Label: LOPERAMIDE HYDROCHLORIDE tablet

  • NDC Code(s): 51660-123-06, 51660-123-12, 51660-123-24
  • Packager: Ohm Laboratories Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated April 3, 2019

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each caplet)

    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 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 2-5 years

    (34 to 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?

    call 1-800-406-7984

  • SPL UNCLASSIFIED SECTION

    Keep the carton. It contains important information.

    Distributed by:
    Ohm Laboratories Inc.
    New Brunswick, NJ 08901

    R0319

  • PRINCIPAL DISPLAY PANEL

    NDC 51660-123-06

    Compare To
    the active ingredient of
    Imodium® A-D

    See New Warnings
    and Directions

    ohm®

    Loperamide Hydrochloride
    Tablets USP, 2 mg

    Anti-Diarrheal

    Controls the symptoms of diarrhea

    6 Caplets*
    Each caplet (*capsule-shaped tablet) contains Loperamide Hydrochloride USP, 2 mg

    Ohm® is a registered trademark of Sun Pharmaceutical Industries, Inc. All other trademarks are property of their respective owners.

    Ohm Loperamide 6 count Blister Carton
  • INGREDIENTS AND APPEARANCE
    LOPERAMIDE HYDROCHLORIDE 
    loperamide hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)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
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    HYDROGENATED COTTONSEED OIL (UNII: Z82Y2C65EA)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorgreenScore2 pieces
    ShapeCAPSULESize9mm
    FlavorImprint Code 123
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51660-123-061 in 1 CARTON02/01/1993
    16 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:51660-123-122 in 1 CARTON02/01/1993
    26 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:51660-123-244 in 1 CARTON02/01/1993
    36 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07409102/01/1993
    Labeler - Ohm Laboratories Inc. (184769029)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ohm Laboratories Inc.184769029MANUFACTURE(51660-123)