Imodium

Imodium
SPL v23
SPL
SPL Set ID ecb91e47-2b0c-47c8-9256-4623d8bc825e
Route
ORAL
Published
Effective Date 2024-05-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Loperamide (2 mg) Dimethicone (125 mg)
Inactive Ingredients
Croscarmellose Sodium Acesulfame Potassium Anhydrous Dibasic Calcium Phosphate Microcrystalline Cellulose Stearic Acid

Identifiers & Packaging

Pill Appearance
Imprint: IMO;2;125 Shape: oval Color: white Size: 16 mm Score: 2
Marketing Status
NDA Active Since 2008-07-01 Until 2021-07-31

Description

Drug Facts


Medication Information

Description

Drug Facts

Uses

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

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 53414-9

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

Section 55105-1
Active ingredients (in each caplet) Purposes
Loperamide HCl 2 mg Anti-diarrheal
Simethicone 125 mg Anti-gas
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)
  • take with a full (8 oz.) glass of water
  • 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;



    ½ 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;



    ½ caplet after each subsequent loose stool; but no more than 2 caplets 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
Do Not Use
  • if you have bloody or black stool
  • if you have difficulty swallowing
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 caplet contains: calcium 165 mg, sodium 3 mg
  • store between 20-25°C (68-77°F). Protect from light.
  • do not use if blister unit is torn or broken
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 50580-338-12

Imodium ®



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

Multi-Symptom Relief



Caplet

Relieves symptoms

of diarrhea plus

  • Cramps & Pressure
  • Bloating
  • Gas

12 Caplets*

*capsule-shaped tablets

Actual Size

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
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

Uses

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

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 53414-9 (53414-9)

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

Section 55105-1 (55105-1)
Active ingredients (in each caplet) Purposes
Loperamide HCl 2 mg Anti-diarrheal
Simethicone 125 mg Anti-gas
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)
  • take with a full (8 oz.) glass of water
  • 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;



    ½ 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;



    ½ caplet after each subsequent loose stool; but no more than 2 caplets 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
Do Not Use (Do not use)
  • if you have bloody or black stool
  • if you have difficulty swallowing
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 caplet contains: calcium 165 mg, sodium 3 mg
  • store between 20-25°C (68-77°F). Protect from light.
  • do not use if blister unit is torn or broken
Inactive Ingredients (Inactive ingredients)

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

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 50580-338-12

Imodium ®



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

Multi-Symptom Relief



Caplet

Relieves symptoms

of diarrhea plus

  • Cramps & Pressure
  • Bloating
  • Gas

12 Caplets*

*capsule-shaped tablets

Actual Size

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.
  • you have difficulty swallowing the caplet
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)