FDA label 5822bba9-0cb5-4388-ab58-2ad6f825a5b2

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
acfc67b6-7919-4b30-81a7-087efd1b05cd
SPL ID
5822bba9-0cb5-4388-ab58-2ad6f825a5b2
Version
2
Effective date
2011-08-23
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 01:25:35

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

WARNINGS Sympathomimetic amines should be used judiciously and sparingly in patients with hypertension, diabetes, ischemic heart disease, hyperthyroidism, increased intraocular pressure, or prostatic hypertrophy. (See CONTRAINDICATIONS ). Sympathomimetic amines may produce CNS stimulation with convulsions or cardiovascular collapse with accompanying hypotention. The elderly (60 years and older) are more likely to exhibit adverse reactions. A persistent cough may be a sigh of a serious condition. If cough persists for more than one week, tends to recur, or is accompanied by fever, rash, or persistent headache, consult a doctor. Patient re-evaluation should be considered. Antihistamines may cause hyperexcitability, especially in children. At doses higher than the recommended doses, nervousness, dizziness or sleeplessness may occur. 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

Carbetapentane Citrate: Adverse effects associated with carbetapentane citrate are rare, but nausea and/or other gastrointestinal disturbances sometimes occur. Phenylephrine Hydrochloride: Sympathomimetics may cause mild central nervous system stimulation, especially in those who are hypersensitive to sympathomimetic drugs. Nervousness, excitability, restlessness, dizziness, weakness and insomnia may also occur. Headache and drowsiness have also been reported. Sympathomimetic drugs have also been associated with certain untoward reactions including fear, anxiety, tenseness, restlessness, tremor, weakness, pallor, respiratory difficulty, dysuria, insomnia, hallucinations, convulsions, CNS depression, CNS stimulation, nervousness, increased heart rate or blood pressure, arrhythmias and cardiovascular collapse with hypotension. Dexchlorpheniramine Maleate: Slight to moderate drowsiness may occur and is the most frequent side effect. Sedation, dizziness, diplopia, vomiting, diarrhea, dry mouth, headache, nervousness, nausea, anorexia, heartburn, weakness, polyuria, and dysuria, and rarely, excitability in children. Urinary retention may occur in patients with prostatic hypertrophy.

Reported adverse events (FAERS/openFDA)#

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