Simethicone

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
Simethicone as Part of ERAS in Bariatric Surgery Patients	2025/02/06	NCT06812832	Phase 4	Recruiting	Madigan Army Medical Center
Impact of Timing of Premedication on Mucosal Visibility During Endoscopy-A Randomized Controlled Trial	2024/09/03	NCT06581783	Not Applicable	Completed	Asian Institute of Gastroenterology, India
Fixed Low-dose Simethicone Combined With Macrogol 4000 (PEG) Reduces Colon Bubble Formation in Colonoscopy	2024/03/20	NCT06319924	N/A	Completed	Hospital St. Joseph, Marseille, France
Pre-medication With N-acetylcysteine and Simethicone to Improve Mucosal Visibility During Gastroduodenoscopy	2023/07/19	NCT05951712	Not Applicable	Completed	Asian Institute of Gastroenterology, India
Efficacy and Safety of Mebeverine + Simethicone in Patients With Functional Bowel Disorders	2022/01/03	NCT05175131	Phase 3	Completed	Abbott
The Impact of Air Travel on Passenger Cognitive Functions	2021/03/17	NCT04802785	Phase 2	UNKNOWN	Dinara Zhumanbayeva
Low-volume vs High-volume Polyethylene Glycol Based Bowel Preparation for Colonoscopy in People Receiving Hemodialysis	2021/01/14	NCT04709770	Phase 4	UNKNOWN	Alfredo Di Leo
Effects of Multilac Baby on Fecal Calprotectin Levels of Colicky Babies	2020/12/14	NCT04666324	Not Applicable	UNKNOWN	The President Stanisław Wojciechowski State University of Applied Sciences in Kalisz
Effects of Vivatlac Baby on Crying Behavior of Colicky Babies	2020/07/27	NCT04487834	Phase 2	Completed	The President Stanisław Wojciechowski State University of Applied Sciences in Kalisz
A Study of Combination Caplet With Loperamide Hydrochloride and Simethicone, and Imodium Express Tablets-lyophilizate Coadministered With Espumisan Capsule in Healthy Volunteers	2019/12/05	NCT04186936	Phase 1	Completed	McNeil AB

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	XEPA-SOUL PATTINSON (MALAYSIA) SDN BHD	SIN03333P	SYRUP	50 mg/5 ml	6/16/1989
CENVITE TABLET	SUNWARD PHARMACEUTICAL PRIVATE LIMITED	SIN07046P	TABLET	30 mg	6/5/1992
E-Z-GAS II GRANULES	Tower Laboratories	SIN06442P	GRANULE	0.04 g/4 g	7/11/1991
ACOLIC SYRUP	Royce Pharma Manufacturing Sdn Bhd	SIN10344P	SYRUP	50 mg/5 ml	11/4/1998
ALUMAG PLUS TABLETS	BEACONS PHARMACEUTICALS PTE LTD	SIN03547P	TABLET	30 mg	6/6/1989
MYLOM DROPS 40 mg/0.6 ml	OLIC (THAILAND) LTD	SIN02382P	SOLUTION	40 mg/0.6 ml	11/9/1988
RIDWIND BABY DROP	ICM PHARMA PTE. LTD.	SIN09136P	EMULSION	100 mg/ml	1/16/1997
AXCEL EVILINE TABLET	KOTRA PHARMA (M) SDN BHD	SIN06592P	TABLET	20 mg	9/26/1991
SIMCONE CHEWABLE TABLET 80 mg	T O PHARMA CO LTD	SIN11621P	TABLET	80 mg	8/10/2001
POLYSILIC III SUSPENSION	BEACONS PHARMACEUTICALS PTE LTD	SIN03406P	SUSPENSION	30 mg/5 ml	6/16/1989

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
VIDA-MECO SUSP ORAL	N/A	MARCHING PHARMACEUTICAL LIMITED	N/A	N/A	2/6/1987
BAROS EFFERVESCENT GRANULES	N/A	EISAI (HONG KONG) COMPANY LIMITED	N/A	N/A	9/6/1988
ALBISTA CAPSULES	N/A	LSB (HK) LIMITED	N/A	N/A	11/6/2024
SIMWELL CHEWABLE TABLETS	N/A	HITPHARM PHARMACEUTICAL COMPANY LIMITED	N/A	N/A	11/6/2017
GASEDIN-U EXTRA STOMACH CHEWABLE TAB	N/A	ADVANCE PHARMACEUTICAL COMPANY LIMITED	N/A	N/A	12/28/2006
MAALOX PLUS TAB	N/A	SUNSTONE CHINA LIMITED	N/A	N/A	10/12/1978
SIGAS TABLET 80MG	N/A	Natural Health Resources Company Limited	N/A	N/A	3/27/2014
FEDRA-GEL-S CHEWABLE TAB	N/A	MARCHING PHARMACEUTICAL LIMITED	N/A	N/A	7/4/1984
WEICHI TAB	N/A	WILCOME PHARMACEUTICAL COMPANY LIMITED	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	Key Pharmaceuticals Pty Ltd	Medicine	A	10/31/2001
GAS-MED simethicone 200mg soft gelatin capsules blister pack	444752	Nova Pharmaceuticals Australasia Pty Ltd	Medicine	A	3/27/2024
APOHEALTH DIARRHOEA RELIEF PLUS chewable tablet blister pack	235981	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	4/9/2015
MYLANTA 2go ANTACID ORIGINAL chewable tablet (reformulation) blister pack	118511	Johnson & Johnson Pacific Pty Ltd	Medicine	A	5/11/2005
COLES GAS RELIEF simethicone 200mg soft gelatin capsules blister pack	491326	Nova Pharmaceuticals Australasia Pty Ltd	Medicine	A	6/10/2025
CHEMISTS’ OWN DIARRHOEA RELIEF PLUS chewable tablet blister pack	238207	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	5/18/2015
DE-GAS simethicone 100mg capsule blister pack	10395	Haleon Australia Pty Ltd	Medicine	A	7/4/1991
MYLANTA DOUBLE STRENGTH oral liquid bottle (reformulation 2)	126090	Johnson & Johnson Pacific Pty Ltd	Medicine	A	3/10/2006
MYLANTA ANTACID DOUBLE STRENGTH oral liquid bottle	294406	Johnson & Johnson Pacific Pty Ltd	Medicine	A	9/27/2017
MYLANTA P ANTACID oral liquid bottle (reformulation)	121994	Johnson & Johnson Pacific Pty Ltd	Medicine	A	9/19/2005

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
VIVASCON EXTRA STRENGTH	Viva Pharmaceutical Inc.	02436922	Tablet - Oral	125 MG	N/A
OVOL FOR GAS 80 MG TABLET	church & dwight canada corp	00292990	Tablet - Oral	80 MG	12/31/1974
GAS RELIEF LIQUID GELS	Catalent Ontario Limited	02492288	Capsule - Oral	125 MG	N/A
EXTRA STRENGTH GAS RELIEF LIQUID GELS	Catalent Ontario Limited	02492296	Capsule - Oral	180 MG	N/A
ULTRA STRENGTH GAS RELIEF	the shandex sales group limited	02483114	Capsule - Oral	180 MG	N/A
SIMETHICONE 180 MG SOFTGEL CAPSULES	cellchem pharmaceuticals inc.	02548011	Capsule - Oral	180 MG	N/A
PEDIACOL	euro-pharm international canada inc	02245510	Drops - Oral	40 MG / ML	5/21/2004
GELUSIL ANTACID AND ANTI-GAS	Pharmascience Inc	02409836	Tablet (Chewable) - Oral	25 MG	1/14/2014
MAALOX PLUS SUSPENSION EXTRA STRENGTH	novartis consumer health canada inc.	02162342	Suspension - Oral	8 MG / ML	7/30/1996
EXTRA STRENGTH GAS RELIEF	essentia healthcare (canada) limited	02247764	Capsule - Oral	166.0 MG	6/16/2003

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
ENTERO SILICONA 9 mg/ml EMULSION ORAL	Laboratorio Estedi S.L.	38426	EMULSIÓN ORAL	Sin Receta	Commercialized
FORTASEC PLUS 2 mg/ 125 mg COMPRIMIDOS	Jntl Consumer Health (Spain) S.L.	69021	COMPRIMIDO	Sin Receta	Commercialized
AERO-RED GOTAS ORALES	Uriach Consumer Healthcare S.L.	39560	GOTAS ORALES EN SOLUCIÓN	Sin Receta	Not Commercialized
DISOLGAS 257,5 mg CAPSULAS BLANDAS.	Arkopharma Laboratorios S.A.U.	64567	CÁPSULA DURA	Sin Receta	Commercialized
NORAFLAT 40 MG COMPRIMIDOS MASTICABLES	Laboratorios Normon S.A.	79469	COMPRIMIDO MASTICABLE	Sin Receta	Commercialized
AERO RED 120 mg COMPRIMIDOS MASTICABLES SABOR MENTA	Uriach Consumer Healthcare S.L.	72263	COMPRIMIDO MASTICABLE	Sin Receta	Not Commercialized
FLATORIL 500 microgramos/200 mg CAPSULAS DURAS	Almirall S.A.	56078	CÁPSULA DURA	Medicamento Sujeto A Prescripción Médica	Commercialized
FLATORIL 100 microgramos/ml + 40 mg/ml EMULSION ORAL	Almirall S.A.	56244	EMULSIÓN ORAL	Medicamento Sujeto A Prescripción Médica	Not Commercialized
CLENSIA POLVO PARA SOLUCION ORAL	Alfasigma España, S.L.	81575	POLVO PARA SOLUCIÓN ORAL	Medicamento Sujeto A Prescripción Médica	Commercialized
IMONOGAS 240 mg CAPSULAS BLANDAS	Jntl Consumer Health (Spain) S.L.	68549	CÁPSULA BLANDA	Sin Receta	Not Commercialized

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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