Label: INTESTINOMICINA- loperamide hci, simethicone capsule

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated January 24, 2024

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  • Drug Facts

  • Active ingredients (in each caplet) & Purposes

    .

    Active ingredients (in each caplet)Purposes
    Loperamide HCI 2 mg .............Anti-diarrheal
    Simethicone 125 mg ...............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 abdominal heart rythm

    Ask a doctor or pharmacist before use if you are

    • taking a prescription drug. Loperamide interact with certain prescriptions 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 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 printed blister unit is broken or torn
  • Inactive ingredients

    acesulfame potassium, colloidol silicone dioxide, croscarmellose sodium, dibasic calcium phosphate, flavor, microcrystalline cellulose, stearic acid

  • Questions or comments?

    call 1-754-260-6474 (Monday - Friday 8 am - 4 pm)

  • Package/Label Principal Display Panel

    Intestinomicina ADplus_PDPi

  • INGREDIENTS AND APPEARANCE
    INTESTINOMICINA 
    loperamide hci, simethicone capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76864-100
    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)  
    CELLULOSE, MICROCRYSTALLINE (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:76864-100-1212 in 1 CARTON07/08/202211/30/2024
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21454107/04/201811/30/2024
    Labeler - Procaps S.A. de C.V. (851259341)
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