Helium by GT Industries Inc HELIUM gas

Helium by

Drug Labeling and Warnings

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

Drug Details [pdf]

PRINCIPAL DISPLAY PANEL

HELIUM, COMPRESSED U.S.P.
NON-FLAMMABLE GAS 2           
WARNING: SECURE ALL CYLINDERS WHILE IN STORAGE AND IN USE. CAUTION: FEDERAL LAW PROHIBITS DISPENSING WITHOUT 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. Use in accordance with the MSDS and the precautions recommended by the supplier. DO NOT REMOVE THIS PRODUCT LABEL. GT INDUSTRIES 800 RAVIA RD. SULPHUR, LA 70663 PH# 318-583-9278 EMERGENCY PHONE 1-800-641-4357

INGREDIENTS AND APPEARANCE

HELIUM 
helium gas

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 61095-300
Route of Administration	RESPIRATORY (INHALATION)

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Helium (UNII: 206GF3GB41) (Helium - UNII:206GF3GB41)	Helium	990 mL  in 1 L

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61095-300-01	622 L in 1 CYLINDER
2	NDC: 61095-300-02	368 L in 1 CYLINDER
3	NDC: 61095-300-03	651 L in 1 CYLINDER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved medical gas		01/01/1994

Labeler - GT Industries Inc (844779546)

Establishment
Name	Address	ID/FEI	Business Operations
GT Industries Inc		844779546	manufacture