simethicone 125mg gas relief

simethicone 125mg gas relief
SPL v1
SPL
SPL Set ID 0df348bf-5a07-4f36-ae70-ca2961a9ce7e
Route
oral
Published
Effective Date 2024-09-25
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 fd&c red no. 40 gelatin glycerin povidone peppermint oil water sorbitol titanium dioxide

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2024-09-11
Description

Active Ingredients (in each softgel) Simethicone 125 mg

Medication Information

Active Ingredient

Active Ingredients (in each softgel)

Simethicone 125 mg

Indications and Usage

Use for the relief of

  • pressure
  • bloating
  • 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
Other Information
  • store at controlled room temperature 20°-25°C (68°-77°F)
  • protact from light, heat and moisture
  • do not use if imprinted safety seal under cap is broken or missing
Description

Active Ingredients (in each softgel) Simethicone 125 mg

Section 51727-6

D&C yellow 10, FD&C blue 1, FD&C red 40, gelatin, glycerin, povidone, peppermint oil, purified water, sorbitol, titanium dioxide

Section 51945-4

Section 53413-1

Questions or comments?

Call 1-833-663-2933

Section 55105-1

Purpose

Antigas

Warning

Drug Facts

Keep Out of Reach of Children

Structured Label Content

Active Ingredient (55106-9)

Active Ingredients (in each softgel)

Simethicone 125 mg

Indications and Usage (34067-9)

Use for the relief of

  • pressure
  • bloating
  • 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
Other Information
  • store at controlled room temperature 20°-25°C (68°-77°F)
  • protact from light, heat and moisture
  • do not use if imprinted safety seal under cap is broken or missing
Section 51727-6 (51727-6)

D&C yellow 10, FD&C blue 1, FD&C red 40, gelatin, glycerin, povidone, peppermint oil, purified water, sorbitol, titanium dioxide

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments?

Call 1-833-663-2933

Section 55105-1 (55105-1)

Purpose

Antigas

Warning

Drug Facts

Keep Out of Reach of Children (Keep out of reach of children)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:38.309626 · Updated: 2026-03-14T23:03:49.531028