Helium Gas
FDA Label NDC 17575-005

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Agl Inhalation Therapy Co. for the product Helium (NDC 17575-005). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Package Label.Principal Display Panel

AGL
Auto Gas Light
HELIUM,
COMPRESSED
USP
U.N. 1046
AGL-8-D-103-2  (11/09)
NON-FLAMMABLE GAS     2
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 of administration of helium and is familiar with indications, dosages and 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. User shall secure cylinder in use and in storage. Use in upright position. Use equipment rated for cylinder pressure. Use a back flow preventive device in the piping. Cylinder temperature should not exceed 52 degrees C (125 degrees F). Close valve after each use and when empty. Keep valve protective cap in place when not in use, if so equipped. Use in accordance with the Material Safety Data Sheet (MSDS). Inhaling Helium to alter 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
RETURN WITH 25 PSIG.
AGL Inhalation Therapy Co. Clifton, NJ 07015
973-478-5100
973-478-5000
Pressure:          PSIG at 70 degrees F.
Size
Contents      liters

Helium (Helium)

Helium (Helium)

* Please review the disclaimer below.