Label: LOPERAMIDE HYDROCHLORIDE tablet

  • NDC Code(s): 53329-664-57
  • Packager: Medline Industries, LP
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated December 14, 2022

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  • Active ingredient (in each caplet)

    Loperamide HCl 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 HCI
    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 over2 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 between 20° - 25° C (68° - 77° F)
    • see side panel for lot number and expiration date
    • TAMPER EVIDENT: THIS PRODUCT IS PROTECTED WITH SEALED BLISTER UNITS. DO NOT USE IF ANY ARE TORN OR BROKEN.
  • Inactive ingredients

    anhydrous lactose, croscarmellose sodium, crospovidone, D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, hydrogenated vegetable oil, magnesium stearate, powdered cellulose, pregelatinized starch

  • Questions or comments?

    Call toll free 1-800-MEDLINE (633-5463)
    Monday-Friday 9AM-5PM CST

  • Manufacturing Information

    Packaged for:
    Medline Industries, LP
    Three Lakes Drive, Northfield, IL 60093 USA
    Packaged in USA with domestic and foreign materials
    www.medline.com
    1-800-MEDLINE (633-5463)
    REF: OTCS0801C2
    V1 RG22OHM

  • Package Label

    V1 RG22OHM

  • INGREDIENTS AND APPEARANCE
    LOPERAMIDE HYDROCHLORIDE 
    loperamide hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-664
    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)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    CROSPOVIDONE (UNII: 68401960MK)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    TRISTEARIN (UNII: P6OCJ2551R)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
    STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorgreenScore2 pieces
    ShapeCAPSULESize9mm
    FlavorImprint Code 123
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53329-664-5712 in 1 BLISTER PACK; Type 0: Not a Combination Product02/01/1993
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07409102/01/1993
    Labeler - Medline Industries, LP (025460908)
    Registrant - Medline Industries, LP (025460908)
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