FDA label e9525783-8fd3-46a7-aa25-770decedb5ba
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
- ce2276f0-1026-432b-bb94-3862e812c424
- SPL ID
- e9525783-8fd3-46a7-aa25-770decedb5ba
- Version
- 11
- Effective date
- 2010-12-18
- Source export date
- 2026-09-28
- Source partition
- 3
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/fd09911bd1bc81f7f2faeb048e63855fe224e494376ae919a0035190e315c050/drug-label-0003-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 05:21:59
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 | e9525783-8fd3-46a7-aa25-770decedb5ba | id | |
| spl set id | ce2276f0-1026-432b-bb94-3862e812c424 | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
WARNINGS: Sympathomimetic amines shoud be used with caution in patients with hypertension, ischemic heart disease, diabetes mellitus, increased intraocular pressure, hyperthyroidism, or prostatic hypertrophy. Sympathomimetics may produce central nervous system stimulation with conclusions or cardiovascular collapse with accompanying hypotension. 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: Dextromethorphan HBr: Adverse effects with Dextromethorpahn HBr are rare, but nausea and/or other gastrointestinal disturbances, headache, slight dizziness and drowsiness can occur. Phenylephrine HCl: Hyper-reactive individuals may display ephedrine-like reactions such as tachycardia, palpitations, headache, dizziness, or nausea. Sympathomimetics have been associated with certain adverse reactions including fear, anxiety, nervousness, restlessness, tremor, weakness, pallor, respiratory difficulty, dysuria, insomnia, hallucinations, convulsions, CNS depression, arrhythmias, and cardiovascular collapse with hypotension. Chlorpheniramine Maleate: Antihistamines may cause sedation, dizziness, diplopia, vomtting, diarrhea, dry mouth, headache, nervousness, nausea, anorexia, heartburn, weakness, polyuria and, rarely, excitability in children. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.