Simethicone
Active ingredient
Sold as Gas Relief · INFACOL · PEDIACOL · Leader Gas relief · PUBLIX Extra Strength
- Drug class
- -
- Availability
- Over-the-counter
- Routes
- Oral
- Markets covered
- 3
- Products on record
- 53
- FDA reports (12 mo)
- 355
Overview
Plain-language summary, compiled from the cited regulatory records
Simethicone is an over-the-counter medication used for the relief of pressure and bloating commonly referred to as gas [1]. It is available under various brand names, including Gas Relief Ultra Strength and Leader Gas relief [1].
In the past 12 months, there have been 355 adverse event reports associated with simethicone [2]. The most frequently reported reactions include fatigue, headache, nausea, diarrhea, and the perception that the drug was ineffective [2].
This is not medical advice. Consult a qualified healthcare professional.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| US United States | FDA | 32 | April 20, 2026 |
| CA Canada | Health Canada | 20 | December 29, 2025 |
| GB United Kingdom | MHRA | 1 | April 10, 2026 |
USUnited States· FDA
32 products
Uses
Uses For the relief of pressure and bloating commonly referred to as gas
How to take
CACanada· Health Canada
20 products
Uses
IMODIUM® Complete (Loperamide Hydrochloride and Simethicone) is indicated: • as an adjunct to rehydration therapy for the symptomatic control of acute, nonspecific diarrhea associated with gas-related abdominal discomfort, such as distention, bloating, flatulence, abdominal pain and cramping.
Treatment of diarrhea with IMODIUM® Complete is only symptomatic. Whenever an underlying etiology can be determined, specific treatment should be given when appropriate (or when indicated). 1 Pediatrics Pediatrics (<12 years of age): The use of Loperamide hydrochloride/Simethicone is not recommended for children under 12 years of age except on the advice of a physician.
Loperamide hydrochloride/Simethicone should not be given to children under 6 years of age without medical prescription and supervision. Loperamide hydrochloride/Simethicone is contraindicated for use in children under 2 years of age.
2 Geriatrics No dose adjustments are required for the elderly.
GBUnited Kingdom· MHRA
1 product
Uses
For the effective relief of acid indigestion, nervous indigestion, heartburn, upset stomach, uncomfortable bloating, biliousness, flatulence, painful trapped wind, and indigestion and heartburn during pregnancy.
How to take
Drug interactions
Known interactions involving Simethicone. Select one for details. This list is informational and not a complete interaction checker.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
Sources & citations
- [1]FDA DailyMed · 0050b639-5fb6-45… · revised June 26, 2024 [PDF]
- [2]Health Canada (DPD) · 02245185 · revised December 29, 2025
- [3]MHRA (UK) · PL000100350 · revised April 10, 2026
- [4]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.