FDA.reportPublic FDA data

CVS Extra Strength Gas Relief Tablets

Manufacturer
CVS
Effective date
2026-08-13
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
daily-update
Hydrated at
2026-08-18 02:02:35

Label at a glance#

ProductCVS PHARMACY Extra Strength Gas Relief
Active ingredientDIMETHICONE, UNSPECIFIED
Label structure8 sections

Dosage and administration

▪ adults and children 12 years and older: 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 tablet contains: calcium 45 mg ▪ store at room temperature ▪ protect from moisture

Label contents#

Full prescribing information#

Active Ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Simethicone 125 mg

PURPOSE

OTC - PURPOSE SECTION

Anti-gas

Use

INDICATIONS & USAGE SECTION

For the relief of:

  • Pressure, bloating and fullness commonly referred to as gas

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 12 years and older: 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 tablet contains: calcium 45 mg
  • store at room temperature
  • protect from moisture

Inactive Ingredients

INACTIVE INGREDIENT SECTION

D&C yellow # 10, dextrose, flavors, magnesium stearate, microcrystalline cellulose, silicon dioxide, sucralose, tribasic calcium phosphate

Questions or comments

OTC - QUESTIONS SECTION

1-866-467-2748

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

*Compare to the active ingredient in Gas-X Extra Strength
NDC 51316-011-18
Extra strength
Gas Relief
Simethicone 125 mg/Anti-Gas
Fast Relief of Pressure, Bloating & Discomfort


Peppermint Flavor

Naturally and Artificially Flavored

18 Chewable Tablets

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

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


CVS Extra Strength Gas Relief 18 Chewable Tablets
CVS Extra Strength Gas Relief 18 Chewable Tablets

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51316-01151316-011-18

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
NameUNIIKind
DIMETHICONE, UNSPECIFIED92RU3N3Y1OACTIB
D&C YELLOW NO. 1035SW5USQ3GIACT
DEXTROSE, UNSPECIFIED FORMIY9XDZ35W2IACT
MAGNESIUM STEARATE70097M6I30IACT
MALTODEXTRIN7CVR7L4A2DIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SUCRALOSE96K6UQ3ZD4IACT
TRIBASIC CALCIUM PHOSPHATE91D9GV0Z28IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
52025-12-08full-release2026-06-01 01:20:42

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CVS PHARMACY Extra Strength Gas ReliefSIMETHICONE ANTIGASCVSb0fc2f24-cd63-4bb2-b9bb-a73449bcc1692026-08-13WarningsExact identifier
ndc (package): 51316-011-18
ndc (product): 51316-011
ndc11 (package): 51316001118
spl id: 078cc154-b97f-4843-a119-22283d31560f
spl set id: b0fc2f24-cd63-4bb2-b9bb-a73449bcc169

Reported adverse events (FAERS/openFDA)#

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