FDA label 230d1e93-063b-4349-a1e8-ee1ce9312b80

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
e7d6dfe1-d8ad-4daf-9c6a-5f42e3e19138
SPL ID
230d1e93-063b-4349-a1e8-ee1ce9312b80
Version
3
Effective date
2020-06-02
Source export date
2026-10-12
Source partition
4
Source file
https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/b939c18fdf51df171cf60ce5558819d08ac66bb16bb9991d48cbec91028d783e/drug-label-0004-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:36:33

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

WARNINGS Potassium phosphates must be diluted before use. WARNING: This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum. Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration. To avoid potassium or phosphate intoxication, infuse solutions containing potassium phosphates slowly. In patients with severe renal or adrenal insufficiency, administration of potassium phosphates may cause potassium intoxication, infusing high concentrations of phosphate may cause hypocalcemia, and calcium levels should be monitored.

Adverse reactions cross-check#

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

adverse reactions

ADVERSE REACTIONS Adverse reactions involve the possibility of combined potassium and phosphate intoxication from overdosage. The signs and symptoms of potassium intoxication include paresthesias of the extremities, flaccid paralysis, listlessness, mental confusion, weakness and heaviness of the legs, hypotension, cardiac arrhythmias, heartblock, electrocardiographic abnormalities such as disappearance of P waves, spreading and slurring of the QRS complex with development of a biphasic curve and cardiac arrest. Phosphate intoxication results in a reduction of serum calcium, and the symptoms are those of hypocalcemic tetany, (see WARNINGS ).

Reported adverse events (FAERS/openFDA)#

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