Ultra Strength Gas Relief

Manufacturer: PuraCap Pharmaceutical LLC | Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.
Effective date: 2018-02-08
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:54:24

Label at a glance#

ProductUltra Strength Gas Relief

Active ingredientDIMETHICONE

Label structure10 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 controlled room temperature 15º - 30ºC (59º - 86ºF) protect from heat and moisture

Contacts and useful links#

PhoneLabel contact1-855-215-8180

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

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 controlled room temperature 15º - 30ºC (59º - 86ºF)
protect from heat and moisture

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD&C yellow#6, gelatin, glycerin, purified water and white ink

Questions or comments?

OTC - QUESTIONS SECTION

Call: 1-855-215-8180

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Ultra Strength Gas Relief

Simethicone 180 mg Antigas 50 Softgels

NDC 51013-428-09

*Compare to the active ingredient in Gas-X^® Ultra Strength

Ultra Strength Gas Relief 50ct

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
252294	simethicone 180 MG Oral Capsule	PSN	1
252294	simethicone 180 MG Oral Capsule	SCD	1
252294	dimethicone 180 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
51013-428-09	2025-01-30	C162847	48780-1	2cef2736-94cd-d83d-e063-dadaa90ab31f	Ultra Strength Gas Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
51013-428-09	Ultra Strength Gas Relief	10 in 1 BLISTER PACK	CAPSULE, LIQUID FILLED	10		1
51013-428-09	Ultra Strength Gas Relief	5 in 1 CARTON	CAPSULE, LIQUID FILLED	5		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51013-428	ULTRA STRENGTH GAS RELIEF (SIMETHICONE) CAPSULE, LIQUID FILLED [PURACAP PHARMACEUTICAL LLC]	1	Legacy NDC, 2 package rows	20180208_247fcde0-aec5-4e1d-b202-95785aa7f72a.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

Ultra Strength Gas Relief
Simethicone
DIMETHICONE
FD&C YELLOW NO. 6
GELATIN
GLYCERIN
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
51013-428	51013-428-09

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
DIMETHICONE	92RU3N3Y1O	ACTIB
FD&C YELLOW NO. 6	H77VEI93A8	IACT
GELATIN	2G86QN327L	IACT
GLYCERIN	PDC6A3C0OX	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
1f1348b4-3823-4c78-bb8b-8eb0df1b9b9f			247fcde0-aec5-4e1d-b202-95785aa7f72a	2018-02-08	Warnings	Exact identifier spl id: 1f1348b4-3823-4c78-bb8b-8eb0df1b9b9f spl set id: 247fcde0-aec5-4e1d-b202-95785aa7f72a

Reported adverse events (FAERS/openFDA)#

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