Label: ANTI-DIARRHEAL- loperamide hcl tablet, coated

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

Drug Label Information

Updated March 19, 2026

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  • Active ingredient(s)

    Loperamide HCl 2mg

  • Purpose

    Anti-diarrheal

  • Use(s)

    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.

    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

    • fever  
    • mucus in the stool  
    • a history of liver disease

    Ask a doctor or pharmacist before use if

    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 breastfeeding,

    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 (1-800-222-1222) right away.

  • Directions

    • drink plenty of clear fluids to help prevent dehydration caused by diarrhea
    • find right dose 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; 1/2; 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; 1/2; 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

    • store at 20º-25ºC (68º-77º F)
    • avoid excessive heat above 40ºC (104ºF)

  • Inactive ingredients

    corn starch, D&C yellow #10 aluminum lake, dicalcium phosphate dihydrate, FD&C blue #1
    brilliant blue lake, magnesium stearate, microcrystalline cellulose, silica gel

  • Questions/Comments

    Call 1-877-290-4008

  • Principal Display Panel

    Blister Carton

    Blister Carton

  • INGREDIENTS AND APPEARANCE
    ANTI-DIARRHEAL 
    loperamide hcl tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:85828-248
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LOPERAMIDE HYDROCHLORIDE (UNII: 77TI35393C) (LOPERAMIDE - UNII:6X9OC3H4II) LOPERAMIDE HYDROCHLORIDE2 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6)  
    DICALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    BRILLIANT BLUE G (UNII: M1ZRX790SI)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    Product Characteristics
    Colorgreen (Light) Score2 pieces
    ShapeCAPSULESize10mm
    FlavorImprint Code 44;375
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:85828-248-932 in 1 CARTON03/19/2026
    112 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07649703/19/2026
    Labeler - Grocery Outlet (029161585)
    Establishment
    NameAddressID/FEIBusiness Operations
    Allegiant Health079501930label(85828-248) , pack(85828-248)
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