Label: FIRST AID DIRECT ANTI-DIARRHEAL capsule

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

Drug Label Information

Updated December 28, 2023

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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 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).

  • 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; 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 (34-47 lbs) ask a doctor 
    children under 2 years (up to 33 lbs)do not use 

  • Other information

    • store at 20°-25°C (68°-77°F)
    • avoid excessive heat above 40°C (104°F)
    • do not use 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

    Loperamide Hydrochloride Tablets, 2 mg

    Anti-Diarrheal

    Controls the Symptoms of Diarrhea

    *Compare to active ingredient of Imodium A-D®
    DO NOT USE IF BLISTER UNIT IS BROKEN OR TORN

    Actual size

    12 CAPLETS** Anti-Diarrheal

    **Capsule-Shaped Tablet

    Box

  • INGREDIENTS AND APPEARANCE
    FIRST AID DIRECT ANTI-DIARRHEAL 
    first aid direct anti-diarrheal capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42961-103
    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)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    ColorgreenScore2 pieces
    ShapecapsuleSize10mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42961-103-022 in 1 BOX10/20/2021
    16 in 1 BLISTER PACK; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07649710/20/2021
    Labeler - Cintas Corp (056481716)
    Establishment
    NameAddressID/FEIBusiness Operations
    Allegiant Health079501930manufacture(42961-103)
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