FDA.reportPublic FDA data

Equaline 44-608

Manufacturer
United Natural Foods, Inc. dba UNFI | LNK International, Inc.
Effective date
2026-05-15
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
full-release
Hydrated at
2026-06-01 01:58:02

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

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

1-855-423-2630

Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 41163-408-44

Compare to
Gas-X®
Extra Strength
active ingredient*

EQUALINE®

extra strength

gas relief
simethicone 125 mg
chewable tablets
(anti-gas)

cherry 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     REV1220C60844

DISTRIBUTED BY UNFI
PROVIDENCE, RI 02908 USA

Like it or let us
make it right.
That’s our
quality promise.
855-423-2630

Equaline 44-608Equaline 44-608

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
314221simethicone 125 MG Chewable TabletPSN10
314221simethicone 125 MG Chewable TabletSCD10

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIMETHICONE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130041163466906GTIN-13: 0041163466906
EAN-13: 0041163466906
GTIN-12: 041163466906
UPC-A: 041163466906
GTIN storage (14 digits): 00041163466906		equaline-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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41163-408-44gas relief9 in 1 BLISTER PACKTABLET, CHEWABLE910
41163-408-44gas relief2 in 1 CARTONTABLET, CHEWABLE210

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
41163-40841163-408-44

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
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

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 reliefSIMETHICONEUnited Natural Foods, Inc. dba UNFI2a82a06d-7511-4fc0-b182-9c1774b2af482026-05-15WarningsExact identifier
ndc (package): 41163-408-44
ndc (product): 41163-408
ndc11 (package): 41163040844
spl id: f1a78b4b-a046-4e27-97e4-38390e99bc3d
spl set id: 2a82a06d-7511-4fc0-b182-9c1774b2af48

Reported adverse events (FAERS/openFDA)#

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