Simethicone tablet

Form: Tablets

Strength: 40 mg

Reference Brands: Mylicon(US)

Category: Gastrointestinal Drugs

Simethicone chewable tablets, marketed as Mylicon in the US and as generic formulations in the EU, are approved as over-the-counter products for relief of gas, bloating, and indigestion. Regulatory approval requires a dossier including safety profiles, manufacturing standards, and labeling compliance. In the US, the FDA oversees OTC safety, while the EMA ensures safety and quality in Europe. For guidance on dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Proper compliance supports timely approval, safe use, and broad availability, helping consumers worldwide manage gastrointestinal discomfort effectively.