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

Indications and Usage

Use for the relief of

  • pressure
  • bloating
  • fullness
  • commonly referred to as gas
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

Section 55106-9

Active Ingredients (in each softgel)

Simethicone 125 mg

Warning

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
Drug Facts

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
Keep Out of Reach of Children

Structured Label Content

Indications and Usage (34067-9)

Use for the relief of

  • pressure
  • bloating
  • fullness
  • commonly referred to as gas
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

Section 55106-9 (55106-9)

Active Ingredients (in each softgel)

Simethicone 125 mg

Warning

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
Drug Facts

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
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