FDA label 0cc8e112-1821-43ad-835d-b083edc9f43d
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
- SPL set ID
- 85c08b62-8de0-42d2-8cdc-fe42e6b605d7
- SPL ID
- 0cc8e112-1821-43ad-835d-b083edc9f43d
- Version
- 8
- Effective date
- 2015-02-24
- 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 01:35:22
Harmonized identifier links#
Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| spl id | 0cc8e112-1821-43ad-835d-b083edc9f43d | id | |
| spl set id | 85c08b62-8de0-42d2-8cdc-fe42e6b605d7 | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
WARNINGS PLASMA-LYTE 56 and 5% Dextrose Injection (Multiple Electrolytes and Dextrose Injection, Type 1, USP) is not indicated for the primary treatment of severe metabolic acidosis. Hypersensitivity/infusion reactions, including anaphylactoid reactions, have been reported with PLASMA-LYTE 56 and 5% Dextrose Injection (Multiple Electrolytes and Dextrose Injection, Type 1, USP). Stop the infusion immediately if signs or symptoms of a hypersensitivity reaction develop, such as tachycardia, chest pain, dyspnea and flushing. Appropriate therapeutic countermeasures must be instituted as clinically indicated. Solutions containing dextrose should be used with caution, if at all, in patients with known allergy to corn or corn products. PLASMA-LYTE 56 and 5% Dextrose Injection (Multiple Electrolytes and Dextrose Injection, Type 1, USP) should not be administered simultaneously with blood through the same administration set because of the possibility of pseudoagglutination or hemolysis. Depending on the volume and rate of infusion, the intravenous administration of PLASMA-LYTE 56 and 5% Dextrose Injection (Multiple Electrolytes and Dextrose Injection, Type 1, USP) can cause fluid overload resulting in dilution of serum electrolyte concentrations, overhydration, congested states, pulmonary edema or acid-base imbalance. The risk of dilutional states is inversely proportional to the electrolyte concentrations of the injection. The risk of fluid overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations of the injection. Monitor changes in fluid balance, electrolyte concentrations, and acid base balance during prolonged parenteral therapy or whenever the condition of the patient or the rate of administration warrants such evaluation. PLASMA-LYTE 56 and 5% Dextrose Injection (Multiple Electrolytes and Dextrose Injection, Type 1, USP) should be administered with particular caution, if at all, to hypervolemic or overhydrated patients. PLASMA-LYTE 56 and 5% Dextrose Injection (Multiple Electrolytes and Dextrose Injection, Type 1, USP) should be administered with particular caution, if at all, to patients with conditions that may cause sodium retention, fluid overload and edema. Solutions containing magnesium should be used with caution, if at all, in patients with hypermagnesemia or conditions predisposing to hypermagnesemia, including but not limited to severe renal impairment or magnesium therapy such as for eclampsia and myasthenia gravis. PLASMA-LYTE 56 and 5% Dextrose Injection (Multiple Electrolytes and Dextrose Injection, Type 1, USP) is not indicated for the treatment of hypomagnesemia. PLASMA-LYTE 56 and 5% Dextrose Injection (Multiple Electrolytes and Dextrose Injection, Type 1, USP) should be administered with particular caution, if at all, to patients with alkalosis or at risk for alkalosis. Excess administration of PLASMA-LYTE 56 and 5% Dextrose Injection (Multiple Electrolytes and Dextrose Injection, Type 1, USP) can result in metabolic alkalosis. PLASMA-LYTE 56 and 5% Dextrose Injection (Multiple Electrolytes and Dextrose Injection, Type 1, USP) is not indicated for the treatment of hypochloremic hypokalemic alkalosis and should be used with caution, if at all, in patients with hypochloremic hypokalemic alkalosis. PLASMA-LYTE 56 and 5% Dextrose Injection (Multiple Electrolytes and Dextrose Injection, Type 1, USP) contains no calcium, and an increase in plasma pH due to its alkalinizing effect may lower the concentration of ionized (not protein-bound) calcium. PLASMA-LYTE 56 and 5% Dextrose Injection (Multiple Electrolytes and Dextrose Injection, Type 1, USP) should be administered with particular caution, if at all, to patients with hypocalcemia. PLASMA-LYTE 56 and 5% Dextrose Injection (Multiple Electrolytes and Dextrose Injection, Type 1, USP) should be administered with particular caution, if at all, to patients with hyperkalemia or conditions predisposing to hyperkalemia (such as severe renal impairment or adrenocortical insufficiency, acute dehydration, or extensive tissue injury or burns) and in patients with cardiac disease. In patients with diminished renal function, administration of PLASMA-LYTE 56 and 5% Dextrose Injection (Multiple Electrolytes and Dextrose Injection, Type 1, USP) may result in sodium and/or potassium or magnesium retention.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS Post-marketing Adverse Reactions The following adverse reactions have been reported with PLASMA-LYTE products with Dextrose. Adverse reactions are listed by MedDRA System Organ Class (SOC), then by Preferred Term in order of severity, where feasible. • Immune System Disorders: Hypersensitivity/infusion reactions, including Anaphylactoid reaction, and the following manifestations: Hypotension, Chest discomfort, Dyspnea, Wheezing, Flushing, Hyperemia, Asthenia, Urticaria, Cold sweat, Pyrexia, Chills • Metabolism and Nutrition Disorders: Hyperkalemia, Hyperglycemia • General Disorders and Administration Site Conditions: Infusion site reactions (e.g., Burning sensation) Other adverse reactions, reported with PLASMA-LYTE products are: • Other manifestations of hypersensitivity/infusion reactions: Tachycardia, Palpitations, Chest Pain, Respiratory rate increased, Feeling abnormal, Piloerection, Edema peripheral • Infusion site pain
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.