FDA label 1b9e0736-03bf-43fd-a1e2-5d2882c8f9e7
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
- b38d62a7-24cb-4389-b06b-7d7788a1489f
- SPL ID
- 1b9e0736-03bf-43fd-a1e2-5d2882c8f9e7
- Version
- 11
- Effective date
- 2010-12-18
- Source export date
- 2026-10-12
- Source partition
- 1
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-10-12/7928c8e8c6256620071a8b7e5b93eb8dfa543649c08d17a01ea02251012ba58c/drug-label-0001-of-0014.json.zip
- Source manifest SHA-256
- 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
- Import run
- 20261013T011858Z
- Imported at
- 2026-10-13 01:26:21
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 | 1b9e0736-03bf-43fd-a1e2-5d2882c8f9e7 | id | |
| spl set id | b38d62a7-24cb-4389-b06b-7d7788a1489f | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
WARNINGS: Sympathomimetic amines should be used withcaution in patients with hypertension, ischemic heart disease, diabetes mellitus, increased intraocular pressure, hyperthyroidism, or prostatic hypertrophy. Sympathomimetics may produce central nervous system stimulation with convulsions 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: Nervousness or insomnia may occur on rare occasions with RE Phenylephrine 1.5 mg/Guaifenesin 20 mg Drops but is usually mild and transitory. Other reported adverse reactions with the components of this formulation include: nausea, vomiting, epigastric distress, diarrhea, rash, dizziness, weakness, tightness of chest, angina pain, abdominal pain, irritability, palpitation, headache, incoordination, tremor, difficulty in urination, dysuria, thrombocytopenia, leukopenia, convulsions, hypertension, hypotension, anorexia, constipation, visual disturbances. 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.