FDA label d74e6a1d-dc30-4ed4-b98e-04011ed83fee

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
ab9979e7-0213-4376-a8e0-7791eef27ed5
SPL ID
d74e6a1d-dc30-4ed4-b98e-04011ed83fee
Version
4
Effective date
2021-01-25
Source export date
2026-10-12
Source partition
11
Source file
https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/a497e765d824a2e2aa9e88d5f0eea2aae9dcba363989e5f163395cda5c3c9dd8/drug-label-0011-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:47:42

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

SPECIAL WARNINGS The solution must be clear, colourless and free from visible particles. Use immediately after opening the container. The container must be used for a single uninterrupted administration and no residue may be used afterwards. Pregnancy and breastfeeding Ask your doctor or pharmacist for advice before taking any medicine. There are no data on possible adverse effects of the medicinal product when administered during pregnancy or breastfeeding or concerning the reproductive capacity. Therefore, the medicinal product must not be used during pregnancy and breastfeeding unless clearly necessary and only after assessing the risk/benefit ratio. Effects on ability to drive and use machines The medicine does not affect the ability to drive or use machines.

Reported adverse events (FAERS/openFDA)#

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