Label: LOPERAMIDE HYDROCHLORIDE tablet

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

Drug Label Information

Updated April 26, 2012

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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.

  • 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.

    1385 Livingston Avenue

    North Brunswick, NJ 08902

  • PRINCIPAL DISPLAY PANEL

    NDC 54868-6312-0

    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 is the 12 count blister carton label for Loperamide hydrochloride tablets.
  • INGREDIENTS AND APPEARANCE
    LOPERAMIDE HYDROCHLORIDE 
    loperamide hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54868-6312(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 (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, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
    TRISTEARIN (UNII: P6OCJ2551R)  
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    Product Characteristics
    ColorgreenScore2 pieces
    ShapeCAPSULESize9mm
    FlavorImprint Code 123
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54868-6312-012 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07409109/24/2011
    Labeler - Physicians Total Care, Inc. (194123980)
    Establishment
    NameAddressID/FEIBusiness Operations
    Physicians Total Care, Inc.194123980relabel
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