Loperamide Hydrochloride And Simethicone Tablets, 2 Mg/125 Mg (otc)
0199a50f-f367-40e7-8af0-745a959d3fde
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
(in each tablet) Loperamide Hydrochloride USP 2 mg Simethicone USP 125 mg
Purpose
Anti-diarrheal Anti-gas
Medication Information
Purpose
Anti-diarrheal Anti-gas
Description
(in each tablet) Loperamide Hydrochloride USP 2 mg Simethicone USP 125 mg
Use(s)
relieves symptoms of diarrhea plus bloating, pressure and cramps, commonly referred to as gas
Section 53414-9
If pregnant or breast-feeding,ask a health professional before use.
Purposes
Anti-diarrheal
Anti-gas
Warnings
Allergy alert:Do not use if you have ever had a rash or other allergic reaction to loperamide hydrochloride
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 tablets after the first loose stool; 1 tablet after each subsequent loose stool; but no more than 4 tablets in 24 hours
|
|
children 9-11 years (60-95 lbs) |
1 tablet after the first loose stool; 1/2 tablet after each subsequent loose stool; but no more than 3 tablets in 24 hours
|
|
children 6-8 years (48-59 lbs) |
1 tablet after the first loose stool; 1/2 tablet after each subsequent loose stool; but no more than 2 tablets 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
Other Information
• each tablet contains:
calcium 640 mg, very low sodium and potassium 5.838 mg
• store between 20 to 25°C (68 to 77°F). Protect from light.
• do not use if carton is open or if blister unit is open or torn
Active Ingredient(s)
(in each tablet)
Loperamide Hydrochloride USP 2 mg
Simethicone USP 125 mg
Inactive Ingredients
acesulfame potassium, croscarmellose sodium, dibasic calcium phosphate, microcrystalline cellulose, stearic acid and vanilla flavor
Questions Or Comments
call
1-888-588-1418
Manufactured for
FSA Store Inc.
473 Blair Rd Suite 100
PMB 24308 Dallas, TX 75231
Customer Help Line: 1-888-588-1418
Principal Display Panel
Loperamide Hydrochloride and Simethicone Tablets 2 mg/125 mg-1x6's carton
Loperamide Hydrochloride and Simethicone Tablets 2 mg/125 mg-6's foil
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.
• you have difficulty swallowing the tablet
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)
Ask A Doctor Before Use If You Have
• fever
• mucus in the stool
• a history of liver disease
• a history of abnormal heart rhythm
Ask A Doctor Or Pharmacist Before Use If
you aretaking a prescription drug. Loperamide may interact with certain prescription drugs.
Structured Label Content
Use(s) (USE(S))
relieves symptoms of diarrhea plus bloating, pressure and cramps, commonly referred to as gas
Section 53414-9 (53414-9)
If pregnant or breast-feeding,ask a health professional before use.
Purposes (PURPOSES)
Anti-diarrheal
Anti-gas
Warnings (WARNINGS)
Allergy alert:Do not use if you have ever had a rash or other allergic reaction to loperamide hydrochloride
Heart alert:Taking more than directed can cause serious heart problems or death
Directions (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 tablets after the first loose stool; 1 tablet after each subsequent loose stool; but no more than 4 tablets in 24 hours
|
|
children 9-11 years (60-95 lbs) |
1 tablet after the first loose stool; 1/2 tablet after each subsequent loose stool; but no more than 3 tablets in 24 hours
|
|
children 6-8 years (48-59 lbs) |
1 tablet after the first loose stool; 1/2 tablet after each subsequent loose stool; but no more than 2 tablets 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
Other Information (OTHER INFORMATION)
• each tablet contains:
calcium 640 mg, very low sodium and potassium 5.838 mg
• store between 20 to 25°C (68 to 77°F). Protect from light.
• do not use if carton is open or if blister unit is open or torn
Active Ingredient(s) (ACTIVE INGREDIENT(S))
(in each tablet)
Loperamide Hydrochloride USP 2 mg
Simethicone USP 125 mg
Inactive Ingredients (INACTIVE INGREDIENTS)
acesulfame potassium, croscarmellose sodium, dibasic calcium phosphate, microcrystalline cellulose, stearic acid and vanilla flavor
Questions Or Comments (QUESTIONS OR COMMENTS)
call
1-888-588-1418
Manufactured for
FSA Store Inc.
473 Blair Rd Suite 100
PMB 24308 Dallas, TX 75231
Customer Help Line: 1-888-588-1418
Principal Display Panel (PRINCIPAL DISPLAY PANEL)
Loperamide Hydrochloride and Simethicone Tablets 2 mg/125 mg-1x6's carton
Loperamide Hydrochloride and Simethicone Tablets 2 mg/125 mg-6's foil
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 get abdominal swelling or bulging. These may be signs of a serious condition.
• you have difficulty swallowing the tablet
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 right away. (1-800-222-1222)
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
Ask A Doctor Or Pharmacist Before Use If (ASK A DOCTOR OR PHARMACIST BEFORE USE IF)
you aretaking a prescription drug. Loperamide may interact with certain prescription drugs.
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:05:52.051331 · Updated: 2026-03-14T23:08:14.770901