Home FDA labels af80be4e-4448-471d-8017-e19e463be8c3 FDA label af80be4e-4448-471d-8017-e19e463be8c3 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 beace9b2-bfea-4455-a6f4-80c639934ac7
SPL ID af80be4e-4448-471d-8017-e19e463be8c3
Version 1
Effective date 2012-05-03
Source export date 2026-08-01
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/2026-08-01/4d7120b2932458966cd5c2f0e3ab49319f616f09498d059c9ff283a8dac64565/drug-label-0006-of-0014.json.zip
Source manifest SHA-256 bdd1454d0606b622b70458a306b8a10d8a8787db06fd9f46e69c7f7a4524b630
Import run 20260801T225920Z
Imported at 2026-08-01 23:11:58 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.