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 December 28, 2022

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  • Active ingredient (in each caplet)

    Loperamide HCl USP 2 mg

  • Purpose

    Antidiarrheal

  • 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 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.

  • 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.

  • SPL UNCLASSIFIED SECTION

    Do not use if individual packet is torn or open.

  • 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

  • Inactive ingredients

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

  • Questions?

    call 1-800-430-5490

  • PRINCIPAL DISPLAY PANEL

    MM1

    Antidiarrheal 100 count

  • Antidiarrheal Label

    Antidiarrheal

  • INGREDIENTS AND APPEARANCE
    ANTIDIARRHEAL RELIEF 
    loperamide hcl tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-1071
    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
    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
    Colorgreen (Bright Green) Score2 pieces
    ShapeCAPSULESize10mm
    FlavorImprint Code 123
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0498-1071-07100 in 1 CARTON11/07/2018
    1NDC:0498-1071-001 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07409104/29/2013
    Labeler - Honeywell Safety Products USA, Inc (079287321)
    Registrant - Honeywell Safety Products USA, Inc (079287321)
    Establishment
    NameAddressID/FEIBusiness Operations
    OHM LABORATORIES INC.184769029manufacture(0498-1071)
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