Simethicone 125 mg

Manufacturer: ATLANTIC BIOLOGICALS CORP.
Effective date: 2025-06-27
Label type: HUMAN OTC DRUG LABEL
Version: 4
Source: full-release
Hydrated at: 2026-06-01 01:06:06

Label at a glance#

ProductSimethicone 125 mg

Active ingredientDIMETHICONE

Label structure12 sections

Dosage and administration

thoroughly chew 1-2 tablets as needed after meals and at bedtime do not take more than 4 tablets per day

Storage and handling

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

Contacts and useful links#

PhoneLabel contact1-800-509-7592

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each chewable tablet)

OTC - ACTIVE INGREDIENT SECTION

Simethicone 125 mg

OTC - PURPOSE SECTION

Antiflatulent

Use

INDICATIONS & USAGE SECTION

relieves bloating, pressure and fullness commonly referred to as gas

Warnings

WARNINGS SECTION

Keep out of reach of children

TAMPER EVIDENT: DO NOT USE IF SAFETY POUCH LOOKS TO BE TEMPERED OR OPEN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

Directions

DOSAGE & ADMINISTRATION SECTION

thoroughly chew 1-2 tablets as needed after meals and at bedtime
do not take more than 4 tablets per day

Other information

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

compressible sugar, dextrose, maltodextrin, microcrystaline cellulose, peppermint flavor, silicon dioxide, sorbitol, stearic acid

How Supplied

HOW SUPPLIED SECTION

NDC 17856-0137-01

Box of 100 Chewable Tablets.................................. 17856-0137-01

ANTIFLATULENT

Questions or comments?

OTC - QUESTIONS SECTION

Distributed by:

ATLANTIC BIOLOGICALS CORP.

MIAMI, FL 33179

Call 1-800-509-7592

M-F 8 am - 5 pm EST

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	4
314221	simethicone 125 MG Chewable Tablet	SCD	4

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
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
17856-0137-1	2025-04-03	C162847	48780-1	1030e364-fccf-111a-e063-dadaa90a10e2	Simethicone 125 mg
17856-0137-1	2024-01-30	C162847	48780-1	1030e364-fccf-111a-e063-dadaa90a10e2	Simethicone 125 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
17856-0137-1	Simethicone 125 mg	100 in 1 BOX, UNIT-DOSE	TABLET, CHEWABLE	100	4
17856-0137-1	Simethicone 125 mg	1 in 1 POUCH	TABLET, CHEWABLE	1	4
17856-0137-2	Simethicone 125 mg	1 in 1 POUCH	TABLET, CHEWABLE	1	4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69618-032-06	EA - Each	69618-032	aa923b1b-9112-453b-bc6f-c3e2956863ec	1	2016-06-14

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

Simethicone 125 mg
Simethicone
SUCROSE
MALTODEXTRIN
PEPPERMINT
SORBITOL
STEARIC ACID
DEXTROSE
CELLULOSE, MICROCRYSTALLINE
SILICON DIOXIDE
DIMETHICONE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
17856-0137	17856-0137-1, 17856-0137-2
69618-032

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
SUCROSE	C151H8M554	IACT
MALTODEXTRIN	7CVR7L4A2D	IACT
PEPPERMINT	V95R5KMY2B	IACT
SORBITOL	506T60A25R	IACT
STEARIC ACID	4ELV7Z65AP	IACT
DEXTROSE	IY9XDZ35W2	IACT
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Simethicone 125 mg	SIMETHICONE	ATLANTIC BIOLOGICALS CORP.	4ce98db3-c7a6-4627-88c5-9de302a53188	2025-06-27	Warnings	Exact identifier ndc (package): 17856-0137-2 ndc (package): 17856-0137-1 ndc (product): 17856-0137 ndc11 (package): 17856013702 ndc11 (package): 17856013701 spl id: 38930d1f-1f60-1fa5-e063-6394a90a5c21 spl set id: 4ce98db3-c7a6-4627-88c5-9de302a53188
Simethicone 125 mg	SIMETHICONE	Reliable 1 Laboratires LLC	330aed4b-7109-09b8-e054-00144ff8d46c	2025-01-15	Warnings	Exact identifier ndc (product): 69618-032

Reported adverse events (FAERS/openFDA)#

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