Helium

Helium

Drug Labeling and Warnings

Drug Details

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HELIUM- helium gas 
Roberts Oxygen Company, Inc.

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Helium

HELIUM,
COMPRESSED
USP
UN1046
NON-FLAMMABLE GAS 2
Rx ONLY. WARNING: Administration of Helium USP 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 USP and is familiar with the indications, effects, dosages, methods, and frequency and duration of administration, and the hazards, contraindications and side effects and the precautions to be taken. 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 preventative 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 52ºC (125ºF). 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.
CAS: 7440-59-7  DO NOT REMOVE THIS PRODUCT LABEL.
Roberts Oxygen Company, Inc.
PO BOX 5507 Rockville, MD 20855
301-948-8100

image of cylinder label

HELIUM 
helium gas
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 46123-008
Route of AdministrationRESPIRATORY (INHALATION)
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Helium (UNII: 206GF3GB41) (Helium - UNII:206GF3GB41) Helium990 mL  in 1 L
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 46123-008-01102 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1967
2NDC: 46123-008-02374 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1967
3NDC: 46123-008-03623 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1967
4NDC: 46123-008-043880 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1967
5NDC: 46123-008-055436 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1967
6NDC: 46123-008-066910 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1967
7NDC: 46123-008-078241 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/1967
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA20586401/01/1967
Labeler - Roberts Oxygen Company, Inc. (042646877)

Revised: 12/2016
 
Roberts Oxygen Company, Inc.


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