FDA.reportPublic FDA data

Gas Relief

Manufacturer
Safeway, Inc.
Effective date
2024-05-14
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:12:28

Label at a glance#

ProductGas Relief Ultra Strength
Active ingredientDIMETHICONE
Label structure10 sections

Indications and uses

relieves bloating, pressure, or fullness commonly referred to as gas

Dosage and administration

swallow one or two softgels as symptoms occur do not exceed two softgels per  24  hours except under the advice and supervision of a physician

Storage and handling

store between 15-30°C (59-86°F) protect from heat and moisture

Label contents#

Full prescribing information#

Active ingredient (in each softgel)

OTC - ACTIVE INGREDIENT SECTION

Simethicone 180 mg

Purpose

OTC - PURPOSE SECTION

Antigas

Uses

INDICATIONS & USAGE SECTION

  • relieves bloating, pressure, or fullness commonly referred to as gas

Warnings

WARNINGS SECTION

Stop use and ask a doctor if

OTC - STOP USE SECTION

condition persists

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

  • swallow one or two softgels as symptoms occur
  • do not exceed two softgels per  24  hours except under the advice and supervision of a physician

Other information

STORAGE AND HANDLING SECTION

  • store between 15-30°C (59-86°F)
  • protect from heat and moisture

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD&C red #40, FD&C yellow #6, gelatin, glycerin

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

COMPARE TO Phazyme® Ultra Strength active ingredient†

Ultra Strength

Gas Relief

SIMETHICONE 180 mg

antiflatulent (Antigas

Fast Relief of:

  • Gas
  • Pressure  
  • Bloating 
  • Discomfort

SOFTGELS

†This product is not manufactured or distributed by C.B. Fleet Company, Inc., distributor of Phazyme® Ultra Strength.

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.

DISTRIBUTED BY

BETTER LIBING BRANDS LLC

P.O. BOX 99, PLEASANTON, CA 94566-0009

www.betterlivingbrandsllc.com

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SIGNATURE CARE Ultra Strength Gas Relief
SIGNATURE CARE Ultra Strength Gas Relief

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
252294simethicone 180 MG Oral CapsulePSN3
252294simethicone 180 MG Oral CapsuleSCD3
252294dimethicone 180 MG Oral CapsuleSY3

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
21130-073-60Gas ReliefUltra Strength1 in 1 BLISTER PACKCAPSULE, LIQUID FILLED13
21130-073-60Gas ReliefUltra Strength60 in 1 CARTONCAPSULE, LIQUID FILLED603

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21130-073GAS RELIEF ULTRA STRENGTH (SIMETHICONE) CAPSULE, LIQUID FILLED [SAFEWAY, INC.]3Current NDC, Legacy NDC, 2 package rows20240515_8927d9eb-65b2-40f3-846c-dc9cd2884dea.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
21130-07321130-073-60

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIMETHICONE92RU3N3Y1OACTIB
FD&C RED NO. 40WZB9127XOAIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT

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 Relief Ultra StrengthSIMETHICONESafeway, Inc.8927d9eb-65b2-40f3-846c-dc9cd2884dea2024-05-14WarningsExact identifier
ndc (package): 21130-073-60
ndc (product): 21130-073
ndc11 (package): 21130007360
spl id: c70dc793-1be2-40b1-986a-2340e452ee1c
spl set id: 8927d9eb-65b2-40f3-846c-dc9cd2884dea

Reported adverse events (FAERS/openFDA)#

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