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

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

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 55106-9

Active ingredient (in each softgel)

Simethicone USP 180 mg

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
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

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: 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
Warnings and Precautions (34071-1)

Warnings

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 55106-9 (55106-9)

Active ingredient (in each softgel)

Simethicone USP 180 mg

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
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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

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