FDA label 58b560c6-6e55-3389-e063-6394a90a32c9

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

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

SPL set ID
3c6cbe21-f6f4-3aeb-e063-6394a90ae5f1
SPL ID
58b560c6-6e55-3389-e063-6394a90a32c9
Version
4
Effective date
2026-08-10
Source export date
2026-10-12
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/2026-10-12/a497e765d824a2e2aa9e88d5f0eea2aae9dcba363989e5f163395cda5c3c9dd8/drug-label-0011-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:45:44

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings and cautions

Warnings and Precautions For intravenous administration under the supervision of a licensed healthcare professional. Monitor patients for hypersensitivity reactions, including rash, urticaria, dyspnea, hypotension, or anaphylactoid reactions. Discontinue administration if serious reactions occur. 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 with caution in patients with seizure disorders, as seizures have been reported in patients receiving Levocarnitine. Use caution in patients with renal impairment or compromised renal function, as accumulation of metabolites may occur. Rapid intravenous administration may increase the risk of adverse reactions such as nausea, vomiting, abdominal discomfort, headache, flushing, or dizziness. Intravenous administration should be performed cautiously to minimize infusion-related reactions or vein irritation. 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.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.