extra strength gas relief

Manufacturer: QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)
Effective date: 2021-01-21
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-05-31 23:37:11

Label at a glance#

Productextra strength gas relief cherry creme flavored

Active ingredientDIMETHICONE

Label structure8 sections

Indications and uses

For the relief of • Pressure, bloating and fullness commonly referred to as gas

Dosage and administration

• adults : chew 1 to 2 tablets completely as needed after meals and at bedtime. Do not swallow tablets whole. • do not exceed 4 tablets in a 24 hour period except under the advice and supervision of a physician.

Storage and handling

• each tablets contains: calcium 45 mg • store at room temperature • protect from excessive heat and moisture DO NOT USE IF ANY INDVIDUAL BLISTER IS BROKEN OR OPEN

Contacts and useful links#

PhoneLabel contact248-449-9300

Websitewww.qualitychoice.com

www.qualitychoice.com

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Simethicone 125 mg

Purpose

OTC - PURPOSE SECTION

Anti-gas

Uses

INDICATIONS & USAGE SECTION

For the relief of

Pressure, bloating and fullness commonly referred to as gas

Warning

WARNINGS SECTION

Keep Out of Reach of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

adults: chew 1 to 2 tablets completely as needed after meals and at bedtime. Do not swallow tablets whole.
do not exceed 4 tablets in a 24 hour period except under the advice and supervision of a physician.

Other information

STORAGE AND HANDLING SECTION

each tablets contains: calcium 45 mg
store at room temperature
protect from excessive heat and moisture

DO NOT USE IF ANY INDVIDUAL BLISTER IS BROKEN OR OPEN

Inactive ingredients

INACTIVE INGREDIENT SECTION

D & C Red No. 30, dextrose, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, silicon dioxide, sucralose, tribasic calcium phosphate

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

QC_®QUALITY CHOICE

NDC 63868-854-18

*Compare to the Active Ingredient in Gas-X^® Extra Strength

Gas Relief

Extra Strength, Simethicone 125 mg

Relieves:

Discomfort

Pressure

Bloating

Cherry Creme Flavored Chews

Naturally and Artificially Flavored

*This product is not manufactured or distributed by GSK Consumer Healthcare, Inc. the distributor of Gas-X^® Extra strength.

100% QC SATISFACTION GURANTEED

Distributed by C.D.M.A., Inc.© 43157 W 9 Mile Rd Novi, MI 48375

www.qualitychoice.com

Questions: 248-449-9300

EXTRA STRENGTH SIMETHICONE 125 MG CHERRY CREME FLAVORED

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
314221	simethicone 125 MG Chewable Tablet	PSN	2
314221	simethicone 125 MG Chewable Tablet	SCD	2

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
63868-854-18	2023-01-30	C162847	48780-1	f386c64a-1e37-0266-e053-dadaa90a7c1a	QUALITY CHOICE Extra Strength Gas Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63868-854-18	extra strength gas reliefcherry creme flavored	2 in 1 CARTON	TABLET, CHEWABLE	2		2
63868-854-18	extra strength gas reliefcherry creme flavored	9 in 1 BLISTER PACK	TABLET, CHEWABLE	9		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63868-854	EXTRA STRENGTH GAS RELIEF CHERRY CREME FLAVORED (SIMETHICONE) TABLET, CHEWABLE [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]	2	Legacy NDC, 2 package rows	20210122_cbd3c114-9402-4cd7-bfd3-46356bc67389.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63868-854-18	EA - Each	63868-854	ff66fff7-21e2-4701-8fb1-5b9a5cd3b51b	1	2022-08-04

Products#

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

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

extra strength gas relief cherry creme flavored
simethicone
DIMETHICONE
D&C RED NO. 30
DEXTROSE, UNSPECIFIED FORM
MAGNESIUM STEARATE
MALTODEXTRIN
MICROCRYSTALLINE CELLULOSE
SILICON DIOXIDE
SUCRALOSE
TRIBASIC CALCIUM PHOSPHATE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
63868-854	63868-854-18

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
DIMETHICONE	92RU3N3Y1O	ACTIB
D&C RED NO. 30	2S42T2808B	IACT
DEXTROSE, UNSPECIFIED FORM	IY9XDZ35W2	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
MALTODEXTRIN	7CVR7L4A2D	IACT
MICROCRYSTALLINE CELLULOSE	OP1R32D61U	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
SUCRALOSE	96K6UQ3ZD4	IACT
TRIBASIC CALCIUM PHOSPHATE	91D9GV0Z28	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
7c36abaa-6f2b-416e-9e80-a74758a2f5ff			cbd3c114-9402-4cd7-bfd3-46356bc67389	2021-01-21	Warnings	Exact identifier spl id: 7c36abaa-6f2b-416e-9e80-a74758a2f5ff spl set id: cbd3c114-9402-4cd7-bfd3-46356bc67389

Reported adverse events (FAERS/openFDA)#

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