Gas Relief

Manufacturer
Advanced Rx LLC
Effective date
2024-08-30
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:18:18

Label at a glance#

ProductGas Relief
Active ingredientDIMETHICONE
Label structure11 sections

Dosage and administration

adults and children 12 years and older: 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 at 20° to 25°C (68° to 77°F) protect from light, heat and moisture DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED

Label contents#

Full prescribing information#

Active ingredient (in each softgel)

OTC - ACTIVE INGREDIENT SECTION

Simethicone 250 mg

Purpose

OTC - PURPOSE SECTION

Antigas

Use

INDICATIONS & USAGE SECTION

for the relief of pressure, bloating, and fullness, commonly referred to as gas.

OTC - ASK DOCTOR SECTION

Stop use and ask a doctor if condition persists

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If pregnant or breast-feeding,ask a health professional before use.

Keep out of reach of children.

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 12 years and older: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 at 20° to 25°C (68° to 77°F)
  • protect from light, heat and moisture
  • DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED

Inactive ingredients

INACTIVE INGREDIENT SECTION

D&C red #33, FD&C blue #1, gelatin, glycerin, purified water and white edible ink.

Questions?

OTC - QUESTIONS SECTION

call 1-800-630-8895

SPL UNCLASSIFIED SECTION

Distributed by:

Advanced Rx LLC

1942 NE 163rd St North Miami Beach,

FL 33162 U.S.A.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 80513-112-01

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

HIGH POTENCY

GAS RELIEF

Simethicone 250 mg

• RELIEVES GAS FAST

• PRESSURE

• BLOATING

• DISCOMFORT

100 SOFTGELS

†This product is not manufactured or distributed by the owner of the registered trademark Maximum Strength Gas-X ®

CartonCarton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
412111simethicone 250 MG Oral CapsulePSN1
412111simethicone 250 MG Oral CapsuleSCD1
412111dimethicone 250 MG Oral CapsuleSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIMETHICONE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80513-112-01Gas Relief100 in 1 BOTTLECAPSULE, LIQUID FILLED1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80513-112GAS RELIEF (SIMETHICONE) CAPSULE, LIQUID FILLED [ADVANCED RX LLC]1Current NDC, 1 package rows20240831_57d31610-c658-49cf-9de3-01e8143aeace.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
80513-11280513-112-01

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
Gas ReliefSIMETHICONEAdvanced Rx LLC57d31610-c658-49cf-9de3-01e8143aeace2024-08-30WarningsExact identifier
ndc (package): 80513-112-01
ndc (product): 80513-112
ndc11 (package): 80513011201
spl id: 20e14e77-6853-f7d1-e063-6294a90a4487
spl set id: 57d31610-c658-49cf-9de3-01e8143aeace

Reported adverse events (FAERS/openFDA)#

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