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FDA Drug information

Carbon Dioxide-Air Mixture

Read time: 1 mins
Marketing start date: 23 Nov 2024

Summary of product characteristics


Effective Time

20231116

Version

5

Spl Product Data Elements

Carbon Dioxide-Air Mixture Carbon Dioxide-Air Mixture NITROGEN CARBON DIOXIDE CARBON DIOXIDE OXYGEN OXYGEN

Application Number

NDA205849

Brand Name

Carbon Dioxide-Air Mixture

Generic Name

Carbon Dioxide-Air Mixture

Product Ndc

46123-115

Product Type

HUMAN PRESCRIPTION DRUG

Route

RESPIRATORY (INHALATION)

Package Label Principal Display Panel

COMPRESSED GAS, N.O.S. (% AIR, USP % CARBON DIOXIDE, USP) UN1956 Rx only. WARNING: Administration of this gas mixture 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 gas mixtures, and if 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. WARNING: CONTAINS GAS UNDER PRESSURE; MAY EXPLODE IF HEATED. MAY INCREASE RESPIRATION AND HEARTRATE. 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 preventive device in the piping. Use only with equipment rated for the cylinder pressure. Close valve after each use and when empty. Protect from sunlight when ambient temperature exceeds 52 C (125 F). Read and follow the Safety Data Sheet (SDS) before use. FIRST AID: IF ACCIDENTALLY INHALED: Remove person to fresh air and keep comfortable for breathing. Get medical advice/attention. CAS: AIR 132259-10-0, CARBON DIOXIDE 124-38-9 DO NOT REMOVE THIS PRODUCT LABEL. Roberts Oxygen Company, Inc. PO Box 5507 Rockville, MD 20855 301-948-8100 air carbon dioxide mix

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