Non-proprietary name

openFDA label record#

Cross-check layer: This is openFDA JSON-derived label data. Use the corresponding DailyMed SPL as the canonical label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name
Non-proprietary name
Generic name
L- ARGININE
Manufacturer
Xseer Pharmaceuticals
Product type
HUMAN PRESCRIPTION DRUG
SPL set ID
3c6c0ac6-0d2a-b865-e063-6294a90aa3d2
SPL ID
522eebc2-ab9d-2e45-e063-6294a90a43fd
Version
2
Effective date
2026-05-19
Source export date
2026-08-01
Source partition
11
Source file
https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-08-01/8ac060fefb6f4d67c41cc2c9e4330286ca93c48094c18386c11bf706a1d8bd34/drug-label-0011-of-0014.json.zip
Source manifest SHA-256
bdd1454d0606b622b70458a306b8a10d8a8787db06fd9f46e69c7f7a4524b630
Import run
20260801T225920Z
Imported at
2026-08-01 23:29:19
Harmonized routes table
Harmonized routes
INTRAMUSCULAR, INTRAVENOUS

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings and cautions

Warnings and Precautions For intravenous administration only under the supervision of a licensed healthcare professional. This product is a hypertonic solution and should be administered cautiously to minimize the risk of vein irritation, phlebitis, or infusion-related reactions. Use with caution in patients with renal impairment, hepatic impairment, electrolyte imbalance, or acid-base disorders, as L-Arginine may affect metabolic and electrolyte status. Monitor patients for signs of hypersensitivity reactions, including rash, dyspnea, hypotension, or anaphylactoid reactions. Discontinue administration if a serious reaction occurs. Contains benzyl alcohol 2% as a preservative. Benzyl alcohol has been associated with serious adverse reactions, including fatal “gasping syndrome,” in neonates and premature infants. Use caution in patients with cardiovascular disease or compromised fluid balance, as intravenous administration may contribute to circulatory overload in susceptible individuals. Rapid or excessive administration may increase the risk of nausea, vomiting, flushing, headache, or hypotension. Protect from light and from deep freezing. Do not use if the solution is discolored, cloudy, or contains particulate matter. Use aseptic technique when entering the multiple-dose vial. Discard unused portion according to institutional policy and applicable regulations.