Assured Gas Relief Drug Facts

Assured Gas Relief Drug Facts
SPL v1
SPL
SPL Set ID d5b412b4-9121-42e0-8c3f-413810ade6dd
Route
ORAL
Published
Effective Date 2009-07-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Imprint: R113 Shape: oval Color: green Size: 10 mm Score: 1
Marketing Status
OTC MONOGRAPH FINAL Active Since 2012-01-06
Description

Simethicone 125 mg

Purpose

Antigas

Medication Information

Purpose

Antigas

Description

Simethicone 125 mg

Uses

for the relief of

  • pressure, bloating, and fullness commonly referred to as gas
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
  • do not use if any individual blister unit is broken or missing
Other Information
  • store at controlled room temperature 20°-25°C (68-77°F)
  • protect from light, heat and moisture
Inactive Ingredients

D&C yellow 10, FD&C blue 1, gelatin, glycerin, purified water, titanium dioxide

Principal Display Panel

Compare to active ingredient in Extra Strength Gas-X®

Extra Strength

Gas Relief

Simethicone 125 mg

Anti-Gas

Relieves:

Bloating, Pressure, Fullness, Gas

15 Softgels

Assured Gas Relief Extra Strength
Active Ingredient (in Each Softgel)

Simethicone 125 mg

Structured Label Content

Uses

for the relief of

  • pressure, bloating, and fullness commonly referred to as gas
Purpose

Antigas

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
  • do not use if any individual blister unit is broken or missing
Other Information (Other information)
  • store at controlled room temperature 20°-25°C (68-77°F)
  • protect from light, heat and moisture
Inactive Ingredients (Inactive ingredients)

D&C yellow 10, FD&C blue 1, gelatin, glycerin, purified water, titanium dioxide

Principal Display Panel

Compare to active ingredient in Extra Strength Gas-X®

Extra Strength

Gas Relief

Simethicone 125 mg

Anti-Gas

Relieves:

Bloating, Pressure, Fullness, Gas

15 Softgels

Assured Gas Relief Extra Strength
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: 2026-02-15T11:55:42.092346 · Updated: 2026-03-14T22:53:35.925326