Label: HEALTH MART LOPERAMIDE HYDROCHLORIDE- loperamide hydrochloride suspension

  • NDC Code(s): 62011-0236-1
  • Packager: Strategic Sourcing Services LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated August 29, 2019

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

  • Active ingredient (in each 7.5 mL)

    Loperamide HCl 1 mg

  • Purpose

    Anti-diarrheal

  • Use

    controls symptoms of diarrhea, including Travelers’ Diarrhea

  • 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)

  • 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 ½ 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 ½ 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

  • 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
  • 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

  • Questions or comments?

    1-800-719-9260

  • Package/Label Principal Display Panel

    compare to Imodium® A-D active ingredient

    for ages 6 years and up

    loperamide hydrochloride oral suspension

    anti-diarrheal liquid

    controls the symptoms of diarrhea

    mint flavor

    1 mg loperamide hydrochloride per 7.5 mL

    4 fl oz (120 mL)

    Health Mart Loperamide Hydrochloride Oral Suspension Image 1
    Health Mart Loperamide Hydrochloride Oral Suspension Image 2
  • INGREDIENTS AND APPEARANCE
    HEALTH MART LOPERAMIDE HYDROCHLORIDE 
    loperamide hydrochloride suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62011-0236
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LOPERAMIDE HYDROCHLORIDE (UNII: 77TI35393C) (LOPERAMIDE - UNII:6X9OC3H4II) LOPERAMIDE HYDROCHLORIDE1 mg  in 7.5 mL
    Inactive Ingredients
    Ingredient NameStrength
    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)  
    Product Characteristics
    ColorGREENScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62011-0236-1120 mL in 1 BOTTLE; Type 0: Not a Combination Product06/11/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09129206/11/2014
    Labeler - Strategic Sourcing Services LLC (116956644)