Overview
Simethicone is a silicon based surfactant that decreases the surface tension of gastrointestinal gas bubbles to facilitate their elimination. It has a favourable safety profile as it is not systemically absorbed. Simethicone has been in use since the 1940s but was granted FDA approval in 1952.
Indication
Simethicone is indicated for the treatment of bloating, pressure, and cramps caused by gas. Simethicone is also used as part of bowel preparation for colonoscopies.
Associated Conditions
- Abdominal Cramping
- Abdominal Pain
- Bloating
- Colic
- Diarrhea
- Distension
- Distention
- Dyspepsia
- Flatulence
- Gastric Ulcer
- Gastritis
- Heartburn
- Hiatus Hernia
- Hyperacidity
- Pain
- Pancreatic Insufficiency
- Peptic Esophagitis
- Peptic Ulcer
- Reflux Acid
- Stomach ache
- Gastrointestinal cramping
- Gastrointestinal cramps caused by Gas
- Gastrointestinal spasms
- Stomach cramps
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/02/06 | Phase 4 | Recruiting | |||
2024/09/03 | Not Applicable | Completed | Asian Institute of Gastroenterology, India | ||
2024/03/20 | N/A | Completed | Hospital St. Joseph, Marseille, France | ||
2023/07/19 | Not Applicable | Completed | Asian Institute of Gastroenterology, India | ||
2022/01/03 | Phase 3 | Completed | |||
2021/03/17 | Phase 2 | UNKNOWN | Dinara Zhumanbayeva | ||
2021/01/14 | Phase 4 | UNKNOWN | Alfredo Di Leo | ||
2020/12/14 | Not Applicable | UNKNOWN | The President Stanisław Wojciechowski State University of Applied Sciences in Kalisz | ||
2020/07/27 | Phase 2 | Completed | The President Stanisław Wojciechowski State University of Applied Sciences in Kalisz | ||
2019/12/05 | Phase 1 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| COLIMIX SYRUP | SIN03333P | SYRUP | 50 mg/5 ml | 6/16/1989 | |
| CENVITE TABLET | SIN07046P | TABLET | 30 mg | 6/5/1992 | |
| E-Z-GAS II GRANULES | SIN06442P | GRANULE | 0.04 g/4 g | 7/11/1991 | |
| ACOLIC SYRUP | SIN10344P | SYRUP | 50 mg/5 ml | 11/4/1998 | |
| ALUMAG PLUS TABLETS | SIN03547P | TABLET | 30 mg | 6/6/1989 | |
| MYLOM DROPS 40 mg/0.6 ml | SIN02382P | SOLUTION | 40 mg/0.6 ml | 11/9/1988 | |
| RIDWIND BABY DROP | SIN09136P | EMULSION | 100 mg/ml | 1/16/1997 | |
| AXCEL EVILINE TABLET | SIN06592P | TABLET | 20 mg | 9/26/1991 | |
| SIMCONE CHEWABLE TABLET 80 mg | SIN11621P | TABLET | 80 mg | 8/10/2001 | |
| POLYSILIC III SUSPENSION | SIN03406P | SUSPENSION | 30 mg/5 ml | 6/16/1989 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Simethicone Emulsion | 国药准字H20249391 | 化学药品 | 口服乳剂 | 11/15/2024 | |
| Simethicone Emulsion | 国药准字H20253295 | 化学药品 | 口服乳剂 | 1/24/2025 | |
| Simethicone Emulsion | 国药准字H20243534 | 化学药品 | 口服乳剂 | 4/17/2024 | |
| Simethicone Emulsion | 国药准字H20173062 | 化学药品 | 口服乳剂 | 2/11/2022 | |
| Simethicone Emulsion | 国药准字HJ20160197 | 化学药品 | 口服乳剂 | 9/10/2024 | |
| Simethicone Emulsion | 国药准字H20234544 | 化学药品 | 口服乳剂 | 11/28/2023 | |
| Simethicone Emulsion | 国药准字H20243844 | 化学药品 | 口服乳剂 | 5/28/2024 | |
| Simethicone Emulsion | 国药准字H20249695 | 化学药品 | 口服乳剂 | 12/6/2024 | |
| Simethicone Emulsion | 国药准字H20249752 | 化学药品 | 口服乳剂 | 12/17/2024 | |
| Simethicone Emulsion | 国药准字H20223383 | 化学药品 | 口服乳剂 | 6/16/2022 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| VIDA-MECO SUSP ORAL | N/A | N/A | N/A | 2/6/1987 | |
| BAROS EFFERVESCENT GRANULES | N/A | N/A | N/A | 9/6/1988 | |
| ALBISTA CAPSULES | N/A | N/A | N/A | 11/6/2024 | |
| SIMWELL CHEWABLE TABLETS | N/A | N/A | N/A | 11/6/2017 | |
| GASEDIN-U EXTRA STOMACH CHEWABLE TAB | N/A | N/A | N/A | 12/28/2006 | |
| MAALOX PLUS TAB | N/A | N/A | N/A | 10/12/1978 | |
| SIGAS TABLET 80MG | N/A | N/A | N/A | 3/27/2014 | |
| FEDRA-GEL-S CHEWABLE TAB | N/A | N/A | N/A | 7/4/1984 | |
| WEICHI TAB | N/A | N/A | N/A | 5/3/1995 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| GASBUSTERS simethicone 200mg capsule blister pack | 80295 | Medicine | A | 10/31/2001 | |
| GAS-MED simethicone 200mg soft gelatin capsules blister pack | 444752 | Medicine | A | 3/27/2024 | |
| APOHEALTH DIARRHOEA RELIEF PLUS chewable tablet blister pack | 235981 | Medicine | A | 4/9/2015 | |
| MYLANTA 2go ANTACID ORIGINAL chewable tablet (reformulation) blister pack | 118511 | Medicine | A | 5/11/2005 | |
| COLES GAS RELIEF simethicone 200mg soft gelatin capsules blister pack | 491326 | Medicine | A | 6/10/2025 | |
| CHEMISTS’ OWN DIARRHOEA RELIEF PLUS chewable tablet blister pack | 238207 | Medicine | A | 5/18/2015 | |
| DE-GAS simethicone 100mg capsule blister pack | 10395 | Medicine | A | 7/4/1991 | |
| MYLANTA DOUBLE STRENGTH oral liquid bottle (reformulation 2) | 126090 | Medicine | A | 3/10/2006 | |
| MYLANTA ANTACID DOUBLE STRENGTH oral liquid bottle | 294406 | Medicine | A | 9/27/2017 | |
| MYLANTA P ANTACID oral liquid bottle (reformulation) | 121994 | Medicine | A | 9/19/2005 |
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