Nitric Oxide 800 Ppm

Nitric Oxide 800 Ppm
SPL v15
SPL
SPL Set ID 2c605fc0-82be-09e0-e063-6394a90a63e9
Route
RESPIRATORY (INHALATION)
Published
Effective Date 2023-08-04
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Nitric Oxide (999.2 mL)
Inactive Ingredients
Nitrogen

Identifiers & Packaging

Marketing Status
ANDA Active Since 2023-08-04

Description

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.


Medication Information

Warnings and Precautions

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.

Description

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.

Section 51945-4

Ulspira TM

(nitric oxide for inhalation)

800 PPM

Rx Only

CAUTION: HIGH PRESSURE GAS. CAN CAUSE RAPID SUFFOCATION WITHOUT WARNING. Use equipment rated for cylinder pressure. Store and use with adequate ventilation. Secure cylinder in use and storage. Close valve after each use and when empty. USE IN ACCORDANCE WITH APPROPRIATE SDS.

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.

FIRST AID: IF INHALED, remove person to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen. Get medical help.

RETURN WITH 25 PSIG.

TO BE REFILLED ONLY BY A PHARMACEUTICAL FACILITY

AUTHORIZED BY AIRGAS THERAPEUTICS, LLC

Manufactured Under Pharmaceutical Current Good Manufacturing Practices (cGMPs).

DO NOT REMOVE THIS PRODUCT LABELS

Store at 25 C (77 F) with excursions permitted between 15 - 30 C (59 – 86 F).

Volume 362 Liters

Airgas Therapeutics

An Air Liquide company

Manufactured by:

AIRGAS THERAPEUTICS, LLC

6141

Easton Road

Plumsteadville, PA 18949-0310

For Product Inquiry 1-833-ULSPIRA (857-7472)

UN 1956

COMPRESSED GAS, N.O.S. (NITRIC OXIDE, NITROGEN) 2.2

Net Weight: 0.4 kg

LOT:

EXP:

NDC 82605-005-02

Label No. ULSMD15 Rev. 00

800PPM MD15


Structured Label Content

Warnings and Precautions (34071-1)

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.

Section 51945-4 (51945-4)

Ulspira TM

(nitric oxide for inhalation)

800 PPM

Rx Only

CAUTION: HIGH PRESSURE GAS. CAN CAUSE RAPID SUFFOCATION WITHOUT WARNING. Use equipment rated for cylinder pressure. Store and use with adequate ventilation. Secure cylinder in use and storage. Close valve after each use and when empty. USE IN ACCORDANCE WITH APPROPRIATE SDS.

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.

FIRST AID: IF INHALED, remove person to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen. Get medical help.

RETURN WITH 25 PSIG.

TO BE REFILLED ONLY BY A PHARMACEUTICAL FACILITY

AUTHORIZED BY AIRGAS THERAPEUTICS, LLC

Manufactured Under Pharmaceutical Current Good Manufacturing Practices (cGMPs).

DO NOT REMOVE THIS PRODUCT LABELS

Store at 25 C (77 F) with excursions permitted between 15 - 30 C (59 – 86 F).

Volume 362 Liters

Airgas Therapeutics

An Air Liquide company

Manufactured by:

AIRGAS THERAPEUTICS, LLC

6141

Easton Road

Plumsteadville, PA 18949-0310

For Product Inquiry 1-833-ULSPIRA (857-7472)

UN 1956

COMPRESSED GAS, N.O.S. (NITRIC OXIDE, NITROGEN) 2.2

Net Weight: 0.4 kg

LOT:

EXP:

NDC 82605-005-02

Label No. ULSMD15 Rev. 00

800PPM MD15


Advanced Ingredient Data


Raw Label Data

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