Heliox

Manufacturer
Spec Connection International Inc | Spec Connection International, Inc.
Effective date
2012-12-19
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 20:16:23

Label at a glance#

ProductHeliox
Active ingredientOxygen, Helium
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

OXYGEN 2 NON-FLAMMABLE GAS 2 Compressed Gas, oxidizing, n.o.s. (Oxygen, Helium) UN3156 Medical Gas Mixture 25% Oxygen, USP CAS: 7782-44-7 Balance Helium, USP CAS: 7740-59-7 CAUTION: Federal law prohibits dispensing without a prescription. Rx Only. WARNING: OXIDIZING HIGH PRESSURE GAS. VIGOROUSLY ACCELERATES COMBUSTION. Keep oil and grease away. Use only with equipment cleaned for oxygen service and rated for cylinder pressure. Use equipment rated for cylinde pressure. Store and use with adequate ventilation. Close valve after each use and when empty. Open valve slowly. Administration of this gas mixture may be hazardous or contraindicated. For use only by or under the supervision of a licensed practitioner who is experienced in the use and administration of gas mixtures and is familiar with the indications, effects, dosages, methods, and frequency and duration of administration, and with the hazards, contraindications and side effects and the precautions to be taken. Use in accordance with the appropriate MSDS for each mixture component. Secure cylinder while in transportation, storage, and in use. Serial Number: 283751 In Emergency Call: 1-800-494-9300 Lot No: 338sci12dp1 Volume 25 Exp Date: 12/11/17 Label #: RG101 December 12, 2012 Ver 2.33 For Medical Use Only. Spec Connection International Inc 37325 sr 54 Zephyrhills, FL 33542 Ph# 813-997-8950
heliox one
heliox one

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
347048helium 70 % / oxygen 30 % Gas for InhalationPSN1
347048helium 70 % / oxygen 30 % Gas for InhalationSCD1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54776-001-012019-11-27C16284748780-19855d018-dfcd-cd31-e053-dbdaa90ab51aHeliox
54776-001-022019-11-27C16284748780-19855d018-dfcd-cd31-e053-dbdaa90ab51aHeliox

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54776-001-01Heliox707 L in 1 CYLINDERGAS7071
54776-001-02Heliox5663 L in 1 CYLINDERGAS56631

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54776-001HELIOX GAS [SPEC CONNECTION INTERNATIONAL INC]1Legacy NDC, 2 package rows20130101_bc4ebe9a-da94-4be8-a6d3-25e8a365d20d.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
HeliumACTIVE INGREDIENT206GF3GB411
OxygenACTIVE INGREDIENTS88TT140651
HeliumACTIVE MOIETY206GF3GB411
OxygenACTIVE MOIETYS88TT140651

Products#

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

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54776-00154776-001-01, 54776-001-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
OxygenS88TT14065ACTIB
Helium206GF3GB41ACTIB

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
a034ea4d-bf91-4300-87ed-0f685c7cea53bc4ebe9a-da94-4be8-a6d3-25e8a365d20d2012-12-19Exact identifier
spl id: a034ea4d-bf91-4300-87ed-0f685c7cea53
spl set id: bc4ebe9a-da94-4be8-a6d3-25e8a365d20d

Reported adverse events (FAERS/openFDA)#

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