Label: ANTI-DIARRHEAL- loperamide hcl tablet, coated

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated September 19, 2019

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  • Active Ingredient (in each caplet)

    Loperamide HCl 2mg

  • 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 reactions 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,

    If pregnant or breast feeding, ask a health professional before use.

    Keep out of reach of children

    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.
    • 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

    • store at 20º-25ºC (68º-77º F)
    • avoid excessive heat above 40ºC (104ºF)
    • do not use if blister unit is broken or torn
  • 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

    1-800-327-2704

  • Principal Display Panel

    Anti-Diarrheal

    Anti-Diarrheal

  • INGREDIENTS AND APPEARANCE
    ANTI-DIARRHEAL 
    loperamide hcl tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53117-248
    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)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    ColorgreenScore2 pieces
    ShapeCAPSULESize10mm
    FlavorImprint Code 44;375
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53117-248-862 in 1 CARTON05/03/2005
    16 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07649705/03/2005
    Labeler - First Aid Direct (962283128)