simethicone capsules usp, 125 mg

simethicone capsules usp, 125 mg
SPL v3
SPL
SPL Set ID 32018302-7ce5-1f15-e063-6394a90ad378
Route
oral
Published
Effective Date 2026-01-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
dimethicone (125 mg)
Inactive Ingredients
d&c yellow no. 10 titanium dioxide gelatin peppermint oil sorbitol fd&c blue no. 1 glycerin water fd&c red no. 40

Identifiers & Packaging

Pill Appearance
Shape: oval Color: green Size: 11 mm Score: 1
Marketing Status
otc monograph drug active Since 2025-10-28
Description

Active ingredient (in each softgel) Simethicone USP 125 mg

Medication Information

Warnings and Precautions

Warning

Active Ingredient

Active ingredient (in each softgel)

Simethicone USP 125 mg

Indications and Usage

Use

for the relief of

  • pressure, bloating, and fullness commonly referred to as gas
Dosage and Administration

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 4 softgels in 24 hours except under the advice and supervision of a physician
Description

Active ingredient (in each softgel) Simethicone USP 125 mg

Principal Display Panel

Compare to Gas-X ® Extra Strength Active Ingredient*

NDC 35916-1938-2

Simethicone Capsules USP, 125 mg

Simethicone 125 mg / Antigas (Relieves Gas Fast)

Pressure, Bloating, Discomfort

30 Softgels

Section 50565-1

Keep out of reach of children.

Section 51727-6

Inactive ingredients

D&C yellow no.10, FD&C blue no. 1, FD&C red no.40, gelatin, glycerin, peppermint oil, purified water, sorbitol sorbitan solution, titanium dioxide

Section 55105-1

Purpose

Antigas

Section 60561-8

Other information

  • store at controlled room temperature 20-25ºC (68-77ºF)
  • protect from light, heat, and moisture

Structured Label Content

Warnings and Precautions (34071-1)

Warning

Active Ingredient (55106-9)

Active ingredient (in each softgel)

Simethicone USP 125 mg

Indications and Usage (34067-9)

Use

for the relief of

  • pressure, bloating, and fullness commonly referred to as gas
Dosage and Administration (34068-7)

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 4 softgels in 24 hours except under the advice and supervision of a physician
Principal Display Panel

Compare to Gas-X ® Extra Strength Active Ingredient*

NDC 35916-1938-2

Simethicone Capsules USP, 125 mg

Simethicone 125 mg / Antigas (Relieves Gas Fast)

Pressure, Bloating, Discomfort

30 Softgels

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 51727-6 (51727-6)

Inactive ingredients

D&C yellow no.10, FD&C blue no. 1, FD&C red no.40, gelatin, glycerin, peppermint oil, purified water, sorbitol sorbitan solution, titanium dioxide

Section 55105-1 (55105-1)

Purpose

Antigas

Section 60561-8 (60561-8)

Other information

  • store at controlled room temperature 20-25ºC (68-77ºF)
  • protect from light, heat, and moisture

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:12.439501 · Updated: 2026-03-14T23:12:32.924893