Ultra Strength Gas Relief

Manufacturer: PuraCap Pharmaceutical LLC | Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.
Effective date: 2017-07-17
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:51:57

Label at a glance#

ProductUltra Strength Gas Relief

Active ingredientDIMETHICONE

Label structure10 sections

Indications and uses

relieves bloating, pressure or fullness commonly referred to as gas

Dosage and administration

swallow 1 or 2 softgels as needed after a meal do not exceed two softgels per day except under the advice and supervision of a physician

Storage and handling

store at room temperature 59º - 86ºF (15º - 30ºC)

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

Anti-gas

Uses

INDICATIONS & USAGE SECTION

relieves bloating, pressure or fullness commonly referred to as gas

Warnings

WARNINGS SECTION

OTC - STOP USE SECTION

Stop use and ask a doctor if condition persists

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Directions

DOSAGE & ADMINISTRATION SECTION

swallow 1 or 2 softgels as needed after a meal
do not exceed two softgels per day except under the advice and supervision of a physician

Other information

STORAGE AND HANDLING SECTION

store at room temperature 59º - 86ºF (15º - 30ºC)

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free: 1-855-215-8180

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Ultra Strength Gas Relief

Simethicone 180 mg Anti-gas 60 Softgels

NDC 51013-123-22

*Compare to the active ingredient in PHAZYME^® Ultra Strength

DDM08-03 front

DDM08-03 back

DDM09-03

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
51013-123-22	2025-01-30	C162847	48780-1	2cef2736-671b-d83d-e063-dadaa90ab31f	Ultra Strength Gas Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
51013-123-22	Ultra Strength Gas Relief	60 in 1 BOTTLE	CAPSULE, LIQUID FILLED	60		1
51013-123-22	Ultra Strength Gas Relief	1 in 1 CARTON	CAPSULE, LIQUID FILLED	1		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51013-123	ULTRA STRENGTH GAS RELIEF (SIMETHICONE) CAPSULE, LIQUID FILLED [PURACAP PHARMACEUTICAL LLC]	1	Legacy NDC, 2 package rows	20170717_20d0675a-9540-4d5d-9cd3-fa620269a53d.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
51013-123	51013-123-22

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
0feaf992-2a4c-44f1-81a1-62558ef12c83			20d0675a-9540-4d5d-9cd3-fa620269a53d	2017-07-17	Warnings	Exact identifier spl id: 0feaf992-2a4c-44f1-81a1-62558ef12c83 spl set id: 20d0675a-9540-4d5d-9cd3-fa620269a53d

Reported adverse events (FAERS/openFDA)#

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