gas relief - BIONPHARMA INC. | Ocean Healthcare Pvt Ltd

Manufacturer: BIONPHARMA INC. | Ocean Healthcare Pvt Ltd
Effective date: 2026-03-20
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-06-01 01:52:15

Label at a glance#

Productgas relief

Active ingredientDIMETHICONE

Label structure13 sections

Indications and uses

relieves bloating, pressure, fullness, commonly referred to as gas.

Dosage and administration

■ adults and children 12 years and older: swallow with water 1 capsule or 2 capsules as needed after meals and at bedtime. ■ do not exceed 4 capsules in 24 hours except under the advice and supervision of a physician.

Storage and handling

■ store at 20°-25°C (68°-77°F) ■ protect from light, heat and moisture.

Contacts and useful links#

PhoneLabel contact1-888-235-2466

Label contents#

Full prescribing information#

Active ingredient (in each capsules)

OTC - ACTIVE INGREDIENT SECTION

Simethicone USP, 125 mg

Purpose

OTC - PURPOSE SECTION

Antigas

Uses

INDICATIONS & USAGE SECTION

relieves bloating, pressure, fullness, commonly referred to as gas.

WARNINGS SECTION

Warnings

Stop use and ask a doctor if

OTC - ASK DOCTOR SECTION

condition persists.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all drugs out of the reach of children.

Directions

DOSAGE & ADMINISTRATION SECTION

■ adults and children 12 years and older: swallow with water 1 capsule or 2 capsules as needed after meals and at bedtime.
■ do not exceed 4 capsules in 24 hours except under the advice and supervision of a physician.

Other information

STORAGE AND HANDLING SECTION

■ store at 20°-25°C (68°-77°F)
■ protect from light, heat and moisture.

Inactive ingredients

INACTIVE INGREDIENT SECTION

D&C yellow no. 10, FD&C blue no. 1, FD&C red no. 40, gelatin, glycerin, peppermint oil, pharmaceutical imprinting ink, purified water, sorbitol, and titanium dioxide

Questions?

OTC - QUESTIONS SECTION

call 1-888-235-2466

SPL UNCLASSIFIED SECTION

***This product is not manufactured or distributed by the owner of the registered trademark Gas-X® Extra Strength.

Manufactured for:
BIONPHARMA
Princeton, NJ 08540
MADE IN INDIA

Code:TN/Drugs/TN00003701

L0001239 R0226

125 mg label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

***compare to the active ingredient in
Gas-X® Extra Strength

a+ health

extra strength

gas relief

simethicone capsules USP, 125 mg

antigas

relieves: ● bloating ● pressure
● fullness ● discomfort

250 SOFTGELS**

**liquid-filled capsules

label

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69452-542-28	gas relief	250 in 1 BOTTLE	CAPSULE, LIQUID FILLED	250		1

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

gas relief
simethicone
SORBITOL
GLYCERIN
FD&C RED NO. 40
GELATIN, UNSPECIFIED
TITANIUM DIOXIDE
FD&C BLUE NO. 1
DIMETHICONE
D&C YELLOW NO. 10
WATER
PEPPERMINT OIL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
69452-542	69452-542-28

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
SORBITOL	506T60A25R	IACT
GLYCERIN	PDC6A3C0OX	IACT
FD&C RED NO. 40	WZB9127XOA	IACT
GELATIN, UNSPECIFIED	2G86QN327L	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
FD&C BLUE NO. 1	H3R47K3TBD	IACT
DIMETHICONE	92RU3N3Y1O	ACTIB
D&C YELLOW NO. 10	35SW5USQ3G	IACT
WATER	059QF0KO0R	IACT
PEPPERMINT OIL	AV092KU4JH	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
gas relief	SIMETHICONE	BIONPHARMA INC.	4d7a9507-6f3c-6d15-e063-6294a90a0160	2026-03-20	Warnings	Exact identifier ndc (package): 69452-542-28 ndc (product): 69452-542 ndc11 (package): 69452054228 spl id: 4d7a9507-6f3d-6d15-e063-6294a90a0160 spl set id: 4d7a9507-6f3c-6d15-e063-6294a90a0160

Reported adverse events (FAERS/openFDA)#

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