Label: HARMON FACE VALUES ANTI DIARRHEAL- loperamide hcl tablet, film coated

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

Drug Label Information

Updated December 12, 2019

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

View All Sections
  • Active ingredient (in each caplet)

    Loperamide HCl 2 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.

    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 under 6 years

    (up to 47 lbs)

    ask a doctor
  • Other information

    •
    store at 20°-25°C (68°-77°F)
    •
    do not use if blister unit is broken or torn
  • Inactive ingredients

    anhydrous lactose, carnauba wax, D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch

  • Questions or comments?

    1-800-719-9260

  • Principal Display Panel

    Compare Ours to the Active Ingredient in Imodium® A-D

    Loperamide Hydrochloride Tablets, 2mg

    Anti-Diarrheal

    Controls the symptoms of diarrhea

    ACTUAL SIZE

    Easy to Swallow

    12 Caplets*

    *Each caplet (capsule-shaped tablet) contains 2 mg loperamide hydrochloride

    Anti-Diarrheal Carton Image 1
    Anti-Diarrheal Carton Image 2
  • INGREDIENTS AND APPEARANCE
    HARMON FACE VALUES ANTI DIARRHEAL 
    loperamide hcl tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63940-224
    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
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    Product Characteristics
    ColorGREENScore2 pieces
    ShapeCAPSULESize10mm
    FlavorImprint Code L2
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63940-224-5312 in 1 CARTON12/18/2011
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07523212/18/2011
    Labeler - Harmon Stores Inc. (804085293)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!