FDA label 735dd6ac-9f10-446d-881f-af4d9acde8e0

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: b100f072-55e5-4d99-964d-f1bd2df65227
SPL ID: 735dd6ac-9f10-446d-881f-af4d9acde8e0
Version: 2
Effective date: 2017-11-06
Source export date: 2026-10-12
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/2026-10-12/7928c8e8c6256620071a8b7e5b93eb8dfa543649c08d17a01ea02251012ba58c/drug-label-0001-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 01:26:09

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		735dd6ac-9f10-446d-881f-af4d9acde8e0	id
spl set id		b100f072-55e5-4d99-964d-f1bd2df65227	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: Do not give to children under 12 years of age unless directed by a doctor. Do not take unless directed by a doctor if you have: trouble urinating due to an enlarged prostate gland, glaucoma, a breathing problem such as emphysema or chronic bronchitis. Do not take if you are taking sedatives or tranquilizers,without ¬first consulting a doctor. When using this product: do not exceed recommended dosage drowsiness may occur, avoid alcoholic drinks, alcohol, sedatives, and tranquilizers may increase drowsiness, be careful when driving a motor vehicle or operating machinery

Reported adverse events (FAERS/openFDA)#

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