FDA.reportPublic FDA data

BJs Simethicone Soft Gelatin Capsules 125 mg

Manufacturer
BJWC (Berkley & Jensen / BJ's) | TIME CAP LABORATORIES, INC. | MARKSANS PHARMA LIMITED
Effective date
2025-08-19
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:12:17

Label at a glance#

ProductGas Relief
Active ingredientDIMETHICONE
Label structure10 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each softgel)

Simethicone 125 mg

OTC - PURPOSE SECTION

Purpose

Antigas

INDICATIONS & USAGE SECTION

Use for the relief of

  • pressure, bloating and fullness commonly referred to as gas

WARNINGS SECTION

Warning

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

DOSAGE & ADMINISTRATION SECTION

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

OTHER SAFETY INFORMATION

Other information

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

INACTIVE INGREDIENT SECTION

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

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

722T 240ct label

722T- BJ- Gas Reilef 240ct label722T- BJ- Gas Reilef 240ct label

722T 240ct Carton

722T- BJ- Gas Reilef 240ct carton722T- BJ- Gas Reilef 240ct carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198852simethicone 125 MG Oral CapsulePSN2
198852simethicone 125 MG Oral CapsuleSCD2
198852dimethicone 125 MG Oral CapsuleSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIMETHICONE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68391-722-29Gas Relief1 in 1 CARTONCAPSULE12
68391-722-29Gas Relief240 in 1 BOTTLECAPSULE2402

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68391-72268391-722-29

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
FD&C RED NO. 40WZB9127XOAIACT
GLYCERINPDC6A3C0OXIACT
DIMETHICONE92RU3N3Y1OACTIB
TITANIUM DIOXIDE15FIX9V2JPIACT
SORBITOL SOLUTION8KW3E207O2IACT
WATER059QF0KO0RIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
D&C YELLOW NO. 1035SW5USQ3GIACT
GELATIN, UNSPECIFIED2G86QN327LIACT
SORBITAN6O92ICV9RUIACT
SHELLAC46N107B71OIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PEPPERMINT OILAV092KU4JHIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Gas ReliefSIMETHICONEBJWC (Berkley & Jensen / BJ's)2f32dde8-502e-eefa-e063-6294a90abf202025-08-19WarningsExact identifier
ndc (package): 68391-722-29
ndc (product): 68391-722
ndc11 (package): 68391072229
spl id: 3c1176c2-357a-583d-e063-6394a90a94e4
spl set id: 2f32dde8-502e-eefa-e063-6294a90abf20