Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID 0d8fe3d5-1e5e-152e-98e0-bc9cea139ba6
Route
ORAL
Published
Effective Date 2020-05-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dimethicone (250 mg)
Inactive Ingredients
D&c Red No. 33 Water Gelatin, Unspecified Fd&c Blue No. 1 Glycerin Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Shape: capsule Color: purple Size: 11 mm Score: 1
Marketing Status
OTC MONOGRAPH FINAL Active Since 2019-11-18
Description

(in each softgel) Simethicone 250mg

Purpose

Anti-gas

Medication Information

Purpose

Anti-gas

Description

(in each softgel) Simethicone 250mg

Use

For the relief of

  • Pressure, bloating or fullness commonly referred to as gas
Directions
  • Adults and children 12 years and older; swallow with water 1 or 2 softgels as needed after meals and at bedtime.
  • Do not exceed 2 softgels in 24 hours except under the advice and supervision of a physician
Active Ingredient

(in each softgel)

Simethicone 250mg

Other Information
  • store at room temperature 20ºC to 35ºC (68ºF to 77ºF)
Inactive Ingredients

DC Red # 33, FD&C Blue No. 1, Gelatin, Glycerin, purified water, titanium dioxide

Questions Or Comments?

Call toll-free 1-800-706-5575

Principal Display Panel

CVS Maximum Strength

Gas Relief

Simethicone 250 mg (anti-gas)

36 Liquid Filled Softgels

Blister Carton label

NDC# 69842-772-03

Simethicone Maximum Strength Softgels  are concentrated to contain liquid gas-fighting medicine in a small softgel so they are easy to swallow, and there is no chalky taste.

Structured Label Content

Use

For the relief of

  • Pressure, bloating or fullness commonly referred to as gas
Purpose

Anti-gas

Directions
  • Adults and children 12 years and older; swallow with water 1 or 2 softgels as needed after meals and at bedtime.
  • Do not exceed 2 softgels in 24 hours except under the advice and supervision of a physician
Active Ingredient

(in each softgel)

Simethicone 250mg

Other Information
  • store at room temperature 20ºC to 35ºC (68ºF to 77ºF)
Inactive Ingredients

DC Red # 33, FD&C Blue No. 1, Gelatin, Glycerin, purified water, titanium dioxide

Questions Or Comments? (Questions or comments?)

Call toll-free 1-800-706-5575

Principal Display Panel

CVS Maximum Strength

Gas Relief

Simethicone 250 mg (anti-gas)

36 Liquid Filled Softgels

Blister Carton label

NDC# 69842-772-03

Simethicone Maximum Strength Softgels  are concentrated to contain liquid gas-fighting medicine in a small softgel so they are easy to swallow, and there is no chalky taste.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:00:23.619658 · Updated: 2026-03-14T23:00:47.249871