ULTIMATE STRENGTH GAS RELIEF- simethicone capsule, liquid filled

Manufacturer: Advanced Rx LLC | Ocean Healthcare Pvt Ltd
Effective date: 2026-02-01
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-06-01 01:46:23

Label at a glance#

ProductGas Relief Ultimate Strength Softgels

Active ingredientDIMETHICONE, UNSPECIFIED

Label structure9 sections

Dosage and administration

adults and children 12 years and older: swallow with water 1 softgel as needed after meals or at bedtime do not exceed 1 softgel in 24 hours except under the advice and supervision of a physician

Storage and handling

store at 20º to 25ºC (68º to 77ºF) protect from light, heat and moisture

Contacts and useful links#

PhoneLabel contact1-800-630-8895

Label contents#

Full prescribing information#

Active ingredient (in each softgel)

OTC - ACTIVE INGREDIENT SECTION

Simethicone 500 mg

Purpose

OTC - PURPOSE SECTION

Antigas

Use

INDICATIONS & USAGE SECTION

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

Warning

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 chindren.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children 12 years and older:swallow with water 1 softgel as needed after meals or at bedtime
do not exceed 1 softgel in 24 hours except under the advice and supervision of a physician

Other information

STORAGE AND HANDLING SECTION

store at 20º to 25ºC (68º to 77ºF)
protect from light, heat and moisture

Inactive ingredients

INACTIVE INGREDIENT SECTION

Gelatin, glycerin, purified water, sorbitol.

Questions?

OTC - QUESTIONS SECTION

call 1-800-630-8895

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
2477951	simethicone 500 MG Oral Capsule	PSN	1
2477951	simethicone 500 MG Oral Capsule	SCD	1

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
DIMETHICONE Pharmacologic Class Indexing	3	Indexing - Pharmacologic Class	20180813

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Barcode	EAN-13	0380513001917	GTIN-13: 0380513001917 EAN-13: 0380513001917 GTIN-12: 380513001917 UPC-A: 380513001917 GTIN storage (14 digits): 00380513001917	label.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
80513-119-01	Gas ReliefUltimate Strength Softgels	100 in 1 BOTTLE	CAPSULE, LIQUID FILLED	100		1
80513-119-50	Gas ReliefUltimate Strength Softgels	50 in 1 BOTTLE	CAPSULE, LIQUID FILLED	50		1

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

Gas Relief Ultimate Strength Softgels
Simethicone
GELATIN, UNSPECIFIED
GLYCERIN
WATER
SORBITOL
DIMETHICONE, UNSPECIFIED
DIMETHICONE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
80513-119	80513-119-50, 80513-119-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
GELATIN, UNSPECIFIED	2G86QN327L	IACT
GLYCERIN	PDC6A3C0OX	IACT
WATER	059QF0KO0R	IACT
SORBITOL	506T60A25R	IACT
DIMETHICONE, UNSPECIFIED	92RU3N3Y1O	ACTIB

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Gas Relief Ultimate Strength Softgels	SIMETHICONE	Advanced Rx LLC	5d412711-efd3-4b27-bfde-6fee2f460f8b	2026-02-01	Warnings	Exact identifier ndc (package): 80513-119-50 ndc (package): 80513-119-01 ndc (product): 80513-119 ndc11 (package): 80513011901 ndc11 (package): 80513011950 spl id: 4b13d80d-b9c0-6dee-e063-6294a90aab41 spl set id: 5d412711-efd3-4b27-bfde-6fee2f460f8b

Reported adverse events (FAERS/openFDA)#

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