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FDA label 7300a924-6641-4995-ba16-d33f68798fcf

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
cd0f4e44-63e2-4a0b-b646-43d443ba25bc
SPL ID
7300a924-6641-4995-ba16-d33f68798fcf
Version
2
Effective date
2012-04-13
Source export date
2026-08-17
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/2026-08-17/860dc0eef34653a2a2dab2761771be9cda8410b7a1f078032b37381cbdbb4107/drug-label-0006-of-0014.json.zip
Source manifest SHA-256
ca19d5b1416b6b66a9d383bfdc77d90e91adfeefe16ffcc1ac6b06ceb90d8d73
Import run
20260818T065550Z
Imported at
2026-08-18 07:31:45

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

WARNINGS Do not exceed recommended dosage. 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 section.) 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. Administration of dextromethorphan may be accompanied by histamine release and should be used with caution in atopic children.

Adverse reactions cross-check#

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Adverse reactions sections page 1 of 1 · 1 matching rows.

adverse reactions

ADVERSE REACTIONS Antihistamines may cause 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. Dextromethorphan may cause drowsiness, dizziness, and GI disturbance. Sympathomimetic Amines: Convulsions, CNS stimulation, cardiac arrhythmias, respiratory difficulties, increased heart rate or blood pressure, hallucinations, tremors, nervousness, insomnia, weakness, pallor and dysuria.