FDA label a0a9fdf2-53cc-53ee-e053-2995a90a8693

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
a0a9fdf2-53cd-53ee-e053-2995a90a8693
SPL ID
a0a9fdf2-53cc-53ee-e053-2995a90a8693
Version
1
Effective date
2020-03-12
Source export date
2026-08-01
Source partition
1
Source file
https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-08-01/0689a4374f1490600b5244071db3b04bd3bbc29ceda7a856edb8225323adf20a/drug-label-0001-of-0014.json.zip
Source manifest SHA-256
bdd1454d0606b622b70458a306b8a10d8a8787db06fd9f46e69c7f7a4524b630
Import run
20260801T225920Z
Imported at
2026-08-01 23:00:38

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 Allergy alert: do not use in case of hypersensitivity (allergy) to any of the ingredients. Ask a doctor before use if you have hepatopathy depression neural disease Possible side effects are sleepiness increase in liver enzymes feeling very tired and weak Stop use and ask a doctor if you experience any side effects not listed on this carton. Ask a doctor or pharmacist before use if you are taking sleeping pills, tranquilizers, sedatives or other medicines. When using this product avoid alcoholic drinks alcohol, sleeping pills, tranquilizers and sedatives may increase drowsiness and may impair mental and/or physical abilities be careful when driving a motor vehicle or operating machinery If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children.