FDA.reportPublic FDA data

Gas Relief

Manufacturer
H-E-B | TIME CAP LABS INC | MARKSANS PHARMA LIMITED
Effective date
2025-12-24
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:31:13

Label at a glance#

ProductGas Relief
Active ingredientDIMETHICONE
Label structure11 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

Anti-gas

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 SImethicone 125mg softgels 30ct

HEB 722T 30ctHEB 722T 30ct

722T Simethicone 125mg softgels 200ct

HEB 722T 200ctHEB 722T 200ct

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
37808-744-20Gas Relief200 in 1 BOTTLECAPSULE2002
37808-744-30Gas Relief2 in 1 CARTONCAPSULE22
37808-744-30Gas Relief15 in 1 BLISTER PACKCAPSULE152

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
37808-74437808-744-30, 37808-744-20

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

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 ReliefSIMETHICONEH-E-B3f9f6560-312f-44b7-e063-6394a90a1c562025-12-24WarningsExact identifier
ndc (package): 37808-744-20
ndc (package): 37808-744-30
ndc (product): 37808-744
ndc11 (package): 37808074420
ndc11 (package): 37808074430
spl id: 46ad2019-efba-c0e8-e063-6294a90a46e6
spl set id: 3f9f6560-312f-44b7-e063-6394a90a1c56

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.