FDA.reportPublic FDA data

Gas Relief

Manufacturer
P & L Development, LLC
Effective date
2023-04-18
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:32:49

Label at a glance#

ProductGas Relief Extra Strength
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 : 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 physican

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: 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 physican

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

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

†Compare to the active ingredient in Gas-X® Extra Strength

extra strength

gas relief

simethicone 125 mg

anti-gas

fast relief of

  • Pressure
  • bloating
  • discomfort

softgels

†This product is not manufactured or distributed by GSK Consumer Healthcare, distributor of Gas-X® Extra 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:

PL Developments

200 Hicks Street, Westbury, NY 11590

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

WELLNESS BASICS Extra Strength Gas Relief
WELLNESS BASICS Extra Strength Gas Relief

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59726-097-302023-04-18C16284748780-1d6a99b39-8519-a426-e053-dadaa90af4c2Drug Facts
59726-097-302022-01-28C16284748780-1d6a99b39-8519-a426-e053-dadaa90af4c2Drug Facts

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59726-097GAS RELIEF EXTRA STRENGTH (SIMETHICONE) CAPSULE, LIQUID FILLED [P & L DEVELOPMENT, LLC]2Legacy NDC20230420_b58bf9be-755f-4c5b-a6f4-b60f5bf5ac3b.zip

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
59726-09759726-097-30

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

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
52f641a2-6b2b-429c-b119-cafe9dd203d3b58bf9be-755f-4c5b-a6f4-b60f5bf5ac3b2023-04-18WarningsExact identifier
spl id: 52f641a2-6b2b-429c-b119-cafe9dd203d3
spl set id: b58bf9be-755f-4c5b-a6f4-b60f5bf5ac3b

Reported adverse events (FAERS/openFDA)#

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