FDA.reportPublic FDA data

gas relief

Manufacturer
Strategic Sourcing Services, LLC (Sunmark) | LNK International, Inc.
Effective date
2023-05-09
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
legacy-cache
Hydrated at
2026-08-01 21:31:35

Label at a glance#

Productgas relief Extra Strength
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: swallow with water 1 or 2 capsules as needed after meals and at bedtime do not exceed 4 capsules in 24 hours unless directed by a doctor

Storage and handling

TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) protect from light, heat and moisture see end flap for expiration date and lot number

Label contents#

Full prescribing information#

Active ingredient (in each liquid-filled capsule)

OTC - ACTIVE INGREDIENT SECTION

Simethicone 125 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

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults: swallow with water 1 or 2 capsules as needed after meals and at bedtime
  • do not exceed 4 capsules in 24 hours unless directed by a doctor

Other information

STORAGE AND HANDLING SECTION

  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • protect from light, heat and moisture
  • see end flap for expiration date and lot number

Inactive ingredients

INACTIVE INGREDIENT SECTION

D&C yellow #10, edible white ink, FD&C blue #1, FD&C red #40, gelatin, glycerin, peppermint oil, purified water, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

1-800-426-9391

Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

sunmark®

COMPARE TO
GAS-X® EXTRA STRENGTH
ACTIVE INGREDIENT*

NDC 49348-073-09

Extra Strength
gas relief
SIMETHICONE 125 mg
Antigas

relieves
pressure
bloating
discomfort

actual
size

EASY TO SWALLOW

50 SOFTGELS

TAMPER EVIDENT: DO NOT USE IF
PACKAGE IS OPENED OR IF BLISTER
UNIT IS TORN, BROKEN OR SHOWS
ANY SIGNS OF TAMPERING

*This product is not manufactured or distributed by GSK Consumer Healthcare S.A.,
owner of the registered trademark Gas-X® Extra Strength.
50844              REV0419A66415

Product of China
Packaged and Quality Assured in the USA

MCKESSON
Distributed by McKesson Corporation
6555 State Highway 161
Irving, TX 75039
www.mckesson.com

SunMark 44-664SunMark 44-664

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49348-073-09EA - Each49348-073822db29a-417e-41e5-b356-24d47cf9700412016-07-19

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
49348-07349348-073-09

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
DIMETHICONE92RU3N3Y1OACTIB
D&C YELLOW NO. 1035SW5USQ3GIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C RED NO. 40WZB9127XOAIACT
GELATIN, UNSPECIFIED2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
PEPPERMINT OILAV092KU4JHIACT
WATER059QF0KO0RIACT
TITANIUM DIOXIDE15FIX9V2JPIACT

Source Document#

Source XML · Source PDF

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
3cd3b8ed-e6b6-4e58-b5c7-845d61d3118a66e393f3-55bf-4855-9fd3-ca647cafb3c22023-06-20WarningsExact identifier
spl set id: 66e393f3-55bf-4855-9fd3-ca647cafb3c2

Reported adverse events (FAERS/openFDA)#

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