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 (canonical bytes are SHA-256 checked before publication)

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

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

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#

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

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.