FDA label 0bfb8e68-5a65-4994-bbf0-d3d926371ce9

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: 0bfb8e68-5a65-4994-bbf0-d3d926371ce9
SPL ID: 0bfb8e68-5a65-4994-bbf0-d3d926371ce9
Version: 1
Effective date: 2011-03-23
Source export date: 2026-10-12
Source partition: 4
Source file: https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/b939c18fdf51df171cf60ce5558819d08ac66bb16bb9991d48cbec91028d783e/drug-label-0004-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 01:35:20

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		0bfb8e68-5a65-4994-bbf0-d3d926371ce9	id
spl set id		0bfb8e68-5a65-4994-bbf0-d3d926371ce9	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 Sympathomimetic amines should be used with caution in patients with hypertension, diabetes mellitus, heart disease, peripheral vascular disease, increased intraocular pressure, hyper-thyroidism, or prostatic hypertrophy.

Adverse reactions cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Adverse reactions sections page 1 of 1 · 1 matching rows.

adverse reactions

ADVERSE REACTIONS Gastrointestinal: nausea and vomiting. Cenetral Nervous System: nervousness, dizziness, sleeplessness, lightheadedness, tremor, hallucin-ations, convulsions, CNS depression, fear, anxiety, headache, increased irritability or excitement. Cardiovascular: palpitations, tachycardia, cardiovascular collapse and death. General: weakness. Respiratory: respiratory difficulties.

Reported adverse events (FAERS/openFDA)#

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