Indications and uses
relieves symptoms of diarrhea plus bloating, pressure and cramps, commonly referred to as gas
Loperamide Hydrochloride and Simethicone Tablets, 2 mg/125 mg
- Manufacturer
- Granules India Ltd
- Effective date
- 2026-10-07
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- daily-update
- Hydrated at
- 2026-10-10 01:02:22
Label at a glance#
ProductLoperamide Hydrochloride and Simethicone
Active ingredientLOPERAMIDE HYDROCHLORIDE, DIMETHICONE
Label structure14 sections
Dosage and administration
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 ag 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 ...
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
Active ingredients (in each caplet)
Loperamide HCl, 2 mg
Simethicone, 125 mg
Purposes
Anti-diarrheal
Anti-gas
Uses
relieves symptoms of diarrhea plus bloating, pressure and cramps, commonly referred to as 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
Do not use
- if you have bloody or black stool
- if you have difficulty swallowing
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 are
taking a prescription drug. Loperamide may interact with certain prescription drugs.
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 caplet
If pregnant or breast-feeding, ask a health professional before use.
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)
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 ag
| 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 148.40 mg, sodium 1.40 mg
- store between 20-25°C (68-77°F). Protect from light.
- for blister: do not use if blister unit is torn or broken
Inactive Ingredients
acesulfame potassium, anhydrous dibasic calcium phosphate, colloidal silicon dioxide, croscarmellose sodium, flavor, microcrystalline cellulose, stearic acid.
Questions or comments?
Contact 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST
Manufactured by:
Granules India Limited
Hyderabad-500 081, INDIA
MADE IN INDIA
PRINCIPAL DISPLAY PANEL
Loperamide Hydrochloride and Simethicone Tablets 2 mg/125 mg
ANTI-DIARRHEAL / ANTI-GAS
Multi-Symptom Relief Caplet
Relieves symptoms of diarrhea plus
- Cramps & Pressure
- Bloating
- Gas
12 Caplets *
*capsule-shaped tablets
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0362207739696 | GTIN-13: 0362207739696 EAN-13: 0362207739696 GTIN-12: 362207739696 UPC-A: 362207739696 GTIN storage (14 digits): 00362207739696 | loper-simeth-carton.jpg, loper-simeth-foil.jpg |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 10f838ef-a72b-645d-80f8-e2255205c3b1 | Product name | 6 | 20240805 |
Products#
Every source-derived product name is available through these pages.
- Loperamide Hydrochloride and Simethicone
- LOPERAMIDE HYDROCHLORIDE
- LOPERAMIDE
- DIMETHICONE
- MICROCRYSTALLINE CELLULOSE
- CROSCARMELLOSE SODIUM
- ACESULFAME POTASSIUM
- STEARIC ACID
- ANHYDROUS DIBASIC CALCIUM PHOSPHATE
- SILICON DIOXIDE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 62207-739 | 62207-739-69 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| LOPERAMIDE HYDROCHLORIDE | 77TI35393C | ACTIB |
| DIMETHICONE | 92RU3N3Y1O | ACTIB |
| MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IACT |
| CROSCARMELLOSE SODIUM | M28OL1HH48 | IACT |
| ACESULFAME POTASSIUM | 23OV73Q5G9 | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| ANHYDROUS DIBASIC CALCIUM PHOSPHATE | L11K75P92J | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 3 | 2025-12-01 | full-release | 2026-06-01 01:19:00 |
Orange Book application contexts#
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A215981-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | LOPERAMIDE HYDROCHLORIDE; SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2022-08-29 |
Observed Orange Book product history#
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 | A215981-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2022-08-29 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A215981-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2022-08-29 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A215981-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2022-08-29 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A215981-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2022-08-29 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A215981-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2022-08-29 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A215981-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2022-08-29 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A215981-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2022-08-29 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A215981-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2022-08-29 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A215981-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2022-08-29 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A215981-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2022-08-29 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A215981-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2022-08-29 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A215981-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2022-08-29 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A215981-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2022-08-29 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A215981-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2022-08-29 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A215981-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2022-08-29 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A215981-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2022-08-29 | 8072bd15b7f6… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A215981-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2022-08-29 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A215981-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2022-08-29 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A215981-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2022-08-29 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A215981-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2022-08-29 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A215981-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2022-08-29 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A215981-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2022-08-29 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A215981-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2022-08-29 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A215981-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2022-08-29 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A215981-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2022-08-29 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A215981-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2022-08-29 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A215981-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2022-08-29 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A215981-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2022-08-29 | e64feba35796… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A215981-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2022-08-29 | a50c72e98297… |
openFDA label cross-check#
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 |
|---|---|---|---|---|---|---|
| 44e3c6ff-dda8-ee9e-e063-6394a90a03bb | e0c1693e-0e55-4368-a8a5-2f0882fbf952 | 2025-12-01 | Warnings | e0c1693e-0e55-4368-a8a5-2f0882fbf952 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.