Premier Value

Manufacturer: PHARMACY VALUE ALLIANCE, LLC
Effective date: 2024-10-28
Label type: HUMAN OTC DRUG LABEL
Version: 6
Source: full-release
Hydrated at: 2026-06-01 00:31:26

Label at a glance#

ProductPremier Value Extra Strength

Active ingredientDIMETHICONE, UNSPECIFIED

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 as needed after meals and at bedtime. • do not exceed 4 tablets in a 24 hours 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

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 as needed after meals and at bedtime.
do not exceed 4 tablets in a 24 hours 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

Premier Value^®

NDC 68016-811-18

*Compare to the active ingredient in Gas-X^® Extra Strength

Extra Strength

Gas Relief

Antigas/Simethicone 125 mg

Relieves:

Pressure
Bloating
Discomfort

Cherry Creme Flavor

Naturally and Artificially Flavored

18 CHEWABLE TABLETS

K PAREVE

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

Distributed by:

Pharmacy Value Alliance, LLC

407 East Lancaster Avenue,

Wayne, PA 19087

IMPORTANT: Keep this carton for future reference on full labeling.

Premier Value Extra Strength Simethicone

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
314221	simethicone 125 MG Chewable Tablet	PSN	6
314221	simethicone 125 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68016-811-18	Premier ValueExtra Strength	9 in 1 BLISTER PACK	TABLET, CHEWABLE	9		6
68016-811-18	Premier ValueExtra Strength	2 in 1 CARTON	TABLET, CHEWABLE	2		6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68016-811	PREMIER VALUE EXTRA STRENGTH (SIMETHICONE) TABLET, CHEWABLE [PHARMACY VALUE ALLIANCE, LLC]	6	Current NDC, Legacy NDC, 2 package rows	20241030_df2b1b62-5bd2-4d02-86c2-537b965a8d20.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

Premier Value Extra Strength
Simethicone
DIMETHICONE, UNSPECIFIED
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
68016-811	68016-811-18

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, UNSPECIFIED	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
Premier Value Extra Strength	SIMETHICONE	PHARMACY VALUE ALLIANCE, LLC	df2b1b62-5bd2-4d02-86c2-537b965a8d20	2024-10-28	Warnings	Exact identifier ndc (package): 68016-811-18 ndc (product): 68016-811 ndc11 (package): 68016081118 spl id: a73731e6-56d7-43a9-8623-dc9859be4f38 spl set id: df2b1b62-5bd2-4d02-86c2-537b965a8d20

Reported adverse events (FAERS/openFDA)#

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