• 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 ...
(in each tablet)
Loperamide Hydrochloride USP 2 mg
Simethicone USP 125 mg
Anti-diarrheal
Anti-gas
relieves symptoms of diarrhea plus bloating, pressure and cramps, commonly referred to as gas
Allergry alert: Do not user if you have ever had a rash or other allergic reaction to loperamide hydrochloride
Taking more than directed can cause serious heart problems or death.
• if you have bloody or black stool
• if you have difficulty swallowing
• fever
• mucus in the stool
• a history of liver disease
• a history of abnormal heart rhythm
you are taking a prescription drug. Loperamide may interact with certain prescription drugs.
tiredness, drowsiness or dizziness may occur. Be careful when driving or operating machinery.
• 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
If pregnant or breast-feeding, ask a health professional before use.
ask a health professional before use.
In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
• 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 |
• 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
acesulfame potassium, croscarmellose sodium, dibasic calcium phosphate, microcrystalline cellulose, stearic acid and vanilla flavor
Loperamide Hydrochloride and Simethicone Tablets 2 mg/125 mg
| Class | Version | Type | Effective |
|---|---|---|---|
| DIMETHICONE Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20180813 |
| LOPERAMIDE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0860010278123 | GTIN-13: 0860010278123 EAN-13: 0860010278123 GTIN-12: 860010278123 UPC-A: 860010278123 GTIN storage (14 digits): 00860010278123 | IBS-10.jpg |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 10f838ef-a72b-645d-80f8-e2255205c3b1 | Product name | 6 | 20240805 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 84441-713-10 | Loperamide Hydrochloride and Simethicone | 100 in 1 BOTTLE | TABLET | 100 | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 84441-713 | 84441-713-10 |
Every source-derived ingredient row is available through these pages.
| 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 |
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A211438-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | LOPERAMIDE HYDROCHLORIDE; SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2021-06-17 |
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A211438-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2021-06-17 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A211438-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2021-06-17 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A211438-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2021-06-17 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211438-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2021-06-17 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A211438-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2021-06-17 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211438-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2021-06-17 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211438-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2021-06-17 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211438-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2021-06-17 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211438-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2021-06-17 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A211438-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2021-06-17 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A211438-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2021-06-17 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A211438-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2021-06-17 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A211438-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2021-06-17 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A211438-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2021-06-17 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A211438-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2021-06-17 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A211438-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2021-06-17 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A211438-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2021-06-17 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A211438-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2021-06-17 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A211438-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2021-06-17 | 4b0b4de00fa7… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A211438-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2021-06-17 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A211438-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2021-06-17 | 782e0a99824c… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A211438-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2021-06-17 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A211438-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2021-06-17 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A211438-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2021-06-17 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A211438-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2021-06-17 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A211438-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2021-06-17 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A211438-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2021-06-17 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A211438-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2021-06-17 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A211438-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2021-06-17 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A211438-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2021-06-17 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A211438-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2021-06-17 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A211438-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2021-06-17 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A211438-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2021-06-17 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A211438-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2021-06-17 | cb3db0bc1861… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A211438-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2021-06-17 | a50c72e98297… |
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Loperamide Hydrochloride and Simethicone | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | IMO-GEN LABS LLC | 41d6dba5-e411-c8d2-e063-6294a90ae8fa | 2025-10-23 | Warnings | 84441-713-10 84441-713 84441071310 41d6dba5-e412-c8d2-e063-6294a90ae8fa 41d6dba5-e411-c8d2-e063-6294a90ae8fa |
Adverse event summaries are temporarily unavailable. Other product information remains available.