SPL v1
SPL
SPL Set ID 9889575e-6ea3-437a-99e9-f6fe8bcecf25
Route
ORAL
Published
Effective Date 2025-06-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dimethicone (125 mg)
Inactive Ingredients
Peppermint Oil Gelatin Water Polysorbate 20 Glycerin Fd&c Blue No. 1 Titanium Dioxide D&c Yellow No. 10

Identifiers & Packaging

Pill Appearance
Imprint: 911 Shape: oval Color: green Size: 10 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-04-01
Description

Simethicone 125 mg

Purpose

Antigas

Medication Information

Purpose

Antigas

Description

Simethicone 125 mg

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
Questions?

Call toll-free 1-844-912-4012

Other Information
  • store at 20° to 25°C (68° to 776°F)
  • protect from light, heat, and moisture
Inactive Ingredients

D&C Yellow 10, edible ink, FD&C blue 1, gelatin, glycerin, peppermint oil, polysorb,  purified water, titanium dioxide.

Active Ingredient (in Each Softgel)

Simethicone 125 mg

Structured Label Content

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
Questions?

Call toll-free 1-844-912-4012

Other Information
  • store at 20° to 25°C (68° to 776°F)
  • protect from light, heat, and moisture
Inactive Ingredients

D&C Yellow 10, edible ink, FD&C blue 1, gelatin, glycerin, peppermint oil, polysorb,  purified water, titanium dioxide.

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

Simethicone 125 mg

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:15.178368 · Updated: 2026-03-14T23:08:54.445441