FDA label b00ff7bd-f96d-4bb4-b514-16b972c7c040

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
b00ff7bd-f96d-4bb4-b514-16b972c7c040
SPL ID
b00ff7bd-f96d-4bb4-b514-16b972c7c040
Version
1
Effective date
2011-03-11
Source export date
2026-10-12
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/2026-10-12/a497e765d824a2e2aa9e88d5f0eea2aae9dcba363989e5f163395cda5c3c9dd8/drug-label-0011-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:48:59

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

WARNINGS Sympathomimetic amines should be used judiciously and sparingly in patients with hypertension, diabetes, ischemic heart disease, hypothyroidism, increased intraocular pressure, and prostatic hyperthrophy. Sympathomimetic amines may produce CNS stimulation with convulsions or cardiovascular collapse with accompanying hypertension. The elderly (60 years and older) are more likely to exhibit adverse reaction. Antihistamines may cause excitability, especially in children. A dosages higher than the recommended dose, nervousness, dizziness or sleepiness may occur. 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 Sympathomimetic amines may cause tachycardia, palpitations, nervousness, insomnia, restlessness, headache, gastric irritation and irritability. Sympathomimetic amines have been associated with certain untoward reactions including fear, anxiety, tenseness, restlessness, tremor, weakness, respiratory difficulty, dysuria, insomnia, hallucinations, convulsions. CNS depression, arrhythmias and cardiovascular collapse with hypotension. Urinary retention may occur in patients with prostatic hypertrophy. Antihistamines and anticholinergics may cause drowsiness, dizziness, blurred vision and excessive dryness of the nose, throat and mouth.

Reported adverse events (FAERS/openFDA)#

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