Label: ANTIDIARRHEAL RELIEF- loperamide hcl tablet

  • NDC Code(s): 0498-1071-00, 0498-1071-07
  • Packager: Honeywell Safety Products USA, Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated November 6, 2018

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

  • Active ingredient (in each caplet)

    Loperamide HCl USP 2 mg

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  • Purpose

    Antidiarrheal

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  • Use

    controls symptoms of diarrhea, including Travelers' Diarrhea

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  • Warnings

    Allergy alert: do not use if you have ever had a rash or other allergic reaction to loperamide HCl

    Heart attack: 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

    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 doctorif

    • diarrhea lasts for more than 2 days
    • symptoms get worse
    • you get abdominal swelling or bulging.

    These may be signsor a serious condition.

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  • If pregnant or breast-feeding,

    ask a health professional before use.

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  • Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away.

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  • SPL UNCLASSIFIED SECTION

    Do not use if individual packet is torn or open.

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  • 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 (60-95Ibs) 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(48-59lbs) 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 under 6 years (up to 47 lbs) ask a doctor

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  • Inactive ingredients

    anhydrous lactose, croscarmellose sodium, crospovidone, D&C yellow #10, FD&C blue #1, hydrogenated vegetable oil, magnesium stearate, powdered cellulose, pregelatinized starch

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  • Questions?

    call 1-800-430-5490

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  • PRINCIPAL DISPLAY PANEL

    MM1

    Antidiarrheal 100 count

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  • Antidiarrheal Label
  • INGREDIENTS AND APPEARANCE
    ANTIDIARRHEAL RELIEF 
    loperamide hcl tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0498-1071
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    LOPERAMIDE HYDROCHLORIDE (UNII: 77TI35393C) (LOPERAMIDE - UNII:6X9OC3H4II) LOPERAMIDE HYDROCHLORIDE 2 mg
    Inactive Ingredients
    Ingredient Name Strength
    LACTOSE (UNII: J2B2A4N98G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    CROSPOVIDONE (UNII: 68401960MK)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
    CORN OIL (UNII: 8470G57WFM)  
    Product Characteristics
    Color green (Bright Green) Score 2 pieces
    Shape CAPSULE Size 10mm
    Flavor Imprint Code 123
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0498-1071-07 100 in 1 CARTON 11/07/2018
    1 NDC:0498-1071-00 1 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA074091 04/29/2013
    Labeler - Honeywell Safety Products USA, Inc (079287321)
    Registrant - Honeywell Safety Products USA, Inc (079287321)
    Establishment
    Name Address ID/FEI Business Operations
    Honeywell Safety Products USA, Inc 079287321 repack(0498-1071)
    Establishment
    Name Address ID/FEI Business Operations
    OHM LABORATORIES INC. 184769029 manufacture(0498-1071)
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