Gas Relief

Manufacturer: PuraCap Pharmaceutical LLC | Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.
Effective date: 2017-11-22
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:53:03

Label at a glance#

ProductGas Relief

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 except under the advice and supervision of a physician

Storage and handling

store at room temperature 15°-30°C (59°-86°F) protect from light, heat and moisture

Contacts and useful links#

PhoneLabel contact1-800-719-9260

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

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

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 4 softgels in 24 hours except under the advice and supervision of a physician

Other information

STORAGE AND HANDLING SECTION

store at room temperature 15°-30°C (59°-86°F)
protect from light, heat and moisture

Inactive ingredients

INACTIVE INGREDIENT SECTION

D&C yellow #10, FD&C blue #1, FD&C red #40, gelatin, glycerin, peppermint oil, purified water, white edible ink

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free: 1-800-719-9260

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

EXTRA STRENGTH GAS RELIEF

SIMETHICONE 125 mg ANTIGAS 20 Softgels

NDC 51013-423-08

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

HT04-00-front

HT04-00-back

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
198852	simethicone 125 MG Oral Capsule	PSN	1
198852	simethicone 125 MG Oral Capsule	SCD	1
198852	dimethicone 125 MG Oral Capsule	SY	1

DailyMed Pharmacologic Classes#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
51013-423-08	2025-01-30	C162847	48780-1	2cef2736-7bf3-d83d-e063-dadaa90ab31f	Gas Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
51013-423-08	Gas Relief	10 in 1 BLISTER PACK	CAPSULE, LIQUID FILLED	10		1
51013-423-08	Gas Relief	2 in 1 CARTON	CAPSULE, LIQUID FILLED	2		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51013-423	GAS RELIEF (SIMETHICONE) CAPSULE, LIQUID FILLED [PURACAP PHARMACEUTICAL LLC]	1	Legacy NDC, 2 package rows	20171122_5eea7dfd-09c5-48db-8057-4f8c81200f4a.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

Gas Relief
Simethicone
DIMETHICONE
D&C YELLOW NO. 10
FD&C BLUE NO. 1
FD&C RED NO. 40
GELATIN
GLYCERIN
PEPPERMINT OIL
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
51013-423	51013-423-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
DIMETHICONE	92RU3N3Y1O	ACTIB
D&C YELLOW NO. 10	35SW5USQ3G	IACT
FD&C BLUE NO. 1	H3R47K3TBD	IACT
FD&C RED NO. 40	WZB9127XOA	IACT
GELATIN	2G86QN327L	IACT
GLYCERIN	PDC6A3C0OX	IACT
PEPPERMINT OIL	AV092KU4JH	IACT
WATER	059QF0KO0R	IACT

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
6732619f-c0e5-44be-98eb-224eea9d9ecf			5eea7dfd-09c5-48db-8057-4f8c81200f4a	2017-11-22	Warnings	Exact identifier spl id: 6732619f-c0e5-44be-98eb-224eea9d9ecf spl set id: 5eea7dfd-09c5-48db-8057-4f8c81200f4a

Reported adverse events (FAERS/openFDA)#

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