simethicone capsules usp, 180 mg

simethicone capsules usp, 180 mg
SPL v3
SPL
SPL Set ID 3205339a-3914-4e25-e063-6394a90a07cd
Route
oral
Published
Effective Date 2025-10-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
dimethicone (180 mg)
Inactive Ingredients
sorbitol titanium dioxide water fd&c yellow no. 6 peppermint oil gelatin glycerin silicon dioxide

Identifiers & Packaging

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

Active ingredient (in each softgel) Simethicone USP 180 mg

Medication Information

Warnings and Precautions

Warnings

Active Ingredient

Active ingredient (in each softgel)

Simethicone USP 180 mg

Indications and Usage

Use

for the relief of

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

Directions

  • adults: swallow with water 1 or 2 softgels as needed after meals and at bedtime
  • do not exceed 2 softgels in 24 hours except under the advice and supervision of a physician
Description

Active ingredient (in each softgel) Simethicone USP 180 mg

Principal Display Panel

NDC 35916-1939-2

Compare to Gas-X ® Ultra Strength Active Ingredient*

Simethicone Capsules USP, 180 mg

Simethicone 180 mg / Antigas

RELIEVES GAS FAST:

  • Pressure
  • Bloating
  • Discomfort

50 Softgels

Section 50565-1

Keep out of reach of children.

Section 51727-6

Inactive ingredients

FD&C yellow no.6, gelatin, glycerin, peppermint oil, purified water, sorbitol, titanium dioxide

Section 55105-1

Purpose

Antigas

Section 60561-8

Other information

  • store at controlled room temperature 20-25ºC (68-77ºF)
  • protect from moisture
  • read all product information before using.
  • Keep this box for important information

Structured Label Content

Warnings and Precautions (34071-1)

Warnings

Active Ingredient (55106-9)

Active ingredient (in each softgel)

Simethicone USP 180 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: swallow with water 1 or 2 softgels as needed after meals and at bedtime
  • do not exceed 2 softgels in 24 hours except under the advice and supervision of a physician
Principal Display Panel

NDC 35916-1939-2

Compare to Gas-X ® Ultra Strength Active Ingredient*

Simethicone Capsules USP, 180 mg

Simethicone 180 mg / Antigas

RELIEVES GAS FAST:

  • Pressure
  • Bloating
  • Discomfort

50 Softgels

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 51727-6 (51727-6)

Inactive ingredients

FD&C yellow no.6, gelatin, glycerin, peppermint oil, purified water, sorbitol, 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 moisture
  • read all product information before using.
  • Keep this box for important information

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:12.440480 · Updated: 2026-03-14T23:12:38.341862