FDA label 37aef3f9-3ebf-4033-be5f-0504e1572b19
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
- SPL set ID
- 37aef3f9-3ebf-4033-be5f-0504e1572b19
- SPL ID
- 37aef3f9-3ebf-4033-be5f-0504e1572b19
- Version
- 1
- Effective date
- 2011-03-14
- 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 05:13:15
Harmonized identifier links#
Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| spl id | 37aef3f9-3ebf-4033-be5f-0504e1572b19 | id | |
| spl set id | 37aef3f9-3ebf-4033-be5f-0504e1572b19 | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
WARNINGS Sympathomimetic amines should be used judiciously and sparingly in patients with hypertension, diabetes, ischemic heart disease. hyperthyroidism, increased intraocular pressure, and prostatic hypertrophy. 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 excitability, especially in children. At dosages higher than the recommended dose, nervousness, dizziness or sleeplessness may occur. Do not exceed recommended dosage.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
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, pallor, 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.