Helium by Linde Gas & Equipment Inc. HELIUM- helium gas

Helium by

Drug Labeling and Warnings

Helium by is a Prescription medication manufactured, distributed, or labeled by Linde Gas & Equipment Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

WARNINGS SECTION

WARNING: 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, effect, dosages, methods and frequency and duration of administration, and the hazards, methods and frequency and duration of administration, and the hazards, contraindication and side effects and the precautions to be taken.

Linde

HELIUM, COMPRESSED USP

UN1046
CAS 7440-59-7

Distributed by:
Linde Gas North America LLC
200 Somerset Corporate Blvd., Suite 7000
Bridgewater, NJ 08807
866.543.3427

MEDICAL GAS

Rx only

WARNING: 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, effect, dosages, methods and frequency and duration of administration, and the hazards, methods and frequency and duration of administration, and the hazards, contraindication and side effects and the precautions to be taken.

WARNING: CONTAINS GAS UNDER PRESSURE; MAY EXPLODE IF HEATED. MAY DISPACE 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°C (125°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.

DO NOT REMOVE THIS LABEL.

CONTENTS:

Cylinder Type	Liters
K	5888	[_]
M	2830	[_]
M4	96	[_]
D	374	[_]
E	577	[_]
______	______	______

MG150B

HELIUM, COMPRESSED

USP

UN1046
CAS 7440-59-7
DO NOT REMOVE THIS PRODUCT LABEL.

2

MEDICAL GAS

Rx only

Linde

WARNING: 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, effect, dosages, methods and frequency and duration of administration, and the hazards, methods and frequency and duration of administration, and the hazards, contraindication and side effects and the precautions to be taken.

CAUTION: CONTAINS GAS UNDER PRESSURE; MAY EXPLODE IF HEATED. MAY DISPACE 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°C (125°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.

CONTENTS:

Cylinder; Type	Liters
K	5688	[_]
M	2830	[_]
_______	_______	_______

Distributed by:
Linde Gas North America LLC
200 Somerset Corporate Blvd., Suite 7000
Bridgewater, NJ 08807
866.543.3427

MG006G

INGREDIENTS AND APPEARANCE

HELIUM  
helium gas

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 25373-010
Route of Administration	RESPIRATORY (INHALATION)

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Helium (UNII: 206GF3GB41) (Helium - UNII:206GF3GB41)	Helium	99 L  in 100 L

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 25373-010-04	5688 L in 1 CYLINDER; Type 0: Not a Combination Product	11/27/1990
2	NDC: 25373-010-05	2830 L in 1 CYLINDER; Type 0: Not a Combination Product	11/27/1990
3	NDC: 25373-010-06	5888 L in 1 CYLINDER; Type 0: Not a Combination Product	11/27/1990
4	NDC: 25373-010-07	96 L in 1 CYLINDER; Type 0: Not a Combination Product	11/27/1990
5	NDC: 25373-010-08	374 L in 1 CYLINDER; Type 0: Not a Combination Product	11/27/1990
6	NDC: 25373-010-09	577 L in 1 CYLINDER; Type 0: Not a Combination Product	11/27/1990

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA206826	11/27/1990

Labeler - Linde Gas North America LLC (805568339)

Registrant - Linde Gas North America LLC (805568339)

Establishment
Name	Address	ID/FEI	Business Operations
Linde Gas North America LLC		010263301	MANUFACTURE(25373-010)

Establishment
Name	Address	ID/FEI	Business Operations
Linde Gas North America LLC		016271697	MANUFACTURE(25373-010)