Label: LOPERAMIDE HYDROCHLORIDE tablet

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

Drug Label Information

Updated May 2, 2022

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  • ACTIVE INGREDIENT (IN EACH CAPLET)

    Loperamide HCl USP, 2 mg

  • PURPOSE

    Anti-diarrheal

  • USE(S)

    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

    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

    •
    diarrhea lasts for more than 2 days
    •
    symptoms get worse
    •
    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;
    ½ 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;
    ½ 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 between 20° – 25° C (68° – 77° F)
    •
    see side panel for lot number and expiration date
    •
    TAMPER EVIDENT: THIS PRODUCT 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, FD&C blue no.1, hydrogenated vegetable oil, magnesium stearate, powdered cellulose, pregelatinized starch

  • QUESTIONS?

    call 1800-406-7984

    Keep the carton. It contains important information.

    Distributed by:

    Ohm Laboratories Inc.

    New Brunswick, NJ 08901

    Relabeled by:

    Proficient Rx LP

    Thousand Oaks, CA 91320

  • PRINCIPAL DISPLAY PANEL

    NDC 63187-462-12

    Loperamide HCl Tablets, USP 2 mg

    Anti-Diarrheal

    12 CAPLETS†

    Each caplet(†capsule-shaped tablet) contains Loperamide HCl, USP 2 mg

    Controls The Symptoms of Diarrhea

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

    *This product is not manufactured or distributed by McNeil-PPC, distributor of Imodium® A-D.

    Imodium®is a registered trademark of Johnson & Johnson.

    63187-462-12
  • INGREDIENTS AND APPEARANCE
    LOPERAMIDE HYDROCHLORIDE 
    loperamide hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63187-462(NDC:51660-123)
    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
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    CROSPOVIDONE (120 .MU.M) (UNII: 68401960MK)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    GLYCERYL TRISTEARATE (UNII: P6OCJ2551R)  
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    Product Characteristics
    ColorgreenScore2 pieces
    ShapeCAPSULESize9mm
    FlavorImprint Code 123
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63187-462-1212 in 1 BLISTER PACK; Type 0: Not a Combination Product03/27/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07409102/01/1993
    Labeler - Proficient Rx LP (079196022)
    Establishment
    NameAddressID/FEIBusiness Operations
    Proficient Rx LP079196022REPACK(63187-462) , RELABEL(63187-462)
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