FDA label 565cf014-1366-5315-e054-00144ff8d46c

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
8d886ec3-8ccf-4fd0-84d6-de9e858da0fb
SPL ID
565cf014-1366-5315-e054-00144ff8d46c
Version
2
Effective date
2017-08-09
Source export date
2026-08-01
Source partition
11
Source file
https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-08-01/8ac060fefb6f4d67c41cc2c9e4330286ca93c48094c18386c11bf706a1d8bd34/drug-label-0011-of-0014.json.zip
Source manifest SHA-256
bdd1454d0606b622b70458a306b8a10d8a8787db06fd9f46e69c7f7a4524b630
Import run
20260801T225920Z
Imported at
2026-08-01 23:31:18

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

WARNINGS: Sympathomimetic amines should be used with caution in patients with hypertension, ischemic heart disease, diabetes mellitus, increased intraocular pressure, hyperthyroidism, or prostatic hypertrophy. Sympathomimetics may produce central nervous system stimulation with convulsions or cardiovascular collapse with accompanying hypotension. DO NOT EXCEED RECOMMENDED DOSAGE.

Adverse reactions cross-check#

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

adverse reactions

ADVERSE REACTIONS: Mild central nervous system stimulation, especially in those patients who are hypersensitive to sympathomimetic drugs, may occur. Nervousness, excitability, restlessness, dizziness, weakness, and insomnia may also occur. Headache and drowsiness have also been reported. Large doses may cause lightheadedness, nausea and/or vomiting. Sympathomemitic drugs have also been associated with certain untoward reactions including fear, anxiety, tenseness, anxiety, restlessness, tremor, weakness, pallor, respiratory difficulty, dysuria, insomnia, hallucination, convulsion, CNS depression, arrhythmias, and cardiovascular collapse with hypotension.