Label: 7 SELECT ANTI DIARRHEAL- loperamide hcl solution

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

Drug Label Information

Updated September 10, 2019

If you are a consumer or patient please visit this version.

  • Active ingredient (in each 7.5 mL)

    Loperamide HCl 1 mg

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  • Purpose

    Anti-diarrheal

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  • Use

    controls symptoms of diarrhea, including Travelers’ Diarrhea

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  • 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

    Ask a doctor before use if you have

    fever
    mucus in the stool
    a history of liver disease

    Ask a doctor or pharmacist before use if you are

    taking antibiotics

    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.

    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)

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  • Directions

    drink plenty of clear fluids to help prevent dehydration caused by diarrhea
    find right dose on chart. If possible, use weight to dose; otherwise use age.
    shake well before using
    use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.
    mL = milliliter

    adults and children

    12 years and over

    30 mL after the first loose stool; 15 mL after each subsequent loose stool; but no more than 60 mL in 24 hours

    children 9-11 years

    (60-95 lbs)

    15 mL after the first loose stool; 7.5 mL after each subsequent loose stool; but no more than 45 mL in 24 hours

    children 6-8 years

    (48-59 lbs)

    15 mL after the first loose stool; 7.5 mL after each subsequent loose stool; but no more than 30 mL 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

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  • Other information

    each 30 mL contains: sodium 15 mg
    store between 20-25 °C (68-77 °F)
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  • Inactive ingredients

    anhydrous citric acid, carboxymethylcellulose sodium, D&C yellow no. 10, FD&C blue no. 1, glycerin, microcrystalline cellulose, natural and artificial mint flavor, propylene glycol, purified water, simethicone, sodium benzoate, sucralose, titanium dioxide, xanthan gum

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  • Questions or comments?

    1-800-719-9260

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  • Package/Label Principal Display Panel

    Compare to Imodium® A-D active ingredient

    QUALITY GUARANTEED

    See New Warning and Directions

    Loperamide Hydrochloride Oral Solution, 1 mg per 7.5 mL

    Anti-Diarrheal

    Controls the Symptoms of Diarrhea

    Anti-Diarrheal

    Oral Solution

    Mint Flavor

    4 fl oz 120 mL

    anti-diarrheal-image
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  • INGREDIENTS AND APPEARANCE
    7 SELECT ANTI DIARRHEAL 
    loperamide hcl solution
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:10202-645
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    LOPERAMIDE HYDROCHLORIDE (UNII: 77TI35393C) (LOPERAMIDE - UNII:6X9OC3H4II) LOPERAMIDE HYDROCHLORIDE 1 mg  in 7.5 mL
    Inactive Ingredients
    Ingredient Name Strength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    Color GREEN (opaque, viscous) Score     
    Shape Size
    Flavor MINT Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:10202-645-26 120 mL in 1 BOTTLE; Type 0: Not a Combination Product 08/07/2018 04/30/2021
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA091292 08/07/2018 04/30/2021
    Labeler - 7-Eleven (007347602)
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