FDA.reportPublic FDA data

Gas Relief SIMETHICONE 250 mg Anti-gas

Manufacturer
CVS Pharmacy, Inc. | USpharma Ltd
Effective date
2025-02-06
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:54:38

Label at a glance#

ProductGas Relief SIMETHICONE 250 mg Anti-gas
Active ingredientDIMETHICONE
Label structure9 sections

Indications and uses

for the relief of pressure, bloating, and fullness commonly referred to as gas

Dosage and administration

adults and children 12 years and older: take 1 or 2 chewables as needed after meals and at bedtime. do not exceed 2 chewables in 24 hours except under the advice and supervision of a physician.

Label contents#

Full prescribing information#

Active ingredient (in each chewable)

OTC - ACTIVE INGREDIENT SECTION

Simethicone, 250 mg

Purpose

OTC - PURPOSE SECTION

Antigas

Uses

INDICATIONS & USAGE SECTION

for the relief of

  • pressure, bloating, and fullness commonly referred to as gas

Warnings

WARNINGS SECTION

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental overdose, seek professional assistance or contact a poison control center immediately.

SPL UNCLASSIFIED SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 12 years and older: take 1 or 2 chewables as needed after meals and at bedtime.
  • do not exceed 2 chewables in 24 hours except under the advice and supervision of a physician.

SPL UNCLASSIFIED SECTION

Other information

  • each chewable contains: potassium 5 mg, sodium 5 mg. 

very low sodium

  • store at controlled room temperature 20-25°C (68-77°F).
  • protect from light, heat and moisture.
  • Child Resistant Container; do not use if printed seal under cap is broken or missing.

Inactive ingredients:

INACTIVE INGREDIENT SECTION

carnauba wax, citric acid, croscarmellose sodium, crospovidone, D&C red #30 aluminum lake, flavors, glucose syrup, glycerin, gum arabic, maltitol solution,mannitol, powdered milk, propylene glycol, sorbitol, starch, sucralose, sucrose.

SPL UNCLASSIFIED SECTION

Questions or comments?

Call 1-800-227-6151

Principal display Panel-250 mg label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CVS Health Compare to the active ingredient in Gas-X ®*

NDC 51316-702-12

Gas Relief

SIMETHICONE, 250 mg

Anti-gas

Fast Relief of:

Bloating, Pressure &
Gas discomfort


Actual Size    Mixed Berry Flavor

30 SOFT CHEWABLES

CVS Gas Relief LabelCVS Gas Relief Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2595235simethicone 250 MG Chewable TabletPSN4
2595235simethicone 250 MG Chewable TabletSCD4

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIMETHICONE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51316-702-08Gas Relief SIMETHICONE 250 mg Anti-gas20 in 1 BOTTLE, PLASTICTABLET, CHEWABLE204
51316-702-12Gas Relief SIMETHICONE 250 mg Anti-gas30 in 1 BOTTLE, PLASTICTABLET, CHEWABLE304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51316-702GAS RELIEF SIMETHICONE 250 MG ANTI-GAS (SIMETHICONE) TABLET, CHEWABLE [CVS PHARMACY, INC.]4Current NDC, Legacy NDC, 2 package rows20250209_63dbc39e-2ba8-4435-9093-d1ad2eb3e8d5.zip

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51316-70251316-702-12, 51316-702-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
MANNITOL3OWL53L36AIACT
MILK PROTEIN CONCENTRATE871QYF3I7BIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SORBITOL506T60A25RIACT
STARCH, CORNO8232NY3SJIACT
SUCRALOSE96K6UQ3ZD4IACT
SUCROSEC151H8M554IACT
DIMETHICONE92RU3N3Y1OACTIB
CARNAUBA WAXR12CBM0EIZIACT
MALTITOLD65DG142WKIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
CROSPOVIDONE2S7830E561IACT
D&C RED NO. 30 ALUMINUM LAKEGE75M6YV5WIACT
CORN SYRUP9G5L16BK6NIACT
GLYCERINPDC6A3C0OXIACT
ACACIA5C5403N26OIACT

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Gas Relief SIMETHICONE 250 mg Anti-gasSIMETHICONECVS Pharmacy, Inc.63dbc39e-2ba8-4435-9093-d1ad2eb3e8d52025-02-06WarningsExact identifier
ndc (package): 51316-702-08
ndc (package): 51316-702-12
ndc (product): 51316-702
ndc11 (package): 51316070212
ndc11 (package): 51316070208
spl id: 2d80f49f-9771-a7d4-e063-6394a90a26de
spl set id: 63dbc39e-2ba8-4435-9093-d1ad2eb3e8d5

Reported adverse events (FAERS/openFDA)#

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