FDA.reportPublic FDA data

Maximum Strength Gas Relief Softgel-60ct

Manufacturer
HEB
Effective date
2024-12-16
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:51:15

Label at a glance#

ProductMaximum Strength Gas Relief Softgel-60ct
Active ingredientDIMETHICONE, UNSPECIFIED
Label structure10 sections

Indications and uses

relieves bloating, pressure or fullness commonly referred to as gas

Dosage and administration

Swallow one or two softgels as symptoms occur do not exceed 2 softgels per 24 hours except under the advice and supervision of a physician

Storage and handling

store at room temperature 20-25°C (68-77°F) protect from heat, humidity and light

Label contents#

Full prescribing information#

Active ingredient (in each softgel)

OTC - ACTIVE INGREDIENT SECTION

Simethicone 250 mg

Purpose

OTC - PURPOSE SECTION

Anti-gas

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Stop use and ask a doctor if condition persists.

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Swallow one or two softgels as symptoms occur
  • do not exceed 2 softgels per 24 hours except under the advice and supervision of a physician

Other information

STORAGE AND HANDLING SECTION

  • store at room temperature 20-25°C (68-77°F)
  • protect from heat, humidity and light

Inactive ingredients

INACTIVE INGREDIENT SECTION

D&C Red #33, edible ink, FD&C Blue #1, gelatin, glycerin, purified water

Questions or comments?

OTC - QUESTIONS SECTION

1-888-577-8033 Monday-Friday 8am-4pm EST

SPL UNCLASSIFIED SECTION

Compare to Maximum Strength Phazyme ® active ingredient*

Relieves:
• Bloating
• Pressure
• Fullness
Commonly Referred to as Gas

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS TORN, BROKEN OR SHOWS ANY SIGN OF TAMPERING.

READ AND KEEP OUTER CARTON FOR COMPLETE PRODUCT WARNINGS AND INFORMATION

MADE WITH PRIDE AND CARE FOR H-E-B®,
SAN ANTONIO, TEXAS 78204

Product of United Arab Emirates

100% GUARANTEE promise

If you aren't completely pleased with this product, we'll be happy to replace it or refund your money. You have our word on it.

*Phazyme® is a registered trademark of C.B. Fleet Company Inc.

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

gasrelief813gasrelief813

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
412111simethicone 250 MG Oral CapsulePSN3
412111simethicone 250 MG Oral CapsuleSCD3
412111dimethicone 250 MG Oral CapsuleSY3

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
37808-813-06Maximum Strength Gas Relief Softgel-60ct1 in 1 CARTONCAPSULE, LIQUID FILLED13
37808-813-06Maximum Strength Gas Relief Softgel-60ct60 in 1 BOTTLECAPSULE, LIQUID FILLED603

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37808-813MAXIMUM STRENGTH GAS RELIEF SOFTGEL-60CT (SIMETHICONE) CAPSULE, LIQUID FILLED [HEB]3Current NDC, 2 package rows20250109_f65e362a-2f90-428a-b885-eefdad8cae1e.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
37808-81337808-813-06

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
DIMETHICONE, UNSPECIFIED92RU3N3Y1OACTIB
D&C RED NO. 339DBA0SBB0LIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
GELATIN, UNSPECIFIED2G86QN327LIACT
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
Maximum Strength Gas Relief Softgel-60ctSIMETHICONEHEBf65e362a-2f90-428a-b885-eefdad8cae1e2024-12-16WarningsExact identifier
ndc (package): 37808-813-06
ndc (product): 37808-813
ndc11 (package): 37808081306
spl id: 35e27c03-8b87-4436-abef-6ff4b21ee1fe
spl set id: f65e362a-2f90-428a-b885-eefdad8cae1e

Reported adverse events (FAERS/openFDA)#

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