FDA.reportPublic FDA data

Simethicone Capsules USP, 125 mg

Manufacturer
Dr. Reddy's Laboratories Inc.
Effective date
2025-12-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:29:25

Label at a glance#

ProductGas Relief
Active ingredientDIMETHICONE
Label structure11 sections

Dosage and administration

adults and children 12 years and older: swallow with water 1 or 2 softgels as needed after meals and at bedtime do not exceed 4 softgels in 24 hours except under the advice and supervision of a physician

Label contents#

Full prescribing information#

SPL PRODUCT DATA ELEMENTS SECTION

SPL UNCLASSIFIED SECTION

Active ingredient (in each Softgel)

OTC - ACTIVE INGREDIENT SECTION

Simethicone USP, 125 mg

Purpose

OTC - PURPOSE SECTION

Antigas

Use

INDICATIONS & USAGE SECTION

for the relief of

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

Warnings

WARNINGS SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 12 years and older: swallow with water 1 or 2 softgels as needed after meals and at bedtime
  • do not exceed 4 softgels in 24 hours except under the advice and supervision of a physician

Other information

OTHER SAFETY INFORMATION

  • store at controlled room temperature 20-25ºC (68-77ºF)
  • protect from light, heat and moisture

Inactive ingredients

INACTIVE INGREDIENT SECTION

D&C yellow no.10, FD&C blue no. 1, gelatin, glycerin, peppermint oil, purified water, sorbitol sorbitan solution, titanium dioxide

Questions or comments?

SPL UNCLASSIFIED SECTION

call 1-888-375-3784 Weekdays (8 AM to 8 PM EST)

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 75907-365-30

Compare to Extra Strength Gas-X ® active ingredient*

Gas Relief

Simethicone Capsules USP, 125 mg

Antigas

Relieves Gas Fast

Pressure, Bloating, Discomfort

30 Softgels

*This product is not manufactured or distributed by GSK Consumer Healthcare. Haleon CH SARL is the owner of the registered trademark Gas-X®.

Distributed By:

Dr. Reddy's Laboratories, Inc.

Princeton, NJ 08540

REV 12/25

Made in India

Bottle LabelBottle Label

Carton
Carton

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 75907-365-01

Compare to Extra Strength Gas-X ® active ingredient*

Gas Relief

Simethicone Capsules USP, 125 mg

Antigas

Relieves Gas Fast

Pressure, Bloating, Discomfort

150 Softgels

*This product is not manufactured or distributed by GSK Consumer Healthcare. Haleon CH SARL is the owner of the registered trademark Gas-X®.

Distributed By:

Dr. Reddy's Laboratories, Inc.

Princeton, NJ 08540

REV 12/25

Made in India

Bottle label
Bottle label
Carton
Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198852simethicone 125 MG Oral CapsulePSN1
198852simethicone 125 MG Oral CapsuleSCD1
198852dimethicone 125 MG Oral CapsuleSY1

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
75907-365-01Gas Relief1 in 1 CARTONCAPSULE, LIQUID FILLED11
75907-365-01Gas Relief150 in 1 BOTTLECAPSULE, LIQUID FILLED1501
75907-365-30Gas Relief30 in 1 BOTTLECAPSULE, LIQUID FILLED301
75907-365-30Gas Relief1 in 1 CARTONCAPSULE, LIQUID FILLED11

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
75907-36575907-365-30, 75907-365-01

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
D&C YELLOW NO. 1035SW5USQ3GIACT
DIMETHICONE92RU3N3Y1OACTIB
TITANIUM DIOXIDE15FIX9V2JPIACT
GELATIN2G86QN327LIACT
PEPPERMINT OILAV092KU4JHIACT
SORBITOL506T60A25RIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
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
Gas ReliefSIMETHICONE CAPSULES USP, 125 MGDr. Reddy's Laboratories Inc.b3069d83-5654-8469-302a-0f76c30e39762025-12-15WarningsExact identifier
ndc (package): 75907-365-30
ndc (package): 75907-365-01
ndc (product): 75907-365
ndc11 (package): 75907036530
ndc11 (package): 75907036501
spl id: 33ce0317-d90e-aaa5-2ea7-e6b552ed6e5b
spl set id: b3069d83-5654-8469-302a-0f76c30e3976

Reported adverse events (FAERS/openFDA)#

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