46f5c653-eec2-4729-8aaa-79f2e188eac3
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Loperamide HCl, USP 2 mg Simethicone, USP 125 mg
Purpose
Anti-diarrheal Anti-gas
Medication Information
Purpose
Anti-diarrheal Anti-gas
Description
Loperamide HCl, USP 2 mg Simethicone, USP 125 mg
Uses
Relieves symptoms of diarrhea plus bloating, pressure and cramps, commonly referred to as gas
Purposes
Anti-diarrheal
Anti-gas
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.
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
Questions?
call toll-free 1-866-933-6337
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
Principal Display Panel
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
Uses
Relieves symptoms of diarrhea plus bloating, pressure and cramps, commonly referred to as gas
Purposes
Anti-diarrheal
Anti-gas
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.
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
Questions?
call toll-free 1-866-933-6337
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
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)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:06:48.874563 · Updated: 2026-03-14T23:09:49.100948