FDA.reportPublic FDA data

Gas Relief

Manufacturer
Strategic Sourcing Services LLC
Effective date
2025-11-19
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:16:57

Label at a glance#

ProductGas Relief
Active ingredientDIMETHICONE
Label structure10 sections

Indications and uses

for the relief of pressure, bloating, and fullness commonly referred to as gas

Dosage and administration

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

Storage and handling

store between 20-25°C (68-77°F) do not refrigerate protect from light, heat, and moisture

Label contents#

Full prescribing information#

Active ingredient (in each softgel)

OTC - ACTIVE INGREDIENT SECTION

Simethicone 125 mg

Purpose

OTC - PURPOSE SECTION

Antigas

Uses

INDICATIONS & USAGE SECTION

for the relief of pressure, bloating, and fullness commonly referred to as gas

Warnings

WARNINGS SECTION

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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 information

STORAGE AND HANDLING SECTION

  • store between 20-25°C (68-77°F)
  • do not refrigerate
  • protect from light, heat, and moisture

Inactive ingredients

INACTIVE INGREDIENT SECTION

D&C yellow #10, edible ink, FD&C blue #1, FD&C red #40, gelatin, glycerin, mannitol, peppermint oil, purified water, sorbitan, sorbitol, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-833-358-6431 Monday to Friday 9:00am to 7:00pm EST

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

COMPARE TO GAS-X® EXTRA STRENGTH ACTIVE INGREDIENT*

EXTRA STRENGTH

Gas Relief

Simethicone 125 mg

ANTI-GAS

Relieves Gas Symptoms

Fast fast relief of:

  • Pressure
  • Bloating
  • Discomfort

SOFTGELS

TAMPER EVIDENT: DO NOT USE IF  BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

*This product is not manufactured or distributed by Haleon group of companies, distributor of Gas- X® Extra Strength.

Distributed by: McKesson Corp.,

via Strategic Sourcing Services LLC.

Memphis, TN 38141

www.fosterand thrive.com

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FOSTER & THRIVE Extra Strength Gas Relief
FOSTER & THRIVE Extra Strength Gas Relief

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198852simethicone 125 MG Oral CapsulePSN4
198852simethicone 125 MG Oral CapsuleSCD4
198852dimethicone 125 MG Oral CapsuleSY4

DailyMed Pharmacologic Classes#

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130010939956293GTIN-13: 0010939956293
EAN-13: 0010939956293
GTIN-12: 010939956293
UPC-A: 010939956293
GTIN storage (14 digits): 00010939956293		gas-relief-125-mg-green-softgel-pat-1.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70677-1092-1Gas Relief1 in 1 BLISTER PACKCAPSULE, LIQUID FILLED14
70677-1092-1Gas Relief30 in 1 CARTONCAPSULE, LIQUID FILLED304

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70677-1092-1EA - Each70677-10927f6edda9-d416-44cc-b7c5-846459807f9f12023-09-05

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70677-109270677-1092-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIMETHICONE92RU3N3Y1OACTIB
D&C YELLOW NO. 1035SW5USQ3GIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C RED NO. 40WZB9127XOAIACT
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
PEPPERMINT OILAV092KU4JHIACT
WATER059QF0KO0RIACT
SORBITAN6O92ICV9RUIACT
SORBITOL506T60A25RIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
MANNITOL3OWL53L36AIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22024-05-31full-release2026-06-01 00:13:16

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 ReliefSIMETHICONEStrategic Sourcing Services LLCfa85df3f-243d-470b-ad28-82512e05fbbe2025-11-19WarningsExact identifier
ndc (package): 70677-1092-1
ndc (product): 70677-1092
ndc11 (package): 70677109201
spl id: f1a34aaa-10d3-4282-b8e0-b28167b4a680
spl set id: fa85df3f-243d-470b-ad28-82512e05fbbe

Reported adverse events (FAERS/openFDA)#

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