Active Ingredients And Purpose
ACTIVE INGREDIENT(S)
(in each tablet) Loperamide Hydrochloride USP 2 mg Simethicone USP 125 mg
PURPOSES
Anti-diarrheal Anti-gas
Loperamide Hydrochloride and Simethicone
- Manufacturer
- IMO-GEN LABS LLC
- Effective date
- 2025-10-23
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-01 01:40:57
Key Label Information#
Uses
USE(S)
relieves symptoms of diarrhea plus bloating, pressure and cramps, commonly referred to as gas
Warnings
WARNINGS
Allergry alert: Do not user if you have ever had a rash or other allergic reaction to loperamide hydrochloride
Directions And Dosage
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
Other Label Information
INACTIVE INGREDIENTS
acesulfame potassium, croscarmellose sodium, dibasic calcium phosphate, microcrystalline cellulose, stearic acid and vanilla flavor
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Loperamide Hydrochloride and Simethicone Tablets 2 mg/125 mg
Label Images#
DailyMed RxNorm Mappings#
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| DIMETHICONE Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20180813 |
| LOPERAMIDE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 10f838ef-a72b-645d-80f8-e2255205c3b1 | Product name | 6 | 20240805 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 84441-713-10 | Loperamide Hydrochloride and Simethicone | 100 in 1 BOTTLE | TABLET | 100 | 1 |
Products#
- Loperamide Hydrochloride and Simethicone
- LOPERAMIDE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 84441-713 | 84441-713-10 |
Ingredients#
| Name | UNII | Kind |
|---|---|---|
| DIMETHICONE | 92RU3N3Y1O | ACTIB |
| LOPERAMIDE HYDROCHLORIDE | 77TI35393C | ACTIB |
| ACESULFAME POTASSIUM | 23OV73Q5G9 | IACT |
| CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS | L11K75P92J | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| CELLULOSE, MICROCRYSTALLINE | OP1R32D61U | IACT |
| CROSCARMELLOSE SODIUM | M28OL1HH48 | IACT |
Complete SPL Sections#
ACTIVE INGREDIENT(S)
(in each tablet) Loperamide Hydrochloride USP 2 mg Simethicone USP 125 mg
PURPOSES
Anti-diarrheal Anti-gas
USE(S)
relieves symptoms of diarrhea plus bloating, pressure and cramps, commonly referred to as gas
WARNINGS
Allergry alert: Do not user if you have ever had a rash or other allergic reaction to loperamide hydrochloride
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
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
INACTIVE INGREDIENTS
acesulfame potassium, croscarmellose sodium, dibasic calcium phosphate, microcrystalline cellulose, stearic acid and vanilla flavor
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Loperamide Hydrochloride and Simethicone Tablets 2 mg/125 mg