IMODIUM MULTI-SYMPTOM RELIEF- loperamide hydrochloride and dimethicone tablet 
Johnson & Johnson Consumer Inc.

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IMODIUM

Multi-Symptom Relief

Drug Facts

Active ingredients (in each caplet)Purposes
Loperamide HCl 2 mgAnti-diarrheal
Simethicone 125 mgAnti-gas

Uses

relieves symptoms of diarrhea plus bloating, pressure and cramps, commonly referred to as gas

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
  • if you have difficulty swallowing

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.
  • you have difficulty swallowing the caplet

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

Other information

Inactive ingredients

acesulfame potassium, croscarmellose sodium, dibasic calcium phosphate, flavor, microcrystalline cellulose, stearic acid

Questions or comments?

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

PRINCIPAL DISPLAY PANEL

NDC 50580-338-61

Imodium ®

Loperamide HCl, 2 mg /Simethicone, 125 mg Antidiarrheal/Anti-gas

Multi-Symptom Relief

Caplet

Relieves symptoms
of diarrhea plus

24 Caplets*

*capsule-shaped tablets

Actual Size

Principal Display Panel

IMODIUM  MULTI-SYMPTOM RELIEF
loperamide hydrochloride and dimethicone tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50580-338
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LOPERAMIDE HYDROCHLORIDE (UNII: 77TI35393C) (LOPERAMIDE - UNII:6X9OC3H4II) LOPERAMIDE HYDROCHLORIDE2 mg
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE125 mg
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorwhiteScore2 pieces
ShapeOVALSize16mm
FlavorImprint Code IMO;2;125
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50580-338-122 in 1 CARTON07/01/2008
16 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:50580-338-183 in 1 CARTON07/01/2008
26 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:50580-338-421 in 1 CARTON07/01/200809/07/2021
342 in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:50580-338-301 in 1 CARTON07/01/200809/07/2021
430 in 1 BOTTLE; Type 0: Not a Combination Product
5NDC:50580-338-602 in 1 PACKAGE06/14/201307/31/2021
51 in 1 CARTON
530 in 1 BOTTLE; Type 0: Not a Combination Product
6NDC:50580-338-614 in 1 CARTON06/24/2019
66 in 1 BLISTER PACK; Type 0: Not a Combination Product
7NDC:50580-338-644 in 1 CARTON02/26/2024
76 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02114007/01/2008
Labeler - Johnson & Johnson Consumer Inc. (878046358)

Revised: 4/2024
Document Id: 1638f86e-627d-69f8-e063-6394a90aafe8
Set id: ecb91e47-2b0c-47c8-9256-4623d8bc825e
Version: 18
Effective Time: 20240416
 
Johnson & Johnson Consumer Inc.