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 22:30:21

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 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

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 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*

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 Phazyme® Ultra Strength†

ultra strength

gas Relief

simethicone 180 mg

antiflatulent (antigas)

Fast Relief of:

  • pressure  
  • bloating 
  • discomfort

softgels

small, easy to swallow

†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:

PL Developments

200 Hicks Street

Westbury, NY  11590

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

READYinCASE Ultra Strength Gas Relief
READYinCASE Ultra Strength Gas Relief

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59726-732-102020-12-05C16284748780-1ab0e2407-28c0-f274-e053-dbdaa90a6471Drug Facts
59726-732-102020-09-27C16284748780-1ab0e2407-28c0-f274-e053-dbdaa90a6471Drug Facts
59726-732-102020-09-25C16284748780-1ab0e2407-28c0-f274-e053-dbdaa90a6471Drug Facts
59726-732-102020-07-22C16284748780-1ab0e2407-28c0-f274-e053-dbdaa90a6471Drug Facts

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
59726-73259726-732-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 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
afbf933d-389f-4b09-a3d4-509c8a0176c5474b8a31-021b-41af-8738-0cc28b58949c2021-10-26WarningsExact identifier
spl id: afbf933d-389f-4b09-a3d4-509c8a0176c5
spl set id: 474b8a31-021b-41af-8738-0cc28b58949c

Reported adverse events (FAERS/openFDA)#

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