FDA.reportPublic FDA data

FDA label d04dff75-58eb-4656-9956-5e7cc64a3700

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
b1c00853-695a-4859-6c8b-22374a98f46d
SPL ID
d04dff75-58eb-4656-9956-5e7cc64a3700
Version
21
Effective date
2021-08-02
Source export date
2026-09-28
Source partition
5
Source file
https://download.open.fda.gov/drug/label/drug-label-0005-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/9839785a692b692224cd5f90f9e3a9514c9923a6f521ab83eed3bedc7c0e1d05/drug-label-0005-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:30:32

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

WARNINGS Avoid overdosage. Keep out of the reach of children. Pediatric Use: Polysorbates have been associated with E-Ferol syndrome (thrombocytopenia, renal dysfunction, hepatomegaly, cholestasis, ascites, hypotension and metabolic acidosis) in low birthweight infants.

Adverse reactions cross-check#

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Adverse reactions sections page 1 of 1 · 1 matching rows.

adverse reactions

ADVERSE REACTIONS See OVERDOSAGE section. Anaphylactic shock and death have been reported using the intravenous route. Allergic reactions have been reported rarely with administration of AQUASOL A TM Parenteral including one case of an anaphylactoid type reaction.

Reported adverse events (FAERS/openFDA)#

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