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Name:Helium
Manufacturer:Specialty Gases Of America, Inc
Category:Prescription Marketed Drugs


HELIUM  - helium gas 
Specialty Gases of America, Inc

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HELIUM COMPRESSED LABEL

HELIUM, COMPRESSED, USP NON-FLAMMABLE GAS - 2 UN 1046


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, EFFECTS, DOSAGES, METHODS, AND FREQUENCY AND DURATION OF ADMINISTRATION, AND WITH THE HAZARDS, CONTRAINDICATIONS, AND SIDE EFFECTS AND THE PRECAUTIONS TO BE TAKEN. 

AGG 27 (05/08)

HELIUM SHOULDER LABEL

GENERAL WARNINGS AND PRECAUTIONS

CAUTION: HIGH PRESSURE GAS CAN CAUSE RAPID SUFFOCATION.  STORE AND USE WITH ADEQUATE VENTILATION.  USE EQUIPMENT RATED FOR CYLINDER PRESSURE.  USE A BACK FLOW PREVENTATIVE DEVICE IN THE PIPING.  CYLINDER TEMPERATURE SHOULD NOT EXCEED 52 C (125 F).  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.  CAL A PHYSICIAN.  DO NOT REMOVE THIS PIPING.  CAS 7440-59-7


HELIUM 
helium gas
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68693-018
Route of Administration RESPIRATORY (INHALATION) DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HELIUM (HELIUM) HELIUM 99 L  in 100 L
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68693-018-01 103 L in 1 CYLINDER None
2 NDC:68693-018-02 150 L in 1 CYLINDER None
3 NDC:68693-018-03 255 L in 1 CYLINDER None
4 NDC:68693-018-04 671 L in 1 CYLINDER None
5 NDC:68693-018-05 3462 L in 1 CYLINDER None
6 NDC:68693-018-06 255 L in 1 CYLINDER None
7 NDC:68693-018-07 6482 L in 1 CYLINDER None
8 NDC:68693-018-08 7415 L in 1 CYLINDER None
9 NDC:68693-018-09 8100 L in 1 CYLINDER None
10 NDC:68693-018-10 145800 L in 1 CYLINDER None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved medical gas 01/01/1995

Labeler - Specialty Gases of America, Inc (073446739)
Registrant - Specialty Gases of America, Inc (073446739)
Establishment
Name Address ID/FEI Operations
Specialty Gases of America, Inc 036719938 manufacture

Revised: 10/2010 Specialty Gases of America, Inc



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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