FDA.reportPublic FDA data

Gas Relief

Manufacturer
NORTHEAST PHARMA (Heartland Pharma)
Effective date
2024-04-11
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:06:00

Label at a glance#

ProductGas Relief Ultra Strength
Active ingredientDIMETHICONE
Label structure10 sections

Dosage and administration

swallow one or two softgels as symptoms occur do not exceed two softgels per 24 hours except under the advice and supervision of a physician

Storage and handling

store between 15-30ºC (59-86ºF) protect from heat and moisture

Label contents#

Full prescribing information#

Active ingredient (in each softgel)

OTC - ACTIVE INGREDIENT SECTION

Simethicone 180 mg

Purpose

OTC - PURPOSE SECTION

Antigas

Use

INDICATIONS & USAGE SECTION

  • relieves bloating, pressure, or fullness commonly referred to as gas

Warnings

WARNINGS SECTION

Stop use and ask a doctor if

OTC - STOP USE SECTION

condition persists.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health care professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

  • swallow one or two softgels as symptoms occur
  • do not exceed two softgels per 24 hours except under the advice and supervision of a physician

Other information

STORAGE AND HANDLING SECTION

  • store between 15-30ºC (59-86ºF)
  • protect from heat and moisture

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD&C red #40*,FD&C yellow # 6, gelatin, glycerin

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-800-383-0648

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to active ingredient in PHAZYME® ULTRA STRENGTH†

Ultra Strength

GAS RELIEF

Simethicone, 180 mg | Antigas

Fast relief of:

  • Gas
  • Pressure
  • Bloating
  • Discomfort

Softgels

**This product is not manufactured or distributed by C.B. Fleet Company Inc., distributor of Phazyme® Ultra Strength.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Distributed by: NORTHEAST PHARMA

South Burlington, VT 05403

www.heartlandpharmaco.com

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HEARTLAND PHARMA Ultra Strength Gas Relief
HEARTLAND PHARMA Ultra Strength Gas Relief

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80136-792GAS RELIEF ULTRA STRENGTH (SIMETHICONE) CAPSULE, LIQUID FILLED [NORTHEAST PHARMA (HEARTLAND PHARMA)]3Legacy NDC20240413_6834d4e5-df95-424c-9724-1f4efc748cf0.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80136-79280136-792-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIMETHICONE92RU3N3Y1OACTIB
FD&C YELLOW NO. 6H77VEI93A8IACT
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
FD&C RED NO. 40WZB9127XOAIACT

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
6eb57536-3e23-454c-90b7-2b721934c7b26834d4e5-df95-424c-9724-1f4efc748cf02024-04-11WarningsExact identifier
spl id: 6eb57536-3e23-454c-90b7-2b721934c7b2
spl set id: 6834d4e5-df95-424c-9724-1f4efc748cf0

Reported adverse events (FAERS/openFDA)#

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