FDA label 1e3ecf30-e5e7-49b2-a35b-7a66c0e2b55b

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: cade2f27-fc17-4538-bcdc-67bafd85371d
SPL ID: 1e3ecf30-e5e7-49b2-a35b-7a66c0e2b55b
Version: 2
Effective date: 2025-04-03
Source export date: 2026-09-28
Source partition: 7
Source file: https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/bb1af06e95bcf9567b07e56fcf3a03c0cac3c7c82ff89d4c970881174949e5b7/drug-label-0007-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:45:37

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 2 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
spl id		1e3ecf30-e5e7-49b2-a35b-7a66c0e2b55b	id
spl set id		cade2f27-fc17-4538-bcdc-67bafd85371d	set_id

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 Ask a doctor before use if you have • a breathing problem such as emphysema or chronic bronchitis • glaucoma • trouble urinating due to an enlarged prostate gland Ask a doctor or pharmacist before use if you are • taking sedatives or tranquilizers When using this product • excitability may occur, especially in children • drowsiness may occur • avoid alcoholic beverages • alchohol, sedatives and tranquilizers may increase drowsiness • use caution when driving a motor vehicle or operating machinery Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 If pregnant or breast-feeding, ask a health professional before use

Reported adverse events (FAERS/openFDA)#

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