SIMETHICONE CAPSULES 250 mg, liquid filled

Manufacturer: PURACAP PHARMACEUTICAL LLC | Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.
Effective date: 2019-12-20
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-05-31 23:02:14

Label at a glance#

ProductMaximum Strength Gas Relief

Active ingredientDIMETHICONE

Label structure10 sections

Dosage and administration

swallow one or two softgels after a meal do not exceed two softgels per 24 hours except under the advice and supervision of a physician

Storage and handling

store at room temperature 59°-86°F (15°-30°C)

Contacts and useful links#

PhoneLabel contact1-855-215-8180

Label contents#

Full prescribing information#

Active ingredient (in each softgel)

OTC - ACTIVE INGREDIENT SECTION

Simethicone 250 mg

Purpose

OTC - PURPOSE SECTION

Anti-gas

Use

INDICATIONS & USAGE SECTION

relieves bloating, pressure or fullness commonly referred to as gas

Warnings

WARNINGS SECTION

Stop use and ask a doctor if

OTC - STOP USE SECTION

condition persists

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Directions

DOSAGE & ADMINISTRATION SECTION

swallow one or two softgels after a meal
do not exceed two softgels per 24 hours except under the advice and supervision of a physician

Other information

STORAGE AND HANDLING SECTION

store at room temperature 59°-86°F (15°-30°C)

Inactive ingredients

INACTIVE INGREDIENT SECTION

D&C red #33, FD&C blue #1, gelatin, glycerin, purified water, and white edible ink

Questions or Comments?

OTC - QUESTIONS SECTION

Call: 1-855-215-8180

PRINCIPAL DISPLAY PANEL - 24ct

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CVS MAXIMUM STRENGTH GAS RELIEF Anti-gas

SIMETHICONE 250 mg

NDC 51013-127-04

Compare to the active ingredient in PHAZYME^® Maximum Strength

24 Liquid-Filled SoftGels

Carton 24ct

PRINCIPAL DISPLAY PANEL - 60ct

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CVS MAXIMUM STRENGTH GAS RELIEF Anti-gas

SIMETHICONE 250 mg

NDC 51013-127-22

Compare to the active ingredient in PHAZYME^® Maximum Strength

60 Liquid-Filled SoftGels

Carton 60ct

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
412111	simethicone 250 MG Oral Capsule	PSN	2
412111	simethicone 250 MG Oral Capsule	SCD	2
412111	dimethicone 250 MG Oral Capsule	SY	2

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
51013-127-04	2025-01-30	C162847	48780-1	2cef2736-9c2a-d83d-e063-dadaa90ab31f	SIMETHICONE CAPSULES 250 mg, liquid filled
51013-127-22	2025-01-30	C162847	48780-1	2cef2736-9c2a-d83d-e063-dadaa90ab31f	SIMETHICONE CAPSULES 250 mg, liquid filled

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
51013-127-04	Maximum Strength Gas Relief	2 in 1 CARTON	CAPSULE, LIQUID FILLED	2	2
51013-127-04	Maximum Strength Gas Relief	12 in 1 BLISTER PACK	CAPSULE, LIQUID FILLED	12	2
51013-127-22	Maximum Strength Gas Relief	60 in 1 BOTTLE, PLASTIC	CAPSULE, LIQUID FILLED	60	2
51013-127-22	Maximum Strength Gas Relief	1 in 1 CARTON	CAPSULE, LIQUID FILLED	1	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51013-127	MAXIMUM STRENGTH GAS RELIEF (SIMETHICONE) CAPSULE, LIQUID FILLED [PURACAP PHARMACEUTICAL LLC]	2	Legacy NDC, 4 package rows	20191221_e36e2db8-c822-4681-a004-c496e8970543.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51013-127-04	EA - Each	51013-127	6281f552-4558-4876-9102-02d00c07cfa0	1	2022-06-06
51013-127-22	EA - Each	51013-127	167f7a65-bd80-462a-b1a4-a5ad99736c5f	1	2022-06-06

Products#

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

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

Maximum Strength Gas Relief
Simethicone
DIMETHICONE
D&C RED NO. 33
FD&C BLUE NO. 1
GELATIN
GLYCERIN
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
51013-127	51013-127-04, 51013-127-22

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
DIMETHICONE	92RU3N3Y1O	ACTIB
D&C RED NO. 33	9DBA0SBB0L	IACT
FD&C BLUE NO. 1	H3R47K3TBD	IACT
GELATIN	2G86QN327L	IACT
GLYCERIN	PDC6A3C0OX	IACT
WATER	059QF0KO0R	IACT

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
934906a6-004b-406c-b560-35672343a86a			e36e2db8-c822-4681-a004-c496e8970543	2019-12-20	Warnings	Exact identifier spl id: 934906a6-004b-406c-b560-35672343a86a spl set id: e36e2db8-c822-4681-a004-c496e8970543

Reported adverse events (FAERS/openFDA)#

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