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

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

Section 55106-9

Active ingredient (in each softgel)

Simethicone 125 mg

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 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

Section 55106-9 (55106-9)

Active ingredient (in each softgel)

Simethicone 125 mg

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