • INACTIVE INGREDIENTS

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

  • QUESTIONS OR COMMENTS?

    call 1-609-860-2600 (Monday - Friday 8 am - 4 pm)

  • PRINCIPAL DISPLAY PANEL


    NDC 53041-263-50

    Multi-Symptom Relief Caplet

    Loperamide Hydrochloride and Simethicone

    Tablets, 2 mg/125 mg

    Anti-diarrheal/Anti-gas

    Relieves symptoms of diarrhea plus

    Cramps & Pressure

    Bloating

    Gas


    6 Caplets**

    **capsule-shaped tablets
    79

  • INGREDIENTS AND APPEARANCE
    LOPERAMIDE HYDROCHLORIDE, SIMETHICONE 
    loperamide hydrochloride, simethicone tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53041-263
    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)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorWHITEScore2 pieces
    ShapeCAPSULESize16mm
    FlavorCARAMEL (caramel vanilla) Imprint Code 2;63
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53041-263-501 in 1 CARTON06/01/2021
    16 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21454106/01/2021
    Labeler - Guardian Drug Company (119210276)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guardian Drug Company119210276MANUFACTURE(53041-263)
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