EXTRA STRENGTH SIMETHICONE

Manufacturer: Bi-Mart | LNK International, Inc.
Effective date: 2025-09-01
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-06-01 01:14:29

Label at a glance#

ProductEXTRA STRENGTH SIMETHICONE

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: chew one or two tablets as needed after meals and at bedtime do not exceed 4 tablets in 24 hours except under the advice and supervision of a physician

Storage and handling

each tablet contains: calcium 85 mg TAMPER EVIDENT: DO NOT USE IF SEAL AROUN TABLET IS BROKEN OR DAMAGED store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) protect from moisture

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-844-912-4012

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

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

If pregnant or breast feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental overdose, get medical help or a Poison Control Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

adults:chew one or two tablets as needed after meals and at bedtime
do not exceed 4 tablets in 24 hours except under the advice and supervision of a physician

Other information

STORAGE AND HANDLING SECTION

each tablet contains:calcium 85 mg
TAMPER EVIDENT:DO NOT USE IF SEAL AROUN TABLET IS BROKEN OR DAMAGED
store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
protect from moisture

Inactive ingredients

INACTIVE INGREDIENT SECTION

crospovidone, D&C red #27 aluminum lake, D&C red #30 aluminum lake, dextrates hydrated, FD&C red #40 aluminum lake, flavor, magnesium stearate, microcrystalline cellulose, silicon dioxide, starch, sucralose, tribasic calcium phosphate.

Questions?

OTC - QUESTIONS SECTION

call toll free 1-844-912-4012

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
314221	simethicone 125 MG Chewable Tablet	PSN	1
314221	simethicone 125 MG Chewable Tablet	SCD	1

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
cb89b86a-369e-4204-8910-ae797c503af3	Product name	1	20230706
d4880ace-a516-8c47-8dfd-73a4ba5887d7	Product name	2	20180830
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
37835-233-18	EXTRA STRENGTH SIMETHICONE	2 in 1 CARTON	TABLET, CHEWABLE	2		1
37835-233-18	EXTRA STRENGTH SIMETHICONE	9 in 1 BLISTER PACK	TABLET, CHEWABLE	9		1

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

EXTRA STRENGTH SIMETHICONE
Simethicone
CROSPOVIDONE
D&C RED NO. 27 ALUMINUM LAKE
D&C RED NO. 30 ALUMINUM LAKE
DEXTROSE MONOHYDRATE
FD&C RED NO. 40 ALUMINUM LAKE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
SILICON DIOXIDE
STARCH, CORN
SUCRALOSE
TRIBASIC CALCIUM PHOSPHATE
DIMETHICONE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
37835-233	37835-233-18

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
CROSPOVIDONE	2S7830E561	IACT
D&C RED NO. 27 ALUMINUM LAKE	ZK64F7XSTX	IACT
D&C RED NO. 30 ALUMINUM LAKE	GE75M6YV5W	IACT
DEXTROSE MONOHYDRATE	LX22YL083G	IACT
FD&C RED NO. 40 ALUMINUM LAKE	6T47AS764T	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
MICROCRYSTALLINE CELLULOSE	OP1R32D61U	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
STARCH, CORN	O8232NY3SJ	IACT
SUCRALOSE	96K6UQ3ZD4	IACT
TRIBASIC CALCIUM PHOSPHATE	91D9GV0Z28	IACT
DIMETHICONE	92RU3N3Y1O	ACTIB

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
3f233e89-722c-cc0c-e063-6394a90addde			c1b88a30-ffeb-431c-ab73-728cdc786de0	2025-09-01	Warnings	Exact identifier spl id: 3f233e89-722c-cc0c-e063-6394a90addde spl set id: c1b88a30-ffeb-431c-ab73-728cdc786de0

Reported adverse events (FAERS/openFDA)#

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