Heliox by Spec Connection International Inc / Spec Connection International, Inc. HELIOX gas

Heliox by

Drug Labeling and Warnings

Heliox by is a Prescription medication manufactured, distributed, or labeled by Spec Connection International Inc, Spec Connection International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

HELIOX 
heliox gas

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 54776-001
Route of Administration	RESPIRATORY (INHALATION)

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Oxygen (UNII: S88TT14065) (Oxygen - UNII:S88TT14065)	Oxygen	300 mL  in 1 L
Helium (UNII: 206GF3GB41) (Helium - UNII:206GF3GB41)	Helium	700 mL  in 1 L

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54776-001-01	707 L in 1 CYLINDER
2	NDC: 54776-001-02	5663 L in 1 CYLINDER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved medical gas		01/01/2013

Labeler - Spec Connection International Inc (059854468)

Establishment
Name	Address	ID/FEI	Business Operations
Spec Connection International, Inc.		026151816	manufacture(54776-001)