Indications and uses
Relieves symptoms of diarrhea plus bloating, pressure and cramps, commonly referred to as gas
Anti-Diarrheal/Anti-Gas Caplets
- Manufacturer
- YYBA CORP | OrBion Pharmaceuticals Private Limited
- Effective date
- 2025-07-24
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-01 01:11:08
Label at a glance#
ProductAnti-Diarrheal/Anti-Gas Caplets
Active ingredientLOPERAMIDE HYDROCHLORIDE, DIMETHICONE
Label structure16 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 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 caplet...
Storage and handling
each caplet contains: calcium 155 mg, sodium 3 mg store at 20-25°C (68-77°F) protect from light
Contacts and useful links#
Label contents#
Full prescribing information#
Active Ingredients (in each caplet)
Loperamide HCl, USP 2 mg
Simethicone, USP 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 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 have difficulty swallowing the caplet
- you get abdominal swelling or bulging. These may be signs of a serious condition.
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 (1-800-222-1222) right away.
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
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
Questions?
call toll-free 1-866-933-6337
Principal Display Panel
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 |
|---|---|---|---|---|---|---|
| 73581-178-24 | Anti-Diarrheal/Anti-Gas Caplets | 4 in 1 CARTON | TABLET | 4 | 1 | |
| 73581-178-24 | Anti-Diarrheal/Anti-Gas Caplets | 6 in 1 BLISTER PACK | TABLET | 6 | 1 |
Products#
Every source-derived product name is available through these pages.
- Anti-Diarrheal/Anti-Gas Caplets
- Loperamide Hydrochloride 2mg, Simethicone 125mg
- ACESULFAME POTASSIUM
- SILICON DIOXIDE
- CROSCARMELLOSE SODIUM
- ANHYDROUS DIBASIC CALCIUM PHOSPHATE
- MICROCRYSTALLINE CELLULOSE
- STEARIC ACID
- LOPERAMIDE HYDROCHLORIDE
- LOPERAMIDE
- DIMETHICONE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 73581-178 | 73581-178-24 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ACESULFAME POTASSIUM | 23OV73Q5G9 | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| CROSCARMELLOSE SODIUM | M28OL1HH48 | IACT |
| ANHYDROUS DIBASIC CALCIUM PHOSPHATE | L11K75P92J | IACT |
| MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| LOPERAMIDE HYDROCHLORIDE | 77TI35393C | ACTIB |
| DIMETHICONE | 92RU3N3Y1O | ACTIB |
Source Document#
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 |
|---|---|---|---|---|---|---|---|
| A213484-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | LOPERAMIDE HYDROCHLORIDE; SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2021-09-10 |
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 | A213484-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2021-09-10 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A213484-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2021-09-10 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A213484-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2021-09-10 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213484-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2021-09-10 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A213484-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2021-09-10 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213484-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2021-09-10 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213484-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2021-09-10 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213484-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2021-09-10 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213484-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2021-09-10 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213484-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2021-09-10 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213484-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2021-09-10 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A213484-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2021-09-10 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A213484-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2021-09-10 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A213484-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2021-09-10 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A213484-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2021-09-10 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A213484-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2021-09-10 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A213484-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2021-09-10 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A213484-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2021-09-10 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A213484-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2021-09-10 | 4b0b4de00fa7… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A213484-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2021-09-10 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A213484-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2021-09-10 | 782e0a99824c… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A213484-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2021-09-10 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A213484-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2021-09-10 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A213484-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2021-09-10 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A213484-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2021-09-10 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A213484-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2021-09-10 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A213484-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2021-09-10 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A213484-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2021-09-10 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A213484-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2021-09-10 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A213484-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2021-09-10 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A213484-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2021-09-10 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A213484-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2021-09-10 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A213484-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2021-09-10 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A213484-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2021-09-10 | cb3db0bc1861… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A213484-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2021-09-10 | 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 |
|---|---|---|---|---|---|---|
| Anti-Diarrheal/Anti-Gas Caplets | LOPERAMIDE HYDROCHLORIDE 2MG, SIMETHICONE 125MG | YYBA CORP | 46f5c653-eec2-4729-8aaa-79f2e188eac3 | 2025-07-24 | Warnings | 73581-178-24 73581-178 73581017824 3cb7329c-a47c-5d2f-e063-6394a90a053d 46f5c653-eec2-4729-8aaa-79f2e188eac3 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.