728t Target 11673-827 Simethicone 250 Mg Capsules

728t Target 11673-827 Simethicone 250 Mg Capsules
SPL v3
SPL
SPL Set ID f6ff50f5-4195-a61f-e053-6294a90a8bdf
Route
ORAL
Published
Effective Date 2023-08-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dimethicone (250 mg)
Inactive Ingredients
Sorbitan Titanium Dioxide Propylene Glycol Water Fd&c Blue No. 1 Medium-chain Triglycerides Shellac D&c Red No. 33 Gelatin Glycerin Sorbitol

Identifiers & Packaging

Pill Appearance
Imprint: 119 Shape: oval Color: purple Size: 12 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-08-23
Description

Active ingredient (in each softgel) Simethicone 250 mg

Medication Information

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 250 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 red no. 33, FD&C blue 1, gelatin, glycerol, medium chain triglyceride, 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

Antigas

Section 55106-9

Active ingredient (in each softgel)

Simethicone 250 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 2 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 red no. 33, FD&C blue 1, gelatin, glycerol, medium chain triglyceride, 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

Antigas

Section 55106-9 (55106-9)

Active ingredient (in each softgel)

Simethicone 250 mg

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:07.041423 · Updated: 2026-03-14T23:02:58.626725