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Name:Helium
Manufacturer:Encompass Medical & Specialty Gases, Ltd.
Category:Prescription Marketed Drugs


Helium Label

HELIUM  - helium gas 
Encompass Medical & Specialty Gases, Ltd.

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Helium Label

HELIUM COMPRESSED, USP UN1046
NON-FLAMMABLE GAS  2    37580 (R 06/05)
Rx only. WARNING: Administration of Helium may be hazardous or contraindicated. For use only by or under 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. Use a back flow preventive device in the piping. Cylinder temperatures should not exceed 52C (125F). 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.  CAS: 7440-59-7
DO NOT REMOVE THIS PRODUCT LABEL.
Cylinders must be refilled by:
Encompass Medical and Specialty Gases, LTD. 4646 Linden Road P.O. Box 5404 Rockford, IL 61109
CONTENTS:  LTRS    CU. FT.Helium Label 1


HELIUM 
helium gas
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:48883-006
Route of Administration RESPIRATORY (INHALATION) DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Helium (Helium) Helium 990 mL  in 1 L
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:48883-006-01 91 L in 1 CYLINDER None
2 NDC:48883-006-02 144 L in 1 CYLINDER None
3 NDC:48883-006-03 377 L in 1 CYLINDER None
4 NDC:48883-006-04 624 L in 1 CYLINDER None
5 NDC:48883-006-05 3101 L in 1 CYLINDER None
6 NDC:48883-006-06 6201 L in 1 CYLINDER None
7 NDC:48883-006-07 8143 L in 1 CYLINDER None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved medical gas 04/15/2009

Labeler - Encompass Medical & Specialty Gases, Ltd. (963344143)
Establishment
Name Address ID/FEI Operations
Encompass Medical & Specialty Gases, Ltd. 963344143 manufacture
Establishment
Name Address ID/FEI Operations
Encompass Medical & Specialty Gases, Ltd. 963719286 manufacture
Establishment
Name Address ID/FEI Operations
Encompass Medical & Specialty Gases, Ltd. 963719096 manufacture
Establishment
Name Address ID/FEI Operations
Encompass Medical & Specialty Gases, Ltd. 963718361 manufacture

Revised: 12/2010 Encompass Medical & Specialty Gases, Ltd.



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


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