722t target 11673-495 simethicone 125 mg softgels

722t target 11673-495 simethicone 125 mg softgels
SPL v3
SPL
SPL Set ID f6ff3b61-8a47-14ec-e053-6294a90a2df8
Route
oral
Published
Effective Date 2025-01-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
dimethicone (125 mg)
Inactive Ingredients
medium-chain triglycerides fd&c red no. 40 peppermint oil sorbitol titanium dioxide fd&c blue no. 1 gelatin glycerin d&c yellow no. 10 water shellac sorbitan propylene glycol

Identifiers & Packaging

Pill Appearance
Imprint: 105 Shape: oval Color: green Size: 10 mm Score: 1
Marketing Status
otc monograph drug active Since 2023-07-01
Description

Active ingredient (in each softgel) Simethicone 125 mg

Medication Information

Warnings and Precautions

Warning

Active Ingredient

Active ingredient (in each softgel)

Simethicone 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 125 mg

Section 44425-7

Other information

  • store at room temperature
  • protect from light, heat and moisture
Section 50565-1

Keep out of reach of children.

Section 51727-6

Inactive ingredients

D&C Yellow #10, FD&C Blue 1, FD&C Red #40, gelatin, glycerol, medium chain triglyceride, peppermint oil, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide

Section 51945-4

Section 53413-1

Questions or comments? Call 1-800-910-6874

Section 55105-1

Purpose

Anti-gas

Structured Label Content

Warnings and Precautions (34071-1)

Warning

Active Ingredient (55106-9)

Active ingredient (in each softgel)

Simethicone 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
Section 44425-7 (44425-7)

Other information

  • store at room temperature
  • protect from light, heat and moisture
Section 50565-1 (50565-1)

Keep out of reach of children.

Section 51727-6 (51727-6)

Inactive ingredients

D&C Yellow #10, FD&C Blue 1, FD&C Red #40, gelatin, glycerol, medium chain triglyceride, peppermint oil, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments? Call 1-800-910-6874

Section 55105-1 (55105-1)

Purpose

Anti-gas

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:05:33.257438 · Updated: 2026-03-14T23:07:31.529158