Gas Relief

Manufacturer
Major Pharmaceuticals | Humanwell Puracap Pharmaceuticals (Wuhan) Co., Ltd | LNK International, Inc.
Effective date
2019-11-14
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-02 00:01:19

Label at a glance#

ProductGas Relief Extra Strength
Active ingredientDIMETHICONE
Label structure9 sections

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 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF) 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

Use

INDICATIONS & USAGE SECTION

relieves bloating, pressure, fullness, or stuffed feeling 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 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • 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, lecithin, mineral oil, peppermint oil,
purified water, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

(800)-616-2471

Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MAJOR®

NDC 0904-6606-36

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

Extra Strength
  Gas Relief 

Simethicone 125 mg
Antigas

Relieves
Pressure
Bloating
Discomfort

Easy to Swallow

30 Softgels

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

Distributed by MAJOR® PHARMACEUTICALS
17177 N Laurel Park Drive, Suite 233
Livonia, MI 48152 USA
Re-order No. 700831
M-17       Rev. 10/16

*This product is not manufactured or distributed by Novartis Consumer Health, Inc., owner of the registered trademark Gas-X® Extra Strength.

50844    ORG121566401

Product of China
Packaged and Quality Assured in the USA

Major 44-664
Major 44-664

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6606-36EA - Each0904-6606209a732e-9c2d-4da9-990b-4c9f48c898c412017-03-06

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0904-66060904-6606-36

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

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
c88c3ab7-796e-4855-9d49-847197fd69ab6b449c40-5d41-477a-8127-fa13cf1100862019-11-14WarningsExact identifier
spl id: c88c3ab7-796e-4855-9d49-847197fd69ab
spl set id: 6b449c40-5d41-477a-8127-fa13cf110086

Reported adverse events (FAERS/openFDA)#

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