FDA.reportPublic FDA data

Heartland Pharma 44-608

Manufacturer
Heartland Pharma Co. | LNK International, Inc.
Effective date
2026-10-01
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
daily-update
Hydrated at
2026-10-06 02:02:40

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 store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) protect from moisture use by expiration date on package

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
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • protect from moisture
  • use by expiration date on package

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

1-800-383-0648

Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Heartland®
Pharma Co.

NDC 80136-859-68

Extra Strength
GAS RELIEF
Simethicone 125 mg Chewable Tablets
Antigas

Relieves
✔ Pressure
✔ Bloating
✔ Discomfort

Chew or crush tablets
completely before
swallowing.

Cherry Flavor

Actual Size

Compare to the
active ingredient in
Gas-X® Extra Strength*

Do not swallow tablets whole.

100 Chewable Tablets

44-608
44-608

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
Data codeCode 128X003YW9JYPheartland-pharma-44-608-1.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

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
80136-85980136-859-68

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
CROSPOVIDONE, UNSPECIFIED2S7830E561IACT
D&C RED NO. 27 ALUMINUM LAKEZK64F7XSTXIACT
D&C RED NO. 30 ALUMINUM LAKEGE75M6YV5WIACT
DEXTROSE MONOHYDRATELX22YL083GIACT
FD&C RED NO. 40 ALUMINUM LAKE6T47AS764TIACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
STARCH, CORNO8232NY3SJIACT
SUCRALOSE96K6UQ3ZD4IACT
TRIBASIC CALCIUM PHOSPHATE91D9GV0Z28IACT
DIMETHICONE 410TYU5GP6XGEIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
72025-10-03full-release2026-06-01 01:15:43

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 ReliefSIMETHICONEHeartland Pharma Co.0860114c-53ec-48bd-a2f2-0b0bf8d2db6e2025-10-03WarningsExact identifier
ndc (package): 80136-859-68
ndc (product): 80136-859
ndc11 (package): 80136085968
spl set id: 0860114c-53ec-48bd-a2f2-0b0bf8d2db6e

Reported adverse events (FAERS/openFDA)#

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