Bjs Simethicone Soft Gelatin Capsules 125 Mg

Bjs Simethicone Soft Gelatin Capsules 125 Mg
SPL v2
SPL
SPL Set ID 2f32dde8-502e-eefa-e063-6294a90abf20
Route
ORAL
Published
Effective Date 2025-08-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dimethicone (125 mg)
Inactive Ingredients
Fd&c Red No. 40 Glycerin Titanium Dioxide Sorbitol Solution Water Medium-chain Triglycerides D&c Yellow No. 10 Gelatin, Unspecified Sorbitan Shellac Fd&c Blue No. 1 Propylene Glycol Peppermint Oil

Identifiers & Packaging

Pill Appearance
Imprint: 105 Shape: oval Color: green Size: 10 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-08-20

Description

Drug Facts


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

Drug Facts

Section 42229-5

Drug Facts

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

722T 240ct label

722T 240ct Carton

Section 53413-1

Questions or comments? Call 1-877-290-4008

Section 55105-1

Purpose

Antigas

Section 55106-9

Active ingredient (in each softgel)

Simethicone 125 mg

Section 60561-8

Other information

  • store at room temperature
  • protect from light, heat and moisture

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 42229-5 (42229-5)

Drug Facts

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)

722T 240ct label

722T 240ct Carton

Section 53413-1 (53413-1)

Questions or comments? Call 1-877-290-4008

Section 55105-1 (55105-1)

Purpose

Antigas

Section 55106-9 (55106-9)

Active ingredient (in each softgel)

Simethicone 125 mg

Section 60561-8 (60561-8)

Other information

  • store at room temperature
  • protect from light, heat and moisture

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)