FDA.reportPublic FDA data

Ultra Strength Gas Relief

Manufacturer
Meijer Distribution Inc.
Effective date
2024-12-20
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 00:47:22

Label at a glance#

ProductUltra Strength Gas Relief
Active ingredientDIMETHICONE
Label structure12 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 at a controlled room temperature 20-25°C (68-77°F) ■ protect from heat and moisture

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

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

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

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 at a controlled room temperature 20-25°C (68-77°F)
■ protect from heat and moisture

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD&C yellow #6, gelatin, glycerin, peppermint oil, povidone, purified
water, sorbitol solution, titanium dioxide

OTC - QUESTIONS SECTION

Questions or comments? 1-888-333-9792

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY:

MEIJER DISTRIBUTION, INC.

GRAND RAPIDS, MI 49544

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to the active

ingredient in Gas-X®

Ultra Strength Softgels*

Simethicone 180mg

Anti-gas

Fast Relief of:

Bloating

Pressure

Fullness

Gas

Easy to swallow softgels

50 Softgels

CartonCarton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
252294simethicone 180 MG Oral CapsulePSN8
252294simethicone 180 MG Oral CapsuleSCD8
252294dimethicone 180 MG Oral CapsuleSY8

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41250-736-50Ultra Strength Gas Relief5 in 1 CARTONCAPSULE, LIQUID FILLED58
41250-736-50Ultra Strength Gas Relief10 in 1 BLISTER PACKCAPSULE, LIQUID FILLED108

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41250-736ULTRA STRENGTH GAS RELIEF (SIMETHICONE) CAPSULE, LIQUID FILLED [MEIJER DISTRIBUTION INC.]8Legacy NDC, 2 package rows20241222_301fed9d-d5c6-4ecb-a6c6-0730f2ef0fd2.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
41250-73641250-736-50

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
FD&C YELLOW NO. 6H77VEI93A8IACT
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
PEPPERMINT OILAV092KU4JHIACT
POVIDONE K30U725QWY32XIACT
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
DIMETHICONE92RU3N3Y1OACTIB

Source Document#

Source XML · Source PDF

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
29ba9c62-8ea4-3ae2-e063-6294a90a4b76301fed9d-d5c6-4ecb-a6c6-0730f2ef0fd22024-12-20WarningsExact identifier
spl id: 29ba9c62-8ea4-3ae2-e063-6294a90a4b76
spl set id: 301fed9d-d5c6-4ecb-a6c6-0730f2ef0fd2

Reported adverse events (FAERS/openFDA)#

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