Gas Relief Simethicone 125mg Softgel

Gas Relief Simethicone 125mg Softgel
SPL v2
SPL
SPL Set ID b774c8e6-e68e-4a13-834d-7eba34c5c3e0
Route
ORAL
Published
Effective Date 2024-07-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dimethicone (125 mg)
Inactive Ingredients
Peppermint Oil Gelatin Sorbitol Sorbitan Glycerin Fd&c Blue No. 1 Titanium Dioxide D&c Yellow No. 10

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-07-18
Description

Simethicone 125 mg

Purpose

Antigas

Medication Information

Purpose

Antigas

Description

Simethicone 125 mg

Use

Use for the relief of pressure, bloating, and fullness, commonly referred to as gas.

Section 50565-1

KEEP OUT OF REACH OF CHILDREN.

Section 51945-4

Warnings

If pregnant or breast-feeding, ask a health professional before use.

Directions
  • adults: swallow with water 1 or 2 softgels as needed after meals and at bedtime
  • do not exceed 4 softgels in 24 hours except under the advice and supervision of a physician
Other Information
  • store at 15° to 30°C (59° to 86°F)
  • protect from light, heat, and moisture
Inactive Ingredients

Peppermint Oil, Gelatin, Sorbitol,  Sorbitan Anhydrous, Glycerin, FD & C blue 1 (Brilliant Blue FCF), Titanium Dioxide, D & C Yellow 10 (Quinoline Yellow).

Questions Or Comments?

Call 1 (718) 337-8733 or visit [email protected]

Active Ingredient (in Each Softgel)

Simethicone 125 mg

Structured Label Content

Use

Use for the relief of pressure, bloating, and fullness, commonly referred to as gas.

Section 50565-1 (50565-1)

KEEP OUT OF REACH OF CHILDREN.

Section 51945-4 (51945-4)

Purpose

Antigas

Warnings

If pregnant or breast-feeding, ask a health professional before use.

Directions
  • adults: swallow with water 1 or 2 softgels as needed after meals and at bedtime
  • do not exceed 4 softgels in 24 hours except under the advice and supervision of a physician
Other Information
  • store at 15° to 30°C (59° to 86°F)
  • protect from light, heat, and moisture
Inactive Ingredients

Peppermint Oil, Gelatin, Sorbitol,  Sorbitan Anhydrous, Glycerin, FD & C blue 1 (Brilliant Blue FCF), Titanium Dioxide, D & C Yellow 10 (Quinoline Yellow).

Questions Or Comments? (Questions or Comments?)

Call 1 (718) 337-8733 or visit [email protected]

Active Ingredient (in Each Softgel) (Active Ingredient (in each softgel))

Simethicone 125 mg

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:07:49.914468 · Updated: 2026-03-14T23:11:42.520832