FDA.reportPublic FDA data

Gas Relief

Manufacturer
L.N.K. International, Inc. | LNK International, Inc.
Effective date
2021-03-22
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 22:48:38

Label at a glance#

ProductGas Relief
Active ingredientDIMETHICONE
Label structure11 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 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF) 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 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • protect from moisture
  • see end flap for expiration date and lot number

Inactive ingredients

INACTIVE INGREDIENT SECTION

crospovidone, D&C red #27 aluminum lake, D&C red #30 aluminum lake, dextrates hydrated, FD&C red #40 aluminum lake, flavor, magnesium stearate, microcrystalline cellulose, silicon dioxide, starch, sucralose, tribasic calcium phosphate

Questions or comments?

OTC - QUESTIONS SECTION

1-800-426-9391

Principal Display Panel - Rite Aid

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Rite Aid 44-608Rite Aid 44-608

Principal Display Panel - Exchange Select

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Exchange select 44-608
Exchange select 44-608

Principal Display Panel - Equaline

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Equaline 44-608
Equaline 44-608

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50844-97250844-972-44, 50844-972-22

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIMETHICONE92RU3N3Y1OACTIB
CROSPOVIDONE2S7830E561IACT
D&C RED NO. 27 ALUMINUM LAKEZK64F7XSTXIACT
D&C RED NO. 302S42T2808BIACT
DEXTROSE MONOHYDRATELX22YL083GIACT
FD&C RED NO. 40WZB9127XOAIACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
STARCH, CORNO8232NY3SJIACT
SUCRALOSE96K6UQ3ZD4IACT
TRIBASIC CALCIUM PHOSPHATE91D9GV0Z28IACT

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
d4aca6fd-2602-44cf-bb46-c2af5d87e01a3b9c8577-86a6-4acd-80c4-476cc49fa0302021-03-22WarningsExact identifier
spl id: d4aca6fd-2602-44cf-bb46-c2af5d87e01a
spl set id: 3b9c8577-86a6-4acd-80c4-476cc49fa030

Reported adverse events (FAERS/openFDA)#

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