Label: LOPERAMIDE HYDROCHLORIDE tablet

  • NDC Code(s): 58602-701-01, 58602-701-02, 58602-701-76
  • Packager: Aurohealth LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated May 29, 2021

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  • 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

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

    AUROHEALTH

    NDC 58602-701-76

    *Compare to the active
    ingredient of Imodium® A-D

    Loperamide Hydrochloride
    Tablets USP 2 mg

    Anti-Diarrheal

    Controls the symptoms of diarrhea

    24 Tablets

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

  • INGREDIENTS AND APPEARANCE
    LOPERAMIDE HYDROCHLORIDE 
    loperamide hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)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:58602-701-011 in 1 CARTON12/15/2015
    16 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:58602-701-022 in 1 CARTON12/15/2015
    26 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:58602-701-764 in 1 CARTON12/15/2015
    36 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20654812/15/2015
    Labeler - Aurohealth LLC (078728447)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aurobindo Pharma Limited650381903ANALYSIS(58602-701) , MANUFACTURE(58602-701)
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