simethicone capsules usp, 250 mg

simethicone capsules usp, 250 mg
SPL v3
SPL
SPL Set ID 322e6cb3-0ddc-9300-e063-6294a90a972a
Route
oral
Published
Effective Date 2025-10-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
dimethicone (250 mg)
Inactive Ingredients
water gelatin d&c red no. 33 fd&c blue no. 1 glycerin silicon dioxide

Identifiers & Packaging

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

Active ingredient (in each softgel) Simethicone USP 250 mg

Medication Information

Warnings and Precautions

Warnings

Active Ingredient

Active ingredient (in each softgel)

Simethicone USP 250 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 2 softgels in 24 hours except under the advice and supervision of a physician

Description

Active ingredient (in each softgel) Simethicone USP 250 mg

Principal Display Panel

NDC 35916-1940-2

Compare to Gas-X ® Maximum Strength Active Ingredient*

Simethicone Capsules USP, 250 mg

Simethicone 250 mg / Antigas (Relieves Gas Fast)

RELIEVES GAS FAST:

  • Pressure
  • Bloating
  • Discomfort

50 Softgels

Section 50565-1

Keep out of reach of children.

Section 51727-6

Inactive ingredients

D&C red no.33, FD&C blue no.1, gelatin, glycerin, purified water

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)

Warnings

Active Ingredient (55106-9)

Active ingredient (in each softgel)

Simethicone USP 250 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 2 softgels in 24 hours except under the advice and supervision of a physician

Principal Display Panel

NDC 35916-1940-2

Compare to Gas-X ® Maximum Strength Active Ingredient*

Simethicone Capsules USP, 250 mg

Simethicone 250 mg / Antigas (Relieves Gas Fast)

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

D&C red no.33, FD&C blue no.1, gelatin, glycerin, purified water

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: 2026-02-15T12:08:23.679612 · Updated: 2026-03-14T23:12:38.341862