IMODIUM description, usages, side effects, indications, overdosage, supplying and lots more!

Menu
Search

IMODIUM

McNeil Consumer Healthcare Div. McNeil-PPC, Inc

Imodium Multi-Symptom Relief


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Purpose

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

IMODIUM 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 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
(60-95 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

IMODIUM 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

IMODIUM

IMODIUM

loperamide hydrochloride and dimethicone TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:50580-338
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
LOPERAMIDE HYDROCHLORIDE LOPERAMIDE 2 mg
DIMETHICONE 125 mg

Inactive Ingredients

Ingredient Name Strength
ACESULFAME POTASSIUM
CROSCARMELLOSE SODIUM
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE
cellulose, microcrystalline
STEARIC ACID

Product Characteristics

Color Size Imprint Code Shape
WHITE 16 mm IMO;2;125 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:50580-338-02 2 in 1 POUCH
2 6 in 1 BLISTER PACK
3 6 in 1 BLISTER PACK
4 6 in 1 BLISTER PACK
5 2 in 1 POUCH
6 42 in 1 BOTTLE
7 54 in 1 BOTTLE
8 30 in 1 BOTTLE
9 NDC:50580-338-30 1 in 1 CARTON
10 NDC:50580-338-60 2 in 1 PACKAGE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021140 2008-07-01


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
Copyright © 2014. drugs-library.com. All rights reserved. Information on drugs-library.com is provided for educational purposes only and is not to be used for medical advice, diagnosis or treatment.
Support info@drugs-library.com.