FDA label 44837ec9-1267-4eaf-95f4-6bac78aefdd1

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
18b660e8-a70b-4393-b1f3-c4aa3f8597aa
SPL ID
44837ec9-1267-4eaf-95f4-6bac78aefdd1
Version
3
Effective date
2017-07-19
Source export date
2026-09-28
Source partition
6
Source file
https://download.open.fda.gov/drug/label/drug-label-0006-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/e0861bcde1444ef952820955caafc6f3fd29783e5ade07a13d933aa3336b399f/drug-label-0006-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:40:29

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

WARNINGS Strongly hypertonic solutions. Must be properly diluted and thoroughly mixed before injection. Contains no phosphate. Patients receiving TPN solutions containing concentrated dextrose may also require phosphate in addition to Nutrilyte II. It is necessary to take into consideration the calcium and magnesium ions in this solution in order to avoid precipitation where phosphate is present in the diluted solution. Phosphate (10-15 mEq/L), calcium (5 mEq/L) and magnesium (5-10 mEq/L) rarely are incompatible when properly mixed. Higher levels must be added cautiously with adequate mixing (avoid layering) and inspection. Additional calcium and phosphate may be added to alternate bottles. If additional phosphate is required, it is essential to consider the salt form because of pre-existing levels of potassium and the final concentration of phosphate in the infusate. Each 20 mL of Nutrilyte II contains 20 mEq of potassium. Patient requirements should be carefully evaluated prior to the addition of any potassium salt to a solution containing Nutrilyte II. 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.

Adverse reactions cross-check#

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adverse reactions

ADVERSE REACTIONS Symptoms may result from an excess or deficit of one or more of the ions present in Nutrilyte II Multi- Electrolyte Concentrate. Therefore, frequent monitoring of blood electrolyte levels is essential. Sodium excess can cause edema and subsequent congestive heart failure in patients with cardiovascular insufficiency. Potassium excess can cause an abnormal electrocardiogram, cardiac arrhythmias leading to cardiac arrest, paresthesias and flaccid paralysis, mental confusion and weakness. Potassium deficit can impair neuromuscular function and cause intestinal dilatation and ileus. Magnesium excess can cause muscular weakness, flushing, sweating, hypotension, circulatory collapse and depression of cardiac and central nervous system function. Magnesium deficiency can cause hyperirritability psychotic behavior, tachycardia, hypertension and neuromuscular dysfunction. Calcium excess can cause depression, headaches, drowsiness, disorientation, syncope, dysphagia, hypotonia of skeletal and smooth muscles, arrhythmias and coma. Calcium deficits can produce neuromuscular hyperexcitability (paresthesias, cramps, tetany and grand mal seizures). Phosphorus deficiency may lead to impaired tissue oxygenation and acute hemolytic anemia. Relative to calcium, excessive phosphorus intake can precipitate hypocalcemia with ensuing neuromuscular hyperexcitability.

Reported adverse events (FAERS/openFDA)#

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