SIMETHICONE

Manufacturer: ATLANTIC BIOLOGICALS CORP. | UNIT DOSE SOLUTIONS
Effective date: 2022-05-19
Label type: HUMAN OTC DRUG LABEL
Version: 6
Source: full-release
Hydrated at: 2026-05-31 23:49:39

Label at a glance#

ProductSIMETHICONE

Active ingredientDIMETHICONE

Label structure9 sections

Indications and uses

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

Dosage and administration

chew or crush tablet completely before swallowing adults and children 12 years and over: take 1-2 tablets as needed after meals and at bedtime. Do not exceed 6 tablets in 24 hours except under the advice and supervision of a doctor. children under 12 years: ask a doctor

Storage and handling

each tablet contains: calcium 65 mg Tamper Evident: Do not use if imprinted seal under cap is missing or broken store at room temperature, 15°C - 30°C (59˚F - 86˚F) protect from moisture

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Simethicone 80 mg

Purpose

OTC - PURPOSE SECTION

Anti-Gas

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

If pregnant or breast feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Directions

DOSAGE & ADMINISTRATION SECTION

chew or crush tablet completely before swallowing
adults and children 12 years and over: take 1-2 tablets as needed after meals and at bedtime.

Do not exceed 6 tablets in 24 hours except under the advice and supervision of a doctor.

children under 12 years: ask a doctor

Other information

STORAGE AND HANDLING SECTION

each tablet contains: calcium 65 mg
Tamper Evident: Do not use if imprinted seal under cap is missing or broken
store at room temperature, 15°C - 30°C (59˚F - 86˚F)
protect from moisture

Inactive ingredients

INACTIVE INGREDIENT SECTION

cellulose, corn starch, crospovidone, dextrates hydrated, flavor,
magnesium stearate, silica, sucralose, calcium phosphate.

Questions or comments?

OTC - QUESTIONS SECTION

DISTRIBUTED BY:

ATLANTIC BIOLOGICALS CORP.

MIAMI, FL 33179

package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
314216	simethicone 80 MG Chewable Tablet	PSN	6
314216	simethicone 80 MG Chewable Tablet	SCD	6

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
17856-0791-1	2024-01-30	C162847	48780-1	1030e365-6e80-111a-e063-dadaa90a10e2	gc 791

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
17856-0791-1	SIMETHICONE	50 in 1 BOX	TABLET, CHEWABLE	50		6
17856-0791-2	SIMETHICONE	1 in 1 POUCH	TABLET, CHEWABLE	1		6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
17856-0791	SIMETHICONE TABLET, CHEWABLE [ATLANTIC BIOLOGICALS CORP.]	6	Legacy NDC, 2 package rows	20220520_e07aebe8-3c58-4bf0-9e80-66d430e2de9b.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
57896-791-01	EA - Each	57896-791	d7abb991-f273-4ad8-8ac3-e1239c002ec0	1	2014-12-01
57896-791-08	EA - Each	57896-791	c9e325d9-2782-4318-861b-0e093f6d3dfd	1	2022-02-07

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

SIMETHICONE
CELLULOSE, MICROCRYSTALLINE
DEXTRATES
SILICON DIOXIDE
TRICALCIUM PHOSPHATE
DIMETHICONE
STARCH, CORN
CROSPOVIDONE
MAGNESIUM STEARATE
SUCRALOSE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
17856-0791	17856-0791-2, 17856-0791-1
57896-791

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
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
DEXTRATES	G263MI44RU	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
TRICALCIUM PHOSPHATE	K4C08XP666	IACT
DIMETHICONE	92RU3N3Y1O	ACTIB
STARCH, CORN	O8232NY3SJ	IACT
CROSPOVIDONE	2S7830E561	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
SUCRALOSE	96K6UQ3ZD4	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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SIMETHICONE	SIMETHICONE	Geri-Care Pharmaceuticals, Corp	be96ce05-dd74-4915-9a8f-2a1b34e2f158	2025-11-17	Warnings	Exact identifier ndc (product): 57896-791
44ad7d45-f84b-4866-a7f4-806a71baa104			e07aebe8-3c58-4bf0-9e80-66d430e2de9b	2022-05-19	Warnings	Exact identifier spl id: 44ad7d45-f84b-4866-a7f4-806a71baa104 spl set id: e07aebe8-3c58-4bf0-9e80-66d430e2de9b

Reported adverse events (FAERS/openFDA)#

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