FDA label b9f79583-eabd-4671-b349-5b1485af9f80
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
- 231c5dae-5834-4b49-b1b1-84b31e81d4d9
- SPL ID
- b9f79583-eabd-4671-b349-5b1485af9f80
- Version
- 2
- Effective date
- 2009-11-03
- Source export date
- 2026-09-28
- Source partition
- 6
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0006-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/e0861bcde1444ef952820955caafc6f3fd29783e5ade07a13d933aa3336b399f/drug-label-0006-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 05:41:59
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 | b9f79583-eabd-4671-b349-5b1485af9f80 | id | |
| spl set id | 231c5dae-5834-4b49-b1b1-84b31e81d4d9 | 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 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 excitability, especially in children. At doses higher than the recommended dose, nervousness, dizziness or sleeplessness may occur. Do not exceed recommended dosage. Administration of dextromethorphan may be accompanied by histamine release and should be used with caution in atopic children.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
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. Dextromethorphan: Drowsiness, dizziness, and GI disturbance. To report SUSPECTED ADVERSE REACTIONS, contact Hi-Tech Pharmacal Co., Inc at 1-800-262-9010. The signs, symptoms and treatment described below are those for H 1 antihistamines, pseudoephedrine and dextromethorphan overdose.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.