Helium by NexAir, LLC / NEXAIR, LLC HELIUM gas

Helium by

Drug Labeling and Warnings

Helium by is a Prescription medication manufactured, distributed, or labeled by NexAir, LLC, NEXAIR, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PRINCIPAL DISPLAY PANEL

HELIUM, COMPRESSED USP UN1046 NON-FLAMMABLE GAS 2
WARNING: CONTAINS GAS UNDER PRESSURE; MAY EXPLODE IF HEATED. MAY DISPLACE OXYGEN AND CAUSE RAPID SUFFOCATION. Do not handle until all safety precautions have been read and understood. Use and store only outdoors or in a well-ventilated place. Use a back flow preventive device in the piping. Use only with equipment rated for cylinder pressure. 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 INHALED: Remove person to fresh air and keep comfortable for breathing. Get medical advice/attention. Rx only. Administration of Helium 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 Helium 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.
CAS 7440-59-7
DO NOT REMOVE THIS PRODUCT LABEL
Net Contents Cubic Feet: Liters:
nexAir
Distributed by nexAir, LLC . www.nexAir.com
1385 Corporate Ave. . Memphis, TN 38132 . 888-639-2474
LOT #: PART #: CF. LITERS:

INGREDIENTS AND APPEARANCE

HELIUM 
helium gas

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 12213-710
Route of Administration	RESPIRATORY (INHALATION)

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HELIUM (UNII: 206GF3GB41) (HELIUM - UNII:206GF3GB41)	HELIUM	999 mL  in 1 L

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 12213-710-60	113 L in 1 CYLINDER; Type 0: Not a Combination Product	06/01/1996
2	NDC: 12213-710-13	408 L in 1 CYLINDER; Type 0: Not a Combination Product	06/01/1996
3	NDC: 12213-710-40	425 L in 1 CYLINDER; Type 0: Not a Combination Product	06/01/1996
4	NDC: 12213-710-58	586 L in 1 CYLINDER; Type 0: Not a Combination Product	06/01/1996
5	NDC: 12213-710-50	2067 L in 1 CYLINDER; Type 0: Not a Combination Product	06/01/1996
6	NDC: 12213-710-12	6145 L in 1 CYLINDER; Type 0: Not a Combination Product	06/01/1996

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA205851	06/01/1996

Labeler - NexAir, LLC (927024422)

Establishment
Name	Address	ID/FEI	Business Operations
NexAir, LLC		078438899	manufacture(12213-710)

Establishment
Name	Address	ID/FEI	Business Operations
NexAir, LLC		603601050	manufacture(12213-710)

Establishment
Name	Address	ID/FEI	Business Operations
NexAir, LLC		927024422	manufacture(12213-710)