Label: LOPERAMIDE HYDROCHLORIDE tablet

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated June 25, 2024

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

View All Sections
  • Drug Facts

    Active ingredient (in each tablet)

    Loperamide hydrochloride USP 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 hydrochloride

    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
    •
    a history of abnormal heart rhythm
  • Ask a doctor or pharmacist before use if you are

    taking a prescription drug. Loperamide may interact with certain prescription drugs.

  • 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 (1-800-222-1222) right away.

  • 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 tablets after the first loose stool; 1 tablet after each subsequent loose stool; but no more than 4 tablets in 24 hours

    children 9 to 11 years (60 to 95 lbs)

    1 tablet after the first loose stool; 1/2 tablet after each subsequent loose stool; but no more than 3 tablets in 24 hours

    children 6 to 8 years (48 to 59 lbs)

    1 tablet after the first loose stool; 1/2 tablet after each subsequent loose stool; but no more than 2 tablets in 24 hours

    children 2 to 5 years (34 to 47 lbs)

    ask a doctor

    children under 2 years (up to 33 lbs)

    do not use
  • Other information

    •
    store at 20° to 25°C (68° to 77°F).
    •
    do not use if carton or blister unit is open or torn
    •
    Meets USP dissolution test 2
    •
    See side panel for lot number and expiration date
  • Inactive ingredients

    colloidal silicon dioxide, D & C yellow No. 10 aluminum lake, FD & C blue No. 1, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate

  • Questions or comments?

    call 1-855-274-4122

    Distributed by:
    AUROHEALTH LLC
    279 Princeton-Hightstown Road
    East Windsor, NJ 08520

    Made in India

    Code .: TS/DRUGS/22/2009

    Relabeled By: Preferred Pharmaceuticals Inc.

  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 2 mg Blister Carton (4 x 6's Tablets)

    AUROHEALTH
    Relabeled By: Preferred Pharmaceuticals Inc.
    NDC 68788-8393
    *Compare to the active
    ingredient of Imodium® A-D

    Loperamide Hydrochloride
    Tablets USP 2 mg

    Anti-Diarrheal

    Controls the symptoms of diarrhea

    24 Tablets

    Loperamide HCL Tablets USP 2mg

  • INGREDIENTS AND APPEARANCE
    LOPERAMIDE HYDROCHLORIDE 
    loperamide hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68788-8393(NDC:58602-701)
    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
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    Product Characteristics
    ColorGREEN (Light Green) Score2 pieces
    ShapeCAPSULE (Biconvex) Size10mm
    FlavorImprint Code L;28
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68788-8393-24 in 1 CARTON03/01/2023
    16 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20654803/01/2023
    Labeler - Preferred Pharmaceuticals Inc. (791119022)
    Registrant - Preferred Pharmaceuticals Inc. (791119022)
    Establishment
    NameAddressID/FEIBusiness Operations
    Preferred Pharmaceuticals Inc.791119022RELABEL(68788-8393)
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

More Info on this Drug

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