Helium by Airgas Intermountain Inc HELIUM gas

Helium by

Drug Labeling and Warnings

Helium by is a Prescription medication manufactured, distributed, or labeled by Airgas Intermountain Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PRINCIPAL DISPLAY PANEL

HELIUM, COMPRESSED USP
UN1046
NON-FLAMMABLE 2
30580 (05/02)

Rx only. CAUTION: Federal law prohibits dispensing without a prescription. 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, effects, dosages, methods, and frequency and duration of administration, and with the hazards, contraindications and side effects, and the precautions to be taken.

CAUTION: HIGH PRESSURE GAS. CAN CAUSE RAPID SUFFOCATION. Store and use with adequate ventilation. Use equipment rated for cylinder pressure. Cylinder temperature should not exceed 52oC(125oF). Close valve after each use and when empty. Use in accordance with the Material Safety Data Sheet (MSDS). Inhaling Helium to alter the voice may prove fatal and should not be permitted. FIRST AID:   IF INHALED, remove to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen. Call a physician.     C.A.S. : 7440-59-7        DO NOT REMOVE THIS PRODUCT LABEL.
AIRGAS PURITAN MEDICAL Distributed By: Airgas Intermountain, Inc. Denver, CO 80216 (303) 370-7800

INGREDIENTS AND APPEARANCE

HELIUM 
helium gas

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 58420-004
Route of Administration	RESPIRATORY (INHALATION)

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Helium (UNII: 206GF3GB41) (Helium - UNII:206GF3GB41)	Helium	992 mL  in 1 L

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58420-004-01	113 L in 1 CYLINDER
2	NDC: 58420-004-02	170 L in 1 CYLINDER
3	NDC: 58420-004-03	227 L in 1 CYLINDER
4	NDC: 58420-004-04	368 L in 1 CYLINDER
5	NDC: 58420-004-05	510 L in 1 CYLINDER
6	NDC: 58420-004-06	595 L in 1 CYLINDER
7	NDC: 58420-004-07	1019 L in 1 CYLINDER
8	NDC: 58420-004-08	2095 L in 1 CYLINDER
9	NDC: 58420-004-09	3115 L in 1 CYLINDER
10	NDC: 58420-004-10	5493 L in 1 CYLINDER
11	NDC: 58420-004-11	8212 L in 1 CYLINDER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved medical gas		01/01/1985

Labeler - Airgas Intermountain Inc (019714331)

Establishment
Name	Address	ID/FEI	Business Operations
Airgas Intermountain Inc		072198059	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Airgas Intermountain Inc		084208433	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Airgas Intermountain Inc		943069948	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Airgas Intermountain Inc		883003915	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Airgas Intermountain Inc		090327250	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Airgas Intermountain Inc		182466243	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Airgas Intermountain Inc		054313408	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Airgas Intermountain Inc		618581441	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Airgas Intermountain Inc		859665069	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Airgas Intermountain Inc		128647740	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Airgas Intermountain Inc		020467911	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Airgas Intermountain Inc		126606222	manufacture

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Airgas Intermountain Inc		847756426	manufacture

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Airgas Intermountain Inc		165006818	manufacture

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Airgas Intermountain Inc		149496028	manufacture

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Airgas Intermountain Inc		806310637	manufacture

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Name	Address	ID/FEI	Business Operations
Airgas Intermountain Inc		946412723	manufacture

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Airgas Intermountain Inc		082728627	manufacture

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Airgas Intermountain Inc		791450422	manufacture

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Airgas Intermountain Inc		097765218	manufacture

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Airgas Intermountain Inc		190164744	manufacture

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Airgas Intermountain Inc		789145745	manufacture

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Airgas Intermountain Inc		611965146	manufacture

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Airgas Intermountain Inc		793984089	manufacture

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Airgas Intermountain Inc		790441885	manufacture

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Name	Address	ID/FEI	Business Operations
Airgas Intermountain Inc		028348386	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Airgas Intermountain Inc		931891407	manufacture