Heliox

Manufacturer
Spec Connection International Inc | Spec Connection International, Inc.
Effective date
2024-11-19
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-05-31 21:17:40

Label at a glance#

ProductHeliox
Active ingredientOXYGEN
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NON-FLAMMABLE 2 OXYGEN 2 Compressed gas, oxidizing, n.o.s. (Oxygen, Helium) UN3156 Medical Gas Mixture 25% Oxygen, USP CAS: 7782-44-7 Balance Helium, USP CAS: 7440-59-7 Rx only WARNING: 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. DANGER: CONTAINS GAS UNDER PRESSURE; MAY EXPLODE IF HEATED MAY CAUSE OR INTENSIFY FIRE; OXIDIZER.
Do not handle until all safety precautions have been read and understood. Keep and store away from clothing and other combustible materials. Keep valves and fittings free from grease and oil. Use and store only outdoors or in a well-ventilated place. Use a back flow preventive device in the piping. Use only with equipment of compatible materials of construction and rated for cylinder pressure. Use only with equipment cleaned for oxygen service. Open valve slowly. Close valve after each use and when empty. Protect from sunlight when ambient temperature exceeds 52 degrees C (125 degrees F). Read and follow the Safety Data Sheet (SDS) before use.
FIRST AID: IF ACCIDENTALLY INHALED: Remove person to fresh air and keep comfortable for breathing. Get medical advice/attention.
DO NOT REMOVE THIS PRODUCT LABEL. For Medical Use Only.
SPEC CONNECTION INTERNALTIONAL, INC. 37325 STATE ROAD 54. ZEPHYRHILLS, FL 33542 813-997-7646 helioxheliox

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54776-006HELIOX GAS [SPEC CONNECTION INTERNATIONAL INC]8Legacy NDC20241121_614182b5-5aa5-9efd-e053-2991aa0a7578.zip

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
54776-00654776-006-01, 54776-006-02

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
HELIUM206GF3GB41IACT

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

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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
42660879-e196-bc39-e063-6394a90a8146614182b5-5aa5-9efd-e053-2991aa0a75782025-10-30Exact identifier
spl set id: 614182b5-5aa5-9efd-e053-2991aa0a7578

Reported adverse events (FAERS/openFDA)#

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