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

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

INGREDIENTS AND APPEARANCE

HELIOX 
heliox gas

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 54776-006
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

Inactive Ingredients
Ingredient Name	Strength
HELIUM (UNII: 206GF3GB41)	700 mL  in 1 L

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54776-006-01	707 L in 1 CYLINDER; Type 0: Not a Combination Product	01/01/2013
2	NDC: 54776-006-02	5663 L in 1 CYLINDER; Type 0: Not a Combination Product	01/01/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA205889	01/01/2013

Labeler - Spec Connection International Inc (059854468)

Establishment
Name	Address	ID/FEI	Business Operations
Spec Connection International, Inc.		026151816	manufacture(54776-006)