Helium
FDA Label NDC 61095-300

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Gt Industries Inc for the product Helium (NDC 61095-300). 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.

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Package Label.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

Helium (Helium)

Helium (Helium)

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