Gas Relief

Manufacturer
P & L Development, LLC
Effective date
2021-10-26
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 22:30:40

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 unless directed by a doctor

Storage and handling

store between 15-30°C (59-86°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 unless directed by a doctor

Other information

STORAGE AND HANDLING SECTION

  • store between 15-30°C (59-86°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, peppermint oil, purified water, sorbitan, sorbitol, titanium dioxide

*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

extra strength

gas relief

simethicone 125 mg

anti-gas

fast relief of

  • Pressure
  • bloating
  • discomfort

softgels

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

†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

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59726-08759726-087-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

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
2b5aaa17-0050-4bf0-8459-5e36603301cae1ed32e3-5b75-4f9e-bd8c-e5154467e93f2021-10-26WarningsExact identifier
spl id: 2b5aaa17-0050-4bf0-8459-5e36603301ca
spl set id: e1ed32e3-5b75-4f9e-bd8c-e5154467e93f

Reported adverse events (FAERS/openFDA)#

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