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
- 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
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 | ed91386c-1fa7-4121-9ab9-051e66baf9ac | id | |
| spl set id | ed91386c-1fa7-4121-9ab9-051e66baf9ac | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
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#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
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.