FDA label ed91386c-1fa7-4121-9ab9-051e66baf9ac

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
ed91386c-1fa7-4121-9ab9-051e66baf9ac
SPL ID
ed91386c-1fa7-4121-9ab9-051e66baf9ac
Version
1
Effective date
2011-03-22
Source export date
2026-10-12
Source partition
7
Source file
https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/ff22b88bd32e56cbc369af80345075227138a42b1b3ba9a84f038fd5493a7a47/drug-label-0007-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:06:11

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

WARNINGS Sympathommetic amines should be used with caution in patients with hypertension, diabetes mellitus, ischemic heart disease, peripheral vascular disease, increased intraocular pressure hyperthyroidism, or prostatic hypertrophy. Sympathomimetic amines may produce CNS stimulation and convulsions or cardiovascular collapse with accompanying hypotension. Do not exceed recommended dosage. Hypertensive crises can occur with concurrent use of pseudoephedrine or phenylephrine and MAOI, and for 14 days after stopping MAOI therapy, indomethacin, or with beta-blockers and methyldopa. If a hypertensive crisis occurs, these drugs should be discontinued immediately and therapy to lower blood pressure should be instituted. Fever should be managed by means of external cooling.

Adverse reactions cross-check#

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

adverse reactions

ADVERSE REACTIONS Hyper-reactive individuals may display ephedrine-like reactions such as tachycardia, palpitations, headache, dizziness, or nausea. Sympathomimetics have been associated with certain untoward reactions including fear, anxiety, nervousness, restlessness, tremor, weakness, pallor, respiratory difficulty, dysuria, insomnia, hallucinations, convulsions, CNS depression, arrhyhmias, and cardiovascular collapse with hypotension. No serious side effects have been reported with the use of guaifenesin.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.