Imodium

Imodium
SPL v10
SPL
SPL Set ID 76a976d5-8bee-4158-a94d-7fbfc5544fd4
Route
ORAL
Published
Effective Date 2020-07-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Loperamide (1 mg)
Inactive Ingredients
Carboxymethylcellulose Sodium, Unspecified Form Caramel D&c Yellow No. 10 Fd&c Blue No. 1 Glycerin Microcrystalline Cellulose Propylene Glycol Sodium Benzoate Sucralose Titanium Dioxide Water Xanthan Gum Anhydrous Citric Acid

Identifiers & Packaging

Pill Appearance
Color: green
Marketing Status
NDA Active Since 2004-07-01
Description

Drug Facts

Purpose

Anti-diarrheal

Medication Information

Purpose

Anti-diarrheal

Description

Drug Facts

Use

controls symptoms of diarrhea, including Travelers' Diarrhea

Section 42229-5

Drug Facts

Section 50565-1

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)

Section 50567-7

When using this product tiredness, drowsiness or dizziness may occur. Be careful when driving or operating machinery.

Section 50568-5

Ask a doctor or pharmacist before use if you are taking a prescription drug. Loperamide may interact with certain prescription drugs.

Section 50570-1

Do not use if you have bloody or black stool

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

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.
  • shake well before using
  • use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.
  • mL = milliliter
adults and children 12 years and over 30 mL after the first loose stool; 15 mL after each subsequent loose stool; but no more than 60 mL in 24 hours
children 9-11 years (60-95 lbs) 15 mL after first loose stool; 7.5 mL after each subsequent loose stool; but no more than 45 mL in 24 hours
children 6-8 years (48-59 lbs) 15 mL after first loose stool; 7.5 mL after each subsequent loose stool; but no more than 30 mL 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
Heart Alert

Taking more than directed can cause serious heart problems or death

Allergy Alert

Do not use if you have ever had a rash or other allergic reaction to loperamide HCl

Other Information
  • each 30 mL contains: sodium 16 mg
  • store between 20-25°C (68-77°F)
  • do not use if outer neck band imprinted with "Imodium®" or inner neck band imprinted with "Sealed For Your Safety" is broken or missing
Inactive Ingredients

anhydrous citric acid, caramel color, D&C yellow no. 10, FD&C blue no. 1, flavor, glycerin, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, purified water, simethicone emulsion, sodium benzoate, sucralose, titanium dioxide, xanthan gum

Questions Or Comments?

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

Principal Display Panel

NDC 50580-134-08

Imodium ®

A-D



Loperamide HCl Oral Solution

Anti-Diarrheal

1 mg per 7.5 mL

Anti-Diarrheal

Oral Solution

Controls the symptoms

of diarrhea

8 fl oz

(240 mL)

Mint Flavor

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.
Active Ingredient (in Each 7.5 Ml)

Loperamide HCl 1 mg

Ask A Doctor Before Use If You Have
  • fever
  • mucus in the stool
  • a history of liver disease
  • a history of abnormal heart rhythm

Structured Label Content

Use

controls symptoms of diarrhea, including Travelers' Diarrhea

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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)

Section 50567-7 (50567-7)

When using this product tiredness, drowsiness or dizziness may occur. Be careful when driving or operating machinery.

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are taking a prescription drug. Loperamide may interact with certain prescription drugs.

Section 50570-1 (50570-1)

Do not use if you have bloody or black stool

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Purpose

Anti-diarrheal

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.
  • shake well before using
  • use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.
  • mL = milliliter
adults and children 12 years and over 30 mL after the first loose stool; 15 mL after each subsequent loose stool; but no more than 60 mL in 24 hours
children 9-11 years (60-95 lbs) 15 mL after first loose stool; 7.5 mL after each subsequent loose stool; but no more than 45 mL in 24 hours
children 6-8 years (48-59 lbs) 15 mL after first loose stool; 7.5 mL after each subsequent loose stool; but no more than 30 mL 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
Heart Alert (Heart alert)

Taking more than directed can cause serious heart problems or death

Allergy Alert (Allergy alert)

Do not use if you have ever had a rash or other allergic reaction to loperamide HCl

Other Information (Other information)
  • each 30 mL contains: sodium 16 mg
  • store between 20-25°C (68-77°F)
  • do not use if outer neck band imprinted with "Imodium®" or inner neck band imprinted with "Sealed For Your Safety" is broken or missing
Inactive Ingredients (Inactive ingredients)

anhydrous citric acid, caramel color, D&C yellow no. 10, FD&C blue no. 1, flavor, glycerin, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, purified water, simethicone emulsion, sodium benzoate, sucralose, titanium dioxide, xanthan gum

Questions Or Comments? (Questions or comments?)

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

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 50580-134-08

Imodium ®

A-D



Loperamide HCl Oral Solution

Anti-Diarrheal

1 mg per 7.5 mL

Anti-Diarrheal

Oral Solution

Controls the symptoms

of diarrhea

8 fl oz

(240 mL)

Mint Flavor

Stop Use and Ask A Doctor If (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.
Active Ingredient (in Each 7.5 Ml) (Active ingredient (in each 7.5 mL))

Loperamide HCl 1 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • fever
  • mucus in the stool
  • a history of liver disease
  • a history of abnormal heart rhythm

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:05.939148 · Updated: 2026-03-14T23:10:18.112618