FDA label 6d0faccd-2a98-431c-ae27-5f0c7e7f854b

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
14a2b1ab-f94b-45f1-b5c3-dce751648e93
SPL ID
6d0faccd-2a98-431c-ae27-5f0c7e7f854b
Version
4
Effective date
2019-01-17
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 01:35:09

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 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 decreases blood sugar in diabetic patients. In the untreated diabetic, the rate of alcohol metabolism is slowed. As a nutrient, alcohol supplies only calories. Given alone, it may cause or potentiate vitamin deficiencies and certain liver alterations. Alcohol crosses the placenta rapidly and enters the fetal circulation. It may also be found in the milk of lactating women. The use of these solutions in pregnancy should be carefully considered.

Adverse reactions cross-check#

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

adverse reactions

ADVERSE REACTIONS 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 in 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, vein irritation. Use of the largest available peripheral vein and a well-placed, small bore needle is recommended.

Reported adverse events (FAERS/openFDA)#

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