Gas Relief Simethicone 125 Mg Softgels

Gas Relief Simethicone 125 Mg Softgels
SPL v1
SPL
SPL Set ID 21e11fe0-b3b9-42f6-a698-9cdc1a6d82bb
Route
ORAL
Published
Effective Date 2025-04-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-04-23
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 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 30ºC (59 to 86ºF)
  • protect from light, heat, and moisture
Inactive Ingredients 

Refined Soyabean Oil, Gelatin, Glycerin, Sorbitol solution, Titanium dioxide, FD&C lue No 1, D&C Yellow 10, Purified water.

Questions Or Comments?

Call + 1 (732) 994-2808 or email [email protected]

Keep Out of Reach of Children.

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 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 30ºC (59 to 86ºF)
  • protect from light, heat, and moisture
Inactive Ingredients 

Refined Soyabean Oil, Gelatin, Glycerin, Sorbitol solution, Titanium dioxide, FD&C lue No 1, D&C Yellow 10, Purified water.

Questions Or Comments? (Questions or Comments?)

Call + 1 (732) 994-2808 or email [email protected]

Keep Out of Reach of Children. (KEEP OUT OF REACH OF CHILDREN.)

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: 2026-02-15T12:05:58.670392 · Updated: 2026-03-14T23:08:25.015175