FDA label 09cc14a2-9eed-4d42-92a1-f0adfb912107

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
5e13049d-2491-491b-a49c-de6a40ce0f1d
SPL ID
09cc14a2-9eed-4d42-92a1-f0adfb912107
Version
14
Effective date
2021-09-25
Source export date
2026-10-22
Source partition
8
Source file
https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-22/0bafccaf0213baa649cda9c1c2365d28432e10cf46f4167b2ea41290b5cac2b8/drug-label-0008-of-0014.json.zip
Source manifest SHA-256
5de9d3c3492926d1703b492ae4d29b036ac5be73edfcb92a6cd5eb95a2acef9c
Import run
20261023T001338Z
Imported at
2026-10-23 00:58:39

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 Do not use in children under 12 years of age Ask a doctor before use if you have a breathing problem such as asthma, emphysema or chronic bronchitis difficulty in urination due to enlargement of the prostate gland glaucoma Ask a doctor or pharmacist before use if you are taking any other drugs. When using this product avoid alcoholic beverages take only at bedtime Stop use and ask a doctor if sleeplessness persists continuously for more than two weeks. Insomnia may be a symptom of a serious underlying medical illness. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Reported adverse events (FAERS/openFDA)#

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