434 - Gas Relief

434 - Gas Relief
SPL v4
SPL
SPL Set ID ae98861e-6a26-4e0e-a66a-b2738d3cbddd
Route
ORAL
Published
Effective Date 2021-09-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Imprint: PC31 Shape: oval Color: purple Size: 13 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2016-01-11
Description

Simethicone 250 mg

Purpose

Anti-gas

Medication Information

Purpose

Anti-gas

Description

Simethicone 250 mg

Use(s)

Relieves bloating, pressure or fullness commonly referred to as gas

Questions

Call 1-888-952-0050 Monday through Friday 9AM - 5PM

Directions
  • Swallow 1 or 2 softgels as symptoms occur
  • Do not exceed 2 softgels in 24 hours except under the advice and supervision of a physician.

Other Information
  • store at room temperature (59°– 86°F) 15°– 30°C
  • do not use if imprinted safety seal under cap is broken or missing

Active Ingredient(s)

Simethicone 250 mg

Inactive Ingredients

D&C red #33, FD&C blue #1, gelatin, glycerin, purified water and white edible ink

Principal Display Panel
Gas Relief
Stop Use and Ask A Doctor If

condition persists

Structured Label Content

Use(s)

Relieves bloating, pressure or fullness commonly referred to as gas

Purpose

Anti-gas

Questions

Call 1-888-952-0050 Monday through Friday 9AM - 5PM

Directions
  • Swallow 1 or 2 softgels as symptoms occur
  • Do not exceed 2 softgels in 24 hours except under the advice and supervision of a physician.

Other Information (Other information)
  • store at room temperature (59°– 86°F) 15°– 30°C
  • do not use if imprinted safety seal under cap is broken or missing

Active Ingredient(s) (Active ingredient(s))

Simethicone 250 mg

Inactive Ingredients (Inactive ingredients)

D&C red #33, FD&C blue #1, gelatin, glycerin, purified water and white edible ink

Principal Display Panel
Gas Relief
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

condition persists

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:39.359555 · Updated: 2026-03-14T23:05:32.543899