FDA.reportPublic FDA data

SIMETHICONE CAPSULES 250 mg, liquid filled

Manufacturer
CVS PHARMACY, INC. | Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.
Effective date
2016-12-13
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:48:10

Label at a glance#

ProductMaximum Strength Gas Relief
Active ingredientDIMETHICONE
Label structure9 sections

Dosage and administration

swallow one or two softgels after a meal do not exceed two softgels per 24 hours except under the advice and supervision of a physician

Storage and handling

store at room temperature 59°-86°F (15°-30°C)

Label contents#

Full prescribing information#

Active ingredient (in each softgel)

OTC - ACTIVE INGREDIENT SECTION

Simethicone 250 mg

Purpose

OTC - PURPOSE SECTION

Anti-gas

Use

INDICATIONS & USAGE SECTION

  • relieves bloating, pressure or fullness commonly referred to as gas

Warnings

WARNINGS SECTION

Stop use and ask a doctor if

OTC - STOP USE SECTION

condition persists

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Directions

DOSAGE & ADMINISTRATION SECTION

  • swallow one or two softgels after a meal
  • do not exceed two softgels per 24 hours except under the advice and supervision of a physician

Other information

STORAGE AND HANDLING SECTION

  • store at room temperature 59°-86°F (15°-30°C)

Inactive ingredients

INACTIVE INGREDIENT SECTION

D&C red #33, FD&C blue #1, gelatin, glycerin, purified water, and white edible ink

Questions or Comments?

OTC - QUESTIONS SECTION

Call toll free: 1-855-215-8180

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CVS MAXIMUM STRENGTH GAS RELIEF

SIMETHICONE 250 mg

Anti-gas

NDC 69842-068-04

Compare to the active ingredient in PHAZYME® Maximum Strength

24 Liquid-Filled SoftGels

simethicone 24ctsimethicone 24ct

CVS MAXIMUM STRENGTH GAS RELIEF

SIMETHICONE 250 mg

Anti-gas

NDC 69842-068-22

Compare to the active ingredient in PHAZYME® Maximum Strength

60 Liquid-Filled SoftGels

simethicone 60ctsimethicone 60ct

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
412111simethicone 250 MG Oral CapsulePSN1
412111simethicone 250 MG Oral CapsuleSCD1
412111dimethicone 250 MG Oral CapsuleSY1

DailyMed Pharmacologic Classes#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69842-068-042025-01-30C16284748780-12cef2736-abed-d83d-e063-dadaa90ab31fSIMETHICONE CAPSULES 250 mg, liquid filled
69842-068-222025-01-30C16284748780-12cef2736-abed-d83d-e063-dadaa90ab31fSIMETHICONE CAPSULES 250 mg, liquid filled

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69842-068-04Maximum Strength Gas Relief2 in 1 CARTONCAPSULE, LIQUID FILLED21
69842-068-04Maximum Strength Gas Relief12 in 1 BLISTER PACKCAPSULE, LIQUID FILLED121
69842-068-22Maximum Strength Gas Relief1 in 1 CARTONCAPSULE, LIQUID FILLED11
69842-068-22Maximum Strength Gas Relief60 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-068MAXIMUM STRENGTH GAS RELIEF (SIMETHICONE) CAPSULE, LIQUID FILLED [CVS PHARMACY, INC.]1Legacy NDC, 4 package rows20161214_43126f66-e90b-4de9-bb6f-3240de4f2ba6.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69842-06869842-068-04, 69842-068-22

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIMETHICONE92RU3N3Y1OACTIB
D&C RED NO. 339DBA0SBB0LIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT

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
baf4d896-375c-41e3-926f-739f09d72d8443126f66-e90b-4de9-bb6f-3240de4f2ba62016-12-13WarningsExact identifier
spl id: baf4d896-375c-41e3-926f-739f09d72d84
spl set id: 43126f66-e90b-4de9-bb6f-3240de4f2ba6

Reported adverse events (FAERS/openFDA)#

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