IMODIUM  MULTI-SYMPTOM RELIEF- loperamide hydrochloride and dimethicone tablet 
McNeil Consumer Healthcare Div. McNeil-PPC, 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

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 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
  • take only on an empty stomach (1 hour before or 2 hours after a meal)
  • find right dose on chart below. 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 under 6 years
(up to 47 lbs)		ask a doctor

Other information

  • each caplet contains: calcium 165 mg, sodium 4 mg
  • store between 20-25°C (68-77°F). Protect from light.
  • do not use if carton is open or if blister unit is open or torn
  • see side panel for expiration date and lot number

Inactive ingredients

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

Questions or comments?

call 1-877-895-3665

PRINCIPAL DISPLAY PANEL

NDC 50580-338-18

Imodium®
Loperamide HCl, 2 mg/ Simethicone, 125 mg Antidiarrheal/Anti-Gas

Multi-Symptom Relief

Diarrhea PLUS
• Cramps & Pressure
• Bloating
• Gas

18 Caplets

Principal Display Panel
IMODIUM   MULTI-SYMPTOM RELIEF
loperamide hydrochloride and dimethicone tablet
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:50580-338
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Loperamide Hydrochloride (Loperamide) Loperamide Hydrochloride2 mg
Dimethicone (Dimethicone) Dimethicone125 mg
Inactive Ingredients
Ingredient NameStrength
acesulfame potassium 
croscarmellose sodium 
calcium phosphate, dibasic, dihydrate 
cellulose, microcrystalline 
stearic acid 
Product Characteristics
ColorWHITEScore2 pieces
ShapeOVALSize16mm
FlavorImprint Code IMO;2;125
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50580-338-022 in 1 POUCH
2NDC:50580-338-122 in 1 CARTON
26 in 1 BLISTER PACK
3NDC:50580-338-183 in 1 CARTON
36 in 1 BLISTER PACK
4NDC:50580-338-244 in 1 CARTON
46 in 1 BLISTER PACK
5NDC:50580-338-2525 in 1 PACKAGE
52 in 1 POUCH
6NDC:50580-338-421 in 1 CARTON
642 in 1 BOTTLE
7NDC:50580-338-431 in 1 CARTON
754 in 1 BOTTLE
8NDC:50580-338-301 in 1 CARTON
830 in 1 BOTTLE
9NDC:50580-338-602 in 1 PACKAGE
9NDC:50580-338-301 in 1 CARTON
930 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02114007/01/2008
Labeler - McNeil Consumer Healthcare Div. McNeil-PPC, Inc (878046358)

Revised: 5/2013
Document Id: 0141f157-c824-4f7f-8ec2-e0b6e171dc71
Set id: ecb91e47-2b0c-47c8-9256-4623d8bc825e
Version: 1
Effective Time: 20130531
 
McNeil Consumer Healthcare Div. McNeil-PPC, Inc