Simethicone 125 mg soft gelatin capsules

Manufacturer: KROGER COMPANY | TIME CAP LABORATORIES, INC. | MARKSANS PHARMA LIMITED
Effective date: 2026-04-29
Label type: HUMAN OTC DRUG LABEL
Version: 4
Source: full-release
Hydrated at: 2026-06-01 01:55:30

Label at a glance#

ProductExtra strength gas relief

Active ingredientDIMETHICONE

Label structure10 sections

Dosage and administration

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

Contacts and useful links#

PhoneLabel contact1-800-632-6900

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each softgel)

Simethicone 125 mg

Purpose

OTC - PURPOSE SECTION

Purpose

Anti-gas

Use

INDICATIONS & USAGE SECTION

Use for the relief of

pressure, bloating and fullness commonly referred to as gas

Warning

WARNINGS SECTION

Warning

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Directions

DOSAGE & ADMINISTRATION SECTION

Directions

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

Other information

OTHER SAFETY INFORMATION

Other information

store at room temperature
protect from light, heat and moistur e

Inactive ingredients

INACTIVE INGREDIENT SECTION

Inactive ingredients

D&C Yellow 10, FD&C Red #40, FD&C Blue 1, gelatin, glycerol, medium chain triglyceride, peppermint oil, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

Questions or comments? Call 1-800-632-6900

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

simethicone-carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
198852	simethicone 125 MG Oral Capsule	PSN	4
198852	simethicone 125 MG Oral Capsule	SCD	4
198852	dimethicone 125 MG Oral Capsule	SY	4

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
41226-722-30	2025-02-11	C162847	48780-1	2cef2736-a59e-d83d-e063-dadaa90ab31f	Simethicone 125 mg soft gelatin capsules
41226-722-30	2025-01-30	C162847	48780-1	2cef2736-a59e-d83d-e063-dadaa90ab31f	Simethicone 125 mg soft gelatin capsules

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
41226-722-30	Extra strength gas relief	2 in 1 CARTON	CAPSULE	2		4
41226-722-30	Extra strength gas relief	15 in 1 BLISTER PACK	CAPSULE	15		4

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

Extra strength gas relief
Simethicone
D&C YELLOW NO. 10
FD&C BLUE NO. 1
MEDIUM-CHAIN TRIGLYCERIDES
PEPPERMINT OIL
PROPYLENE GLYCOL
SHELLAC
SORBITOL SOLUTION
GELATIN
GLYCERIN
WATER
TITANIUM DIOXIDE
FD&C RED NO. 40
DIMETHICONE
SORBITAN

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
41226-722	41226-722-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
D&C YELLOW NO. 10	35SW5USQ3G	IACT
FD&C BLUE NO. 1	H3R47K3TBD	IACT
MEDIUM-CHAIN TRIGLYCERIDES	C9H2L21V7U	IACT
PEPPERMINT OIL	AV092KU4JH	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
SHELLAC	46N107B71O	IACT
SORBITOL SOLUTION	8KW3E207O2	IACT
GELATIN	2G86QN327L	IACT
GLYCERIN	PDC6A3C0OX	IACT
WATER	059QF0KO0R	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
FD&C RED NO. 40	WZB9127XOA	IACT
DIMETHICONE	92RU3N3Y1O	ACTIB
SORBITAN	6O92ICV9RU	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
Extra strength gas relief	SIMETHICONE	KROGER COMPANY	ea1c7b4c-91a1-0c1c-e053-2995a90ab823	2026-04-29	Warnings	Exact identifier ndc (package): 41226-722-30 ndc (product): 41226-722 ndc11 (package): 41226072230 spl id: 50970506-5e42-37f7-e063-6294a90a3880 spl set id: ea1c7b4c-91a1-0c1c-e053-2995a90ab823

Reported adverse events (FAERS/openFDA)#

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