FDA label ea1600a2-e0af-4f6c-ab45-1160d3682449
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
- ea1600a2-e0af-4f6c-ab45-1160d3682449
- SPL ID
- ea1600a2-e0af-4f6c-ab45-1160d3682449
- Version
- 1
- Effective date
- 2011-03-18
- Source export date
- 2026-09-28
- Source partition
- 2
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/f7d2b6e3f8600cd856280ab55a9c6fa54a642647191d164f9d1110e89f3f4097/drug-label-0002-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 05:17:12
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 | ea1600a2-e0af-4f6c-ab45-1160d3682449 | id | |
| spl set id | ea1600a2-e0af-4f6c-ab45-1160d3682449 | 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. See Contraindications. Sympathomimetic amines may produce CNS stimulation and convulsions or cardiovascular collapse with accompanying hypotension. The elderly (60 years and older) are more likely to exhibit adverse reactions. 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 prostate hypertrophy. Guaifenesin may cause nausea, vomiting, diarrhea, and gastric irritation.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.