Label: IMODIUM A-D- loperamide hydrochloride tablet, film coated

  • NDC Code(s): 50580-317-01, 50580-317-03, 50580-317-04, 50580-317-05, view more
    50580-317-06
  • Packager: Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated January 15, 2020

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each caplet)

    Loperamide HCl 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 HCl

    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 over2 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; 1/2 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; 1/2 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 at 20°-25°C (68°-77°F)
    • do not use if blister unit is broken or torn
  • Inactive ingredients

    anhydrous lactose, carnauba wax, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch

  • Questions or comments?

    1-877-895-3665 (toll-free) or 215-273-8755 (collect)

  • PRINCIPAL DISPLAY PANEL

    See New Warnings

    NDC 50580-317-06

    Imodium®
    A-D

    Loperamide Hydrochloride Tablets, 2mg
    Anti-Diarrheal

    Anti-Diarrheal
    Caplets

    Controls the symptoms
    of diarrhea

    Actual Size

    *Capsule-Shaped Tablets

    12 Caplets*

    Principal Display Panel
  • INGREDIENTS AND APPEARANCE
    IMODIUM   A-D
    loperamide hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50580-317
    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)  
    carnauba wax (UNII: R12CBM0EIZ)  
    hypromellose, unspecified (UNII: 3NXW29V3WO)  
    magnesium stearate (UNII: 70097M6I30)  
    microcrystalline cellulose (UNII: OP1R32D61U)  
    polyethylene glycol, unspecified (UNII: 3WJQ0SDW1A)  
    Product Characteristics
    ColorWHITEScore2 pieces
    ShapeOVALSize11mm
    FlavorImprint Code IMO;2;MG
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50580-317-011 in 1 CARTON07/13/2015
    16 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:50580-317-034 in 1 CARTON07/13/2015
    26 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:50580-317-046 in 1 CARTON07/13/201512/31/2018
    36 in 1 BLISTER PACK; Type 0: Not a Combination Product
    4NDC:50580-317-058 in 1 CARTON07/13/2015
    46 in 1 BLISTER PACK; Type 0: Not a Combination Product
    5NDC:50580-317-062 in 1 CARTON02/10/2020
    56 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07523207/13/2015
    Labeler - Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division (878046358)