FDA label e3525c70-6ec5-420d-e053-2a95a90a75c5

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
bcd069ef-8f16-4dbb-8829-0f152d42687d
SPL ID
e3525c70-6ec5-420d-e053-2a95a90a75c5
Version
4
Effective date
2022-07-08
Source export date
2026-11-06
Source partition
6
Source file
https://download.open.fda.gov/drug/label/drug-label-0006-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-11-06/10387d7618367cd955339e75d48af3d11f99f789153db05c529d9fad6eccc645/drug-label-0006-of-0014.json.zip
Source manifest SHA-256
4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run
20261108T063105Z
Imported at
2026-11-08 07:22:34

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 Enter section text here Do not use in children under 12 years of age unless directed by a physician Ask a doctor before use if you have ■ glaucoma ■ a breathing problem such as emphysema or chronic bronchitis ■ difficulty in urination due to enlargement of the prostate gland Ask a physician or pharmacist before use if you are ■ taking sedatives or tranquilizers When using this product ■ you may get drowsy ■ avoid alcoholic beverages ■ be careful when driving a motor vehicle or operating machinery ■ alcohol, sedatives, and tranquilizers may increase the drowsiness effect 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.