FDA.reportPublic FDA data

CVS Simethicone Gas Relief 100 Chewable Tablets

Manufacturer
CVS
Effective date
2026-08-13
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
daily-update
Hydrated at
2026-08-18 02:01:58

Label at a glance#

ProductCVS PHARMACY Gas relief
Active ingredientDIMETHICONE, UNSPECIFIED
Label structure8 sections

Indications and uses

relieves: • bloating & discomfort • gas distress

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 6 tablets in 24 hours period except under the advice and supervision of a physician.

Storage and handling

• each tablet contains: calcium 60 mg • store at room temperature

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Simethicone 80 mg

Purpose

OTC - PURPOSE SECTION

Antigas

Uses

INDICATIONS & USAGE SECTION

relieves:

  • bloating & discomfort
  • gas distress

Warnings

WARNINGS SECTION

Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center immediately at 1-800-222-1222.

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 6 tablets in 24 hours period except under the advice and supervision of a physician.

Other information

STORAGE AND HANDLING SECTION

  • each tablet contains: calcium 60 mg
  • store at room temperature

Inactive ingredients

INACTIVE INGREDIENT SECTION

dextrose, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, silica, tribasic calcium phosphate

Questions or comments?

OTC - QUESTIONS SECTION

1-866-467-2748

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 51316-111-00

Gas Relief

Simethicone 80 mg / Antigas

For Fast Relief of Gas Distress Bloating & Discomfort

Mint Flavor

Naturally and Artificially Flavored

100 CHEWABLE TABLETS

Distributed by

CVS Simethicone 100 Chewable Tablets
CVS Simethicone 100 Chewable Tablets

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51316-11151316-111-00

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
NameUNIIKind
DIMETHICONE, UNSPECIFIED92RU3N3Y1OACTIB
DEXTROSE, UNSPECIFIED FORMIY9XDZ35W2IACT
MAGNESIUM STEARATE70097M6I30IACT
MALTODEXTRIN7CVR7L4A2DIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
TRICALCIUM PHOSPHATEK4C08XP666IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
52025-12-08full-release2026-06-01 01:20:43

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 Gas reliefSIMETHICONECVSc2a3a978-c957-4453-88b3-53f4e80a24652026-08-13WarningsExact identifier
ndc (package): 51316-111-00
ndc (product): 51316-111
ndc11 (package): 51316011100
spl id: eaa66539-08b1-4562-933e-bdadde04ad23
spl set id: c2a3a978-c957-4453-88b3-53f4e80a2465

Reported adverse events (FAERS/openFDA)#

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