FDA.reportPublic FDA data

Gas Relief

Manufacturer
Rite Aid Corporation
Effective date
2023-02-20
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:36:16

Label at a glance#

ProductGas Relief Ultra Strength
Active ingredientDIMETHICONE
Label structure10 sections

Indications and uses

For the relief of pressure and bloating commonly referred to as gas

Dosage and administration

adults: swallow with water 1 or 2 softgels as needed after meals and at bedtime do not exceed 2 softgels in 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

For the relief of pressure and bloating 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: swallow with water 1 or 2 softgels as needed after meals and at bedtime
  • do not exceed 2 softgels in 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, purified water, white printing ink*

*contains one or more of these ingredients

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 the active ingredient in Gas-X® Ultra Strength†

ULTRA STRENGTH

GAS RELIEF

SIMETHICONE 180 mg

ANTIGAS

Fast Relief of:

  • gas
  • pressure  
  • bloating 
  • discomfort

small, easy to swallow

SOFTGELS

†This product is not manufactured or distributed by GSK Consumer Healthcare, distributor of Gas-X® Ultra Strength.

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

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

DISTRIBUTED BY:

RITE AID, 30 HENTER LANE,

CAMP HILL, PA 17011

www.riteaid.com

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

RITE AID PHARMACY Ultra Strength Gas Relief
RITE AID PHARMACY Ultra Strength Gas Relief

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
11822-8330-52023-02-20C16284748780-1ab0e2407-2836-f274-e053-dbdaa90a6471Drug Facts
11822-8330-52022-01-28C16284748780-1ab0e2407-2836-f274-e053-dbdaa90a6471Drug Facts
11822-8330-52020-11-17C16284748780-1ab0e2407-2836-f274-e053-dbdaa90a6471Drug Facts
11822-8330-52020-09-27C16284748780-1ab0e2407-2836-f274-e053-dbdaa90a6471Drug Facts
11822-8330-52020-09-25C16284748780-1ab0e2407-2836-f274-e053-dbdaa90a6471Drug Facts
11822-8330-52020-07-22C16284748780-1ab0e2407-2836-f274-e053-dbdaa90a6471Drug Facts

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-8330GAS RELIEF ULTRA STRENGTH (SIMETHICONE) CAPSULE, LIQUID FILLED [RITE AID CORPORATION]3Legacy NDC20230221_e86d0fee-a1e6-4bf4-b01a-16439c93c9d0.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11822-833011822-8330-5

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIMETHICONE92RU3N3Y1OACTIB
FD&C RED NO. 40WZB9127XOAIACT
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
a7eed1c8-90d1-4b66-b1bf-347ccab62202e86d0fee-a1e6-4bf4-b01a-16439c93c9d02023-02-20WarningsExact identifier
spl id: a7eed1c8-90d1-4b66-b1bf-347ccab62202
spl set id: e86d0fee-a1e6-4bf4-b01a-16439c93c9d0

Reported adverse events (FAERS/openFDA)#

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