46f5c653-eec2-4729-8aaa-79f2e188eac3

SPL v1
SPL
SPL Set ID 46f5c653-eec2-4729-8aaa-79f2e188eac3
Route
oral
Published
Effective Date 2025-07-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
loperamide (2 mg) dimethicone (125 mg)
Inactive Ingredients
acesulfame potassium silicon dioxide croscarmellose sodium anhydrous dibasic calcium phosphate microcrystalline cellulose stearic acid

Identifiers & Packaging

Pill Appearance
Imprint: L;II Shape: capsule Color: white Size: 17 mm Score: 2
Marketing Status
anda active Since 2021-09-10

Purpose

Anti-diarrheal Anti-gas

Description

Loperamide HCl, USP 2 mg Simethicone, USP 125 mg


Medication Information

Warnings

Allergy alert: Do not use if you have ever had a rash or other allergic reaction to Loperamide HCl.

Heart alert: Taking more than directed can cause serious heart problems or death.

Uses

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

Purpose

Anti-diarrheal 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

Other Information
  • each caplet contains: calcium 155 mg, sodium 3 mg
  • store at 20-25°C (68-77°F)
  • protect from light
Inactive Ingredients

acesulfame potassium, anhydrous dicalcium phosphate, colloidal silicon dioxide, croscarmellose sodium, microcrystalline cellulose, stearic acid, vanilla flavor

Description

Loperamide HCl, USP 2 mg Simethicone, USP 125 mg

Principal Display Panel

Questions?

call toll-free 1-866-933-6337

Purposes

Anti-diarrheal

Anti-gas

Do Not Use
  • if you have bloody or black stool
  • if you have difficulty swallowing
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 have difficulty swallowing the caplet
  • you get abdominal swelling or bulging. These may be signs of a serious condition.
Keep Out of Reach of Children

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

If Pregnant Or Breast Feeding,

ask a health professional before use.

Ask A Doctor Before Use If You Are

taking a prescription drug. Loperamide may interact with certain prescription drugs.

Active Ingredients (in Each Caplet)

Loperamide HCl, USP 2 mg

Simethicone, USP 125 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

Warnings

Allergy alert: Do not use if you have ever had a rash or other allergic reaction to Loperamide HCl.

Heart alert: Taking more than directed can cause serious heart problems or death.

Uses

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

Other Information (Other information)
  • each caplet contains: calcium 155 mg, sodium 3 mg
  • store at 20-25°C (68-77°F)
  • protect from light
Inactive Ingredients (Inactive ingredients)

acesulfame potassium, anhydrous dicalcium phosphate, colloidal silicon dioxide, croscarmellose sodium, microcrystalline cellulose, stearic acid, vanilla flavor

Principal Display Panel

Questions?

call toll-free 1-866-933-6337

Purposes

Anti-diarrheal

Anti-gas

Do Not Use (Do not use)
  • if you have bloody or black stool
  • if you have difficulty swallowing
When Using This Product (When using this product)

tiredness, drowsiness or dizziness may occur. Be careful when driving or operating machinery.

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 have difficulty swallowing the caplet
  • you get abdominal swelling or bulging. These may be signs of a serious condition.
Keep Out of Reach of Children (Keep out of reach of children)

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Ask A Doctor Before Use If You Are (Ask a doctor before use if you are)

taking a prescription drug. Loperamide may interact with certain prescription drugs.

Active Ingredients (in Each Caplet) (Active Ingredients (in each caplet))

Loperamide HCl, USP 2 mg

Simethicone, USP 125 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)