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

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

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 55106-9

Active ingredient (in each softgel)

Simethicone USP 125 mg

Section 60561-8

Other information

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

Structured Label Content

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
Warnings and Precautions (34071-1)

Warning

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 55106-9 (55106-9)

Active ingredient (in each softgel)

Simethicone USP 125 mg

Section 60561-8 (60561-8)

Other information

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

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