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

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IMODIUM

McNeil Consumer Healthcare Div McNeil-PPC, Inc

Imodium A-D


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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

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
  • find right dose on chart. 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 10 mg
  • store between 20-25°C (68-77°F)
  • do not use if carton or blister unit is open or torn
  • see side panel for lot number and expiration date

Inactive ingredients

colloidal silicon dioxide, dibasic calcium phosphate dihydrate, D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, magnesium stearate, microcrystalline cellulose

Questions or comments?

call 1-877-895-3665

PRINCIPAL DISPLAY PANEL

NDC 50580-295-06

Imodium ®
A-D
Loperamide HCl, 2 mg
Anti-Diarrheal

Anti-Diarrheal

Controls the symptoms
of diarrhea

6 Caplets

IMODIUM

IMODIUM

Loperamide hydrochloride TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:50580-295
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
LOPERAMIDE HYDROCHLORIDE LOPERAMIDE 2 mg

Inactive Ingredients

Ingredient Name Strength
SILICON DIOXIDE
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE
D&C YELLOW NO. 10
FD&C BLUE NO. 1
MAGNESIUM STEARATE
ALUMINUM OXIDE
cellulose, microcrystalline

Product Characteristics

Color Size Imprint Code Shape
GREEN (Light green) 11 mm IMODIUM;A;D;2mg OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 6 in 1 BLISTER PACK
2 6 in 1 BLISTER PACK
3 6 in 1 BLISTER PACK
4 6 in 1 BLISTER PACK
5 6 in 1 BLISTER PACK
6 2 in 1 POUCH
7 NDC:50580-295-55 2 in 1 POUCH
8 6 in 1 BLISTER PACK
9 6 in 1 BLISTER PACK
10 NDC:50580-295-84 8 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019860 1989-12-01


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Be sure to consult your doctor before taking any medication!
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