Label: SUNMARK LOPERAMIDE HYDROCHLORIDE- loperamide hydrochloride suspension 

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

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 02/14

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

    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
    only use attached measuring cup to dose product

    adults and children

    12 years and over

    30 mL (6 tsp) after the first loose stool; 15 mL (3 tsp) after each subsequent loose stool; but no more than 60 mL (12 tsp) in 24 hours

    children 9-11 years

    (60-95 lbs)

    15 mL (3 tsp) after the first loose stool; 7.5 mL (1 1/2 tsp) after each subsequent loose stool; but no more than 45 mL (9 tsp) in 24 hours

    children 6-8 years

    (48-59 lbs)

    15 mL (3 tsp) after the first loose stool; 7.5 mL (1 1/2 tsp) after each subsequent loose stool; but no more than 30 mL (6 tsp) in 24 hours

    children under

    6 years

    (up to 47 lbs)

    ask a doctor

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  • Other information

    each 30 mL (6 tsp) contains: sodium 15 mg
    store between 20-25°C (68-77°F)
    see side panel for lot number and expiration date
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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

    loperamide hydrochloride oral suspension

    Anti-Diarrheal

    CONTROLS THE SYMPTOMS OF DIARRHEA

    GLUTEN FREE

    MINT FLAVOR

    4 FL OZ (120 mL)

    1 mg Loperamide Hydrochloride per 7.5 mL

    Sunmark Loperamide Hydrochloride Oral Suspension Image 1
    Sunmark Loperamide Hydrochloride Oral Suspension Image 2
    Sunmark Loperamide Hydrochloride Oral Suspension Image 3
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  • INGREDIENTS AND APPEARANCE
    SUNMARK LOPERAMIDE HYDROCHLORIDE 
    loperamide hcl suspension
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:49348-999
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE) LOPERAMIDE HYDROCHLORIDE 1 mg  in 7.5 mL
    Inactive Ingredients
    Ingredient Name Strength
    ANHYDROUS CITRIC ACID  
    CARBOXYMETHYLCELLULOSE SODIUM  
    D&C YELLOW NO. 10  
    FD&C BLUE NO. 1  
    GLYCERIN  
    CELLULOSE, MICROCRYSTALLINE  
    PROPYLENE GLYCOL  
    WATER  
    SODIUM BENZOATE  
    SUCRALOSE  
    TITANIUM DIOXIDE  
    XANTHAN GUM  
    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:49348-999-34 120 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA091292 02/18/2014
    Labeler - McKesson (177667227)
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