Simethicone Anti-Gas 80 mg Tablet

Manufacturer: Cardinal Health
Effective date: 2018-12-21
Label type: HUMAN OTC DRUG LABEL
Version: 5
Source: legacy-cache
Hydrated at: 2026-08-02 00:34:28

Label at a glance#

ProductSimethicone

Active ingredientDIMETHICONE

Label structure9 sections

Indications and uses

Relieves pressure, bloating, and symptoms referred to as gas.

Dosage and administration

Chew one or two tablets thoroughly as needed after meals and at bedtime.

Storage and handling

STORE at Room Temperature. Avoid high humidity and excessive heat, above 40 C (104 F). Mint Flavored chewable Tablets Sky Mfg. By: Guardian Drug Company 2 Charles Court Dayton, NJ 08810 Distributed By McKesson Packaging Services a business unit of McKesson Corporation 7101 Weddington Road Concord, NC 28027 Validated with McKesson's PROmanager-Rx Automated storage & dispensing system for Package-Ready Oral solids w...

Contacts and useful links#

Websitewww.promanager-rx.com

www.PROmanager-Rx.com

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Each tablet contains 80 mg Simethicone

Mint Flavored chewable tablets

Purpose

OTC - PURPOSE SECTION

Anti-gas

Keep Out of Reach of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Uses

INDICATIONS & USAGE SECTION

Relieves pressure, bloating, and symptoms referred to as gas.

Warnings

WARNINGS SECTION

This package is intended for institutional use only.

Do not exceed six tablets in a 24 hour period except under the advice and supervision of a physician.

In case of overdose get medical help or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

Chew one or two tablets thoroughly as needed after meals and at bedtime.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Compressible sugar, dextrose, flavor, magnesium stearate, maltodextrin and sorbitol.

Storage

STORAGE AND HANDLING SECTION

STORE at Room Temperature. Avoid high humidity and excessive heat, above 40 C (104 F).

Mint Flavored chewable Tablets

Sky

Mfg. By: Guardian Drug Company

2 Charles Court

Dayton, NJ 08810

Distributed By

McKesson Packaging Services

a business unit of McKesson Corporation

7101 Weddington Road

Concord, NC 28027

Validated with McKesson's PROmanager-Rx Automated storage & dispensing system for Package-Ready Oral solids

www.PROmanager-Rx.com

Distributed by:

Cardinal Health

Dublin, OH 43017

L43456330318

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Simethicone Anti-Gas

80 mg Tablets

10 Tablets

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
55154-1480-0	2024-11-01	C162847	48780-1	ba0f9c33-0f2e-a910-e053-dadaa90a0b85	Simethicone Anti-Gas 80 mg Tablet
55154-1480-0	2021-01-29	C162847	48780-1	ba0f9c33-0f2e-a910-e053-dadaa90a0b85	Simethicone Anti-Gas 80 mg Tablet

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63739-225-02	EA - Each	63739-225	b1a10cec-24fc-4ab2-b282-7bb3918e6f81	1	2022-07-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
DIMETHICONE	ACTIVE INGREDIENT	92RU3N3Y1O	2
DIMETHICONE	ACTIVE MOIETY	92RU3N3Y1O	2
DEXTROSE	INACTIVE INGREDIENT	IY9XDZ35W2	2
MAGNESIUM	INACTIVE INGREDIENT	I38ZP9992A	2
MALTODEXTRIN	INACTIVE INGREDIENT	7CVR7L4A2D	2
SORBITOL	INACTIVE INGREDIENT	506T60A25R	2
STEARYL STEARATE	INACTIVE INGREDIENT	5WX2EGD0DK	2
SUCROSE	INACTIVE INGREDIENT	C151H8M554	2

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

Simethicone
DIMETHICONE
SUCROSE
DEXTROSE, UNSPECIFIED FORM
MAGNESIUM
STEARYL STEARATE
MALTODEXTRIN
SORBITOL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
55154-1480	55154-1480-0
63739-225

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
DIMETHICONE	92RU3N3Y1O	ACTIB
SUCROSE	C151H8M554	IACT
DEXTROSE, UNSPECIFIED FORM	IY9XDZ35W2	IACT
MAGNESIUM	I38ZP9992A	IACT
STEARYL STEARATE	5WX2EGD0DK	IACT
MALTODEXTRIN	7CVR7L4A2D	IACT
SORBITOL	506T60A25R	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 3 · 128 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
SORBITOL	SORBITOL	506T60A25R	PASTE / DENTAL	14.6 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
DEXTROSE	DEXTROSE	IY9XDZ35W2	TROCHE / ORAL	903.5 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SPRAY / NASAL		49 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
MALTODEXTRIN	MALTODEXTRIN	7CVR7L4A2D	POWDER, FOR SUSPENSION / ORAL		8000 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	AEROSOL, FOAM / TOPICAL	4.95 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	OINTMENT / TOPICAL	10 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	GUM, CHEWING / BUCCAL		5110 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
DEXTROSE	DEXTROSE	IY9XDZ35W2	INJECTION / INTRAMUSCULAR	5 %w/v		Exact identifier — unii candidate 21 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SYSTEM / TOPICAL		6300 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	SUPPOSITORY / RECTAL	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
DEXTROSE	DEXTROSE	IY9XDZ35W2	TABLET, EXTENDED RELEASE / ORAL	103.95 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	POWDER / ORAL		36000 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	INJECTION, SUSPENSION, LIPOSOMAL / INTRAVENOUS	9.4 %w/v		Exact identifier — unii candidate 48 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	CONCENTRATE / ORAL		4800 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	WAFER / ORAL	155.2 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	ELIXIR / ORAL		18000 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	TABLET, COATED / ORAL	516.42 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUS		308 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	TABLET, DELAYED RELEASE / ORAL	0.01 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	LIQUID / ORAL		53460 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	TABLET, FILM COATED, EXTENDED RELEASE / ORAL	119.12 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	LOZENGE / TRANSMUCOSAL		1255 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	CREAM / TOPICAL	36.8 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	POWDER, FOR SUSPENSION / ORAL		12000 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	CAPSULE, EXTENDED RELEASE / ORAL		619 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	CONCENTRATE / ORAL	600 mg/1ml		Exact identifier — unii candidate 44 equally ranked IID candidates
DEXTROSE	DEXTROSE	IY9XDZ35W2	INJECTION / INTRASPINAL	75 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
DEXTROSE	DEXTROSE	IY9XDZ35W2	TABLET, DELAYED RELEASE / ORAL	NA		Exact identifier — unii candidate 21 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	INJECTION / INTRALESIONAL	45 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	INJECTION, SOLUTION / SUBCUTANEOUS	4.7 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	TABLET, FILM COATED / ORAL		145 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	TABLET / ORAL	337.28 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
DEXTROSE	DEXTROSE	IY9XDZ35W2	CONCENTRATE / ORAL	400 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	INJECTION / INTRA-ARTICULAR	45 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
DEXTROSE	DEXTROSE	IY9XDZ35W2	TABLET, CHEWABLE / ORAL		1286 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SOLUTION / NASAL	25 mg/1ml		Exact identifier — unii candidate 44 equally ranked IID candidates
DEXTROSE	DEXTROSE	IY9XDZ35W2	POWDER / VAGINAL	430 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
DEXTROSE	DEXTROSE	IY9XDZ35W2	INJECTION / INTRAVENOUS	5 %w/v		Exact identifier — unii candidate 21 equally ranked IID candidates
MALTODEXTRIN	MALTODEXTRIN	7CVR7L4A2D	TABLET, EFFERVESCENT / ORAL		14404 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SOLUTION / OPHTHALMIC		6 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	TROCHE / BUCCAL	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
DEXTROSE	DEXTROSE	IY9XDZ35W2	INJECTION, SOLUTION / INTRAVENOUS	51.7 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
MALTODEXTRIN	MALTODEXTRIN	7CVR7L4A2D	SOLUTION / ORAL		1451 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	SYRUP / ORAL		46400 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	TABLET, EXTENDED RELEASE / ORAL		428 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	TABLET, CHEWABLE / ORAL		3555 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
MALTODEXTRIN	MALTODEXTRIN	7CVR7L4A2D	FILM, SOLUBLE / ORAL		19 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	POWDER, FOR SOLUTION / ORAL		38666 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	EMULSION / TOPICAL	7 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	INJECTION, SOLUTION / INTRAVENOUS	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	CAPSULE, DELAYED RELEASE / ORAL		955 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	POWDER / ORAL		27768 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SOLUTION / ORAL		29268 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
DEXTROSE	DEXTROSE	IY9XDZ35W2	SYRUP / ORAL	620 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
MALTODEXTRIN	MALTODEXTRIN	7CVR7L4A2D	PASTE / ORAL		1050 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	SUSPENSION, EXTENDED RELEASE / ORAL		5400 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	LOZENGE / BUCCAL	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL		18790 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SUSPENSION / RECTAL	46.18 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
MALTODEXTRIN	MALTODEXTRIN	7CVR7L4A2D	TABLET, ORALLY DISINTEGRATING / ORAL		12 mg	Exact identifier — unii candidate 15 equally ranked IID candidates

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
5360b91f-4508-4a67-aefc-207c324c9b81			d93ff75d-9cdb-476c-bb65-eabeefb91a34	2024-11-01	Warnings	Exact identifier spl set id: d93ff75d-9cdb-476c-bb65-eabeefb91a34

Reported adverse events (FAERS/openFDA)#

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