FDA.reportPublic FDA data

gas relief

Manufacturer
SUPERVALU INC. | LNK International, Inc.
Effective date
2022-10-21
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:51:05

Label at a glance#

Productgas relief
Active ingredientDIMETHICONE
Label structure9 sections

Indications and uses

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

Dosage and administration

do not take more than directed chew or crush tablets completely before swallowing; do not swallow tablets whole adults and children 12 years and over: take 1 or 2 chewable tablets as needed after meals and at bedtime do not exceed 4 chewable tablets in 24 hours unless directed by a doctor children under 12 years: ask a doctor

Storage and handling

each tablet contains: calcium 85 mg 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 moisture see end flap for expiration date and lot number

Label contents#

Full prescribing information#

Active ingredient (in each chewable tablet)

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

  • do not take more than directed
  • chew or crush tablets completely before swallowing; do not swallow tablets whole
  • adults and children 12 years and over: take 1 or 2 chewable tablets as needed after meals and at bedtime
  • do not exceed 4 chewable tablets in 24 hours unless directed by a doctor
  • children under 12 years: ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • each tablet contains: calcium 85 mg
  • 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 moisture
  • see end flap for expiration date and lot number

Inactive ingredients

INACTIVE INGREDIENT SECTION

corn starch, crospovidone, D&C yellow #10 aluminum lake, dextrates hydrated, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, silicon dioxide, sucralose, triacetin, tribasic calcium phosphate

Questions or comments?

OTC - QUESTIONS SECTION

1-855-423-2630

Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 41163-935-44

Compare to Gas-X®
Extra Strength
active ingredient*

extra strength
gas relief

simethicone 125 mg
chewable tablets
(anti-gas)

peppermint
creme flavor

relieves:
• bloating
• pressure 
• discomfort

CHEW OR CRUSH TABLETS COMPLETELY BEFORE SWALLOWING.
DO NOT SWALLOW TABLETS WHOLE.

actual size

18 chewable tablets

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      REV1220A63544

DISTRIBUTED BY UNFI
PROVIDENCE, RI 02908 USA

Equaline 44-635Equaline 44-635

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
41163-93541163-935-44

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIMETHICONE92RU3N3Y1OACTIB
STARCH, CORNO8232NY3SJIACT
CROSPOVIDONE2S7830E561IACT
D&C YELLOW NO. 10 ALUMINUM LAKECQ3XH3DET6IACT
DEXTROSE MONOHYDRATELX22YL083GIACT
MAGNESIUM STEARATE70097M6I30IACT
MALTODEXTRIN7CVR7L4A2DIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SUCRALOSE96K6UQ3ZD4IACT
TRIACETINXHX3C3X673IACT
TRIBASIC CALCIUM PHOSPHATE91D9GV0Z28IACT
DIMETHICONE 410TYU5GP6XGEIACT

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
c0d6abd5-81ed-467d-9da7-51700679730b3280e1bb-d6e0-466c-910e-80b05253c2042022-10-21WarningsExact identifier
spl id: c0d6abd5-81ed-467d-9da7-51700679730b
spl set id: 3280e1bb-d6e0-466c-910e-80b05253c204

Reported adverse events (FAERS/openFDA)#

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