FDA label 8d35b452-860a-44b0-9374-b65abc37b6ed
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
- 3303b564-f371-478e-28b6-3a91f5eae207
- SPL ID
- 8d35b452-860a-44b0-9374-b65abc37b6ed
- Version
- 10
- Effective date
- 2013-05-17
- 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 01:35:17
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 | 8d35b452-860a-44b0-9374-b65abc37b6ed | id | |
| spl set id | 3303b564-f371-478e-28b6-3a91f5eae207 | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
WARNINGS Alcohol should be used cautiously, if at all, in patients with liver impairment, in the presence of shock, following cranial surgery, in actual or anticipated postpartum hemorrhage or in the presence of significant renal impairment. Alcohol will decrease blood sugar in diabetic patients. In the untreated diabetic the rate of alcohol metabolism will be slowed. As a nutrient, alcohol supplies only calories. Given alone, it may cause or potentiate vitamin deficiencies and disturbances of liver function. Alcohol crosses the placenta rapidly and enters the fetal circulation. It may also be found in the milk of lactating women. The use of this preparation in pregnancy should be carefully deliberated. The intravenous administration of this solution can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS Reactions which may occur because of the solution or the technique of administration include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation and hypervolemia. Alcoholic intoxication may occur with too rapid infusion. Vertigo, flushing, disorientation (especially in elderly patients), or sedation may also occur. An alcoholic odor may be noted on the breath. Generally, these effects can be avoided by slowing the rate of infusion. Too rapid infusion of hypertonic solutions may cause local pain and rarely, excessive vein irritation. Use of the largest available peripheral vein and a small bore needle is recommended. If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination if deemed necessary.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.