FDA.reportPublic FDA data

FDA label 933b9c0d-ce62-45c9-abc5-5ede20969b61

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
57c5267c-d860-42a0-b929-51ff2743c451
SPL ID
933b9c0d-ce62-45c9-abc5-5ede20969b61
Version
2
Effective date
2011-03-08
Source export date
2026-09-28
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/2026-09-28/9c7783846d422acb0c9e59457606951c785a7d28cc631c8cc4839d0dc7c55f39/drug-label-0001-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:13:14

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, hyperthyroidism, increased intraocular pressure, or prostatic hypertrophy, (see CONTRAINDICATIONS ). Sympathomimetic amines may produce CNS stimulation with convulsions or cardiovascular collapse with accompanying hypotension. The elderly (60 years and older) are more likely to exhibit adverse reactions. Antihistamines may cause hyperexcitability, especially in children. At doses higher than the recommended doses, nervousness, dizziness or sleeplessness 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 Antihistamines Sedation, dizziness, diplopia, vomiting, diarrhea, dry mouth, headache, nervousness, nausea, anorexia, heartburn, weakness, polyuria, and dysuria, and rarely, excitability in children. Urinary retention may occur in patients with prostatic hypertrophy. Sympathomimetic Amines Convulsions, CNS stimulation, cardiac arrhythmia, respiratory difficulties, increased heart rate or blood pressure, hallucinations, tremors, nervousness, insomnia, pallor and dysuria.

Reported adverse events (FAERS/openFDA)#

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