Home FDA labels 96a13732-4d52-4cb3-803d-97abd23e3acf FDA label 96a13732-4d52-4cb3-803d-97abd23e3acf 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 cef1610e-f293-4fa2-aecd-ac5d4cbd3be6
SPL ID 96a13732-4d52-4cb3-803d-97abd23e3acf
Version 2
Effective date 2011-03-21
Source export date 2026-10-12
Source partition 5
Source file https://download.open.fda.gov/drug/label/drug-label-0005-of-0014.json.zip
Source object key raw/openfda/drug-label/2026-10-12/13cbfcd236c665f0ee69e2d9141331148dcdff45d1679c92f029cfba27dd74a2/drug-label-0005-of-0014.json.zip
Source manifest SHA-256 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run 20261013T011858Z
Imported at 2026-10-13 01:42:52 Harmonized identifier links# Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
Harmonized identifiers page 1 of 1 · 2 matching rows.
Warnings cross-check# openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Warnings sections page 1 of 1 · 1 matching rows.
warnings WARNINGS Use in Pregnancy: Safety for use during pregnancy has not been established. Nursing Mothers: Use with caution in nursing mothers. Special Risk Patients: Use with caution in patients with hypertension or ischemic heart disease, and persons over 60 years.
Adverse reactions cross-check# openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
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. Sympathomimetic Amines: Convulsions, CNS stimulation, cardiac arrythmias, respiratory difficulty, increased heart rate or blood pressure, hallucinations, tremors, nervousness, insomnia, weakness, pallor and dysuria. Dextromethorphan: Drowsiness and GI disturbance.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.