IMODIUM A-D- loperamide hydrochloride tablet, film coated 
Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division

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Imodium ®

A-D

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

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

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

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
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 CARTON07/13/201510/31/2021
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)

Revised: 9/2021
Document Id: cd230883-bf53-7a6c-e053-2a95a90aefee
Set id: 01da76d0-1979-4c45-9d39-c72ae4e4ffe2
Version: 9
Effective Time: 20210929
 
Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division