FDA.reportPublic FDA data

Gas Relief

Manufacturer
Safeway, Inc.
Effective date
2021-11-05
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 22:29:02

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 needed after a meal do not exceed two softgels per day except under the advice and supervision of a physican

Storage and handling

store at 15º-30ºC (59º-86ºF)

Label contents#

Full prescribing information#

Active ingredient (in each softgel)

OTC - ACTIVE INGREDIENT SECTION

Simethicone 180 mg

Purpose

OTC - PURPOSE SECTION

Antiflatulent (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 needed after a meal
  • do not exceed two softgels per day except under the advice and supervision of a physican

Other information

STORAGE AND HANDLING SECTION

  • store at 15º-30ºC (59º-86ºF)

Inactive ingredients

INACTIVE INGREDIENT SECTION

edible ink, FD&C yellow #6, gelatin, glycerin, purified water

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-888-723-3929 Monday-Friday 7AM-6PM PST

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

COMPARE TO Phazyme® Ultra Strength active ingredient**

Ultra Strength

Gas Relief

SIMETHICONE 180 mg

Antigas

Fast relief of:

  • Pressure
  • Bloating
  • Discomfort

Small, Easy to Swallow

SOFTGEL

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

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

KEEP OUTER CARTON FOR COMPLETS WARNINGS AND PRODUCT INFORMATION

DISTRIBUTED BY

BETTER LIVING 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

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
21130-53021130-530-60

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 YELLOW NO. 6H77VEI93A8IACT
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT

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
6cfe25a5-fe7d-46a4-a775-5a7a53ef1e94121888fa-0949-4faf-b63e-0e47e964ae5f2021-11-05WarningsExact identifier
spl id: 6cfe25a5-fe7d-46a4-a775-5a7a53ef1e94
spl set id: 121888fa-0949-4faf-b63e-0e47e964ae5f

Reported adverse events (FAERS/openFDA)#

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